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Maeda, I., Miyashita, M., Yamagishi, A., Kinoshita, H., Shirahige, Y., Izumi, N., . . . Morita, T. (2016). Changes in relatives' perspectives on quality of death, quality of care, pain relief, and caregiving burden before and after a region-based palliative care intervention. Journal of Pain and Symptom Management, 52, 637–645. 

Study Purpose

To explore the effect of a previously developed Japan Outreach Palliative Care Trial of Integrated Regional Model (OPTIM) intervention on palliative care outcomes (quality of patient death and dying, family views on patient quality of care and pain control, and caregiver burden) in hospital, home, and palliative care unit settings

Intervention Characteristics/Basic Study Process

The OPTIM intervention focused on enhancing Japanese regional medical providers’ palliative knowledge and skills via distributions of manuals and interactive workshops and incorporating palliative care teams in educational outreach to community patients and families. The intervention also focused on holding interdisciplinary palliative care conferences and providing consumer-based information and programs on palliative care to improve regional oncologic comfort. Patients and caregivers from 23 hospitals and home-care clinics completed four questionnaires in a mailed survey sent before and following the intervention.

Sample Characteristics

  • N = 2,247    
  • AGE: 72% aged 69 years or younger (no mean age reported)
  • MALES: 29.65%, FEMALES: 70.35%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Diverse cancers (lung/gastrointestinal were most common) to support patient terminal illness 
  • OTHER KEY SAMPLE CHARACTERISTICS: Caregivers were adults, able to complete questionnaires, and did not have severe emotional distress. Two different groups of caregivers responded to pre- and postintervention surveys.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

Pre-/postdesign

Measurement Instruments/Methods

  • Care Evaluation Scale to measure 10 domains of family-perceived quality of patient care
  • Good Death Inventory to measure 18 domains of a good death in Japanese patients with cancer, included one item to measure patient pain relief 
  • Caregiving Consequences Inventory to measure care burden

Results

Significant differences (p < 0.01) were reported in quality of patient care in the home, palliative care unit, and hospital, with highest quality of care in the home. Overall, quality of care improved significantly (p = 0.04) from preintervention to postintervention in hospitals. Similar improvements at a significant level (p = 0.012) occurred in the quality of death and dying in hospitals, although this place had the lowest score at baseline compared to palliative care units and the home. No significant differences in patient pain relief occurred pre- and postintervention, nor did caregiver burden significantly increase postintervention in any of the three settings of patient death. Quality of care measures in the hospital and in some measure domains in the palliative care unit increased significantly postintervention (p < 0.05).

Conclusions

Caregiver quantitative feedback postintervention showed the most improvement in quality of care and of death and dying in hospitalized patients, with additional improvement in palliative care units deemed as high quality by caregivers preintervention. Caregivers consistently viewed home care as highest in quality pre- and postintervention. Family burden of care did not increase in the three settings related to the intervention. With most patient deaths in hospitals in Japan and many countries, additional efforts to improve hospital quality of care may smooth the transition of dying patients to their homes for improved family well-being.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • Findings not generalizable
  • Only definition of patient status was “terminally ill”
  • Caregivers required to provide data in retrospective manner when recall may have been difficult
  • Response rate of three groups differed to affect measurement of quality of care and quality of patient death and dying.
  • Definition of family caregiver unclear in article (more than 92% of caregivers were spouses or children of the patient)
  • Significant differences in age of patients and caregivers existed in preintervention and postintervention groups, and similar significance existed in place of death in both groups.
  • Specifics of intervention unclear because of earlier publication of that information

Nursing Implications

Current emphasis on the delivery of high quality care to patients and their families in a variety of end-of-life settings mandates nursing attention to the feedback of patients who are terminally ill and their caregivers to meet that goal. Additional research and evidence from clinical practice offer opportunities to gain that feedback to improve care at the end of life for patients with cancer and their families.

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Maeda, Y., Ohune, T., Nakamura, M., Yamasaki, M., Kiribayashi, Y., & Murakami, T. (2004). Prevention of irinotecan-induced diarrhoea by oral carbonaceous adsorbent (Kremezin) in cancer patients. Oncology Reports, 12(3), 581–585.

Study Purpose

To examine the effectiveness of two interventions, AST-120 and oral alkalization, to ameliorate diarrhea after treatment with irinotecan

Intervention Characteristics/Basic Study Process

  • Patients with varying cancers who were receiving irinotecan were given AST-120, oral alkalization, or nothing (control).
  • AST-120 (Kremezin™) is an oral adsorbent made of activated carbon. Patients received 2 g at the start of irinotecan infusion, immediately after irinotecan infusion, and three hours after irinotecan infusion.
  • Oral alkalization, consisting of 2 g NaHCO3 (sodium bicarbonate), 2 g magnesium oxide, and 300 mg ursodexycholic acid, was given before irinotecan and then daily for three days after irinotecan administration.

Sample Characteristics

The study reported on 13 Japanese patients with cancer receiving 60–100 mg/m2 irinotecan every 1–2 weeks, alone or as part of a combination regimen. The control group consisted of 7 patients, the AST-120 group consisted of 4 patients, and the oral alkalization group consisted of 4 patients. One patient in each of the two intervention groups served as his or her own control, having received prior irinotecan with no prophylaxis.

Study Design

This was a nonrandomized trial.

Measurement Instruments/Methods

Patients recorded the number of bowel movements but not the volume.

Results

  • Oral alkalization appeared to be effective in ameliorating diarrhea, although the efficiency did not reach a significant difference (level of significance not indicated).
  • AST-120 significantly decreased the maximum number of daily bowel movements during irinotecan treatments as compared with no prophylaxis (p < 0.05).

Limitations

  • This was a small study with only 13 patients.
  • One patient in the AST-120 group and one patient in the oral alkalization group acted as his or her own control. Only three other patients were in each interventional treatment group.

Nursing Implications

Although further study is necessary regarding the effect of oral AST-120 on plasma concentrations of irinotecan-related compounds, it is speculated that the absorption of irinotecan or SN-38 from the intestinal lumen is small, if any, and the remaining irinotecan-related compounds in the intestinal lumen cause diffuse mucosal damage in irinotecan treatments.

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Maeda, Y., Ohune, T., Nakamura, M., Yamasaki, M., Kiribayashi, Y., & Murakami, T. (2004). Prevention of irinotecan-induced diarrhoea by oral carbonaceous adsorbent (Kremezin) in cancer patients. Oncology Reports, 12(3), 581–585.

Study Purpose

To examine the effectiveness of two interventions to ameliorate diarrhea after treatment with irinotecan

  • 2 g AST-120 (Kremezin™) oral adsorbent made of activated carbon given at the start of irinotecan infusion, immediately after irinotecan, and 3 hours later
  • An oral alkalization made of 2 g NaHCO3 (sodium bicarbonate), 2 g magnesium oxide, and 300 mg ursodeoxycholic acid given orally before irinotecan infusion and then every day for three days after

Sample Characteristics

This was a nonrandomized trial of 13 Japanese patients with various cancers receiving 60–100 mg/m2 irinotecan every one to two weeks, alone or in combination regimens. Patients received one of three interventions. Four patients received AST-120; one of these four had previously received irinotecan with no prophylaxis and thus served as a control. Four patients received the oral alkalization; one of these also had previously received irinotecan with no prophylaxis and thus served as a control. Including these two controls, a total of seven control patients received irinotecan with no prophylaxis.

Measurement Instruments/Methods

The number of bowel movements was recorded; however, volume was not recorded.

Results

Oral AST-120 was associated with significantly decreased numbers of daily bowel movements during irinotecan treatment compared to no prophylaxis (p < 0.05). Oral alkalization was effective in ameliorating diarrhea, but the difference was not significant.

Limitations

  • The sample size was very small with only 13 patients.
  • One patient in the AST-120 group and one in the oral alkalization group acted as their own controls. Only three other patients were in each interventional treatment  group.
  • Although further study is necessary regarding the effectiveness of oral AST-120 on plasma concentrations of irinotecan-related compounds, the absorption of irinotecan or SN-38 from the intestinal lumen is small, if any, and the remaining irinotecan-related compounds in the intestinal lumen cause diffuse mucosal damage in irinotecan treatments.
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Madsen, M.T., Hansen, M.V., Andersen, L.T., Hageman, I., Rasmussen, L.S., Bokmand, S., . . . Gogenur, I. (2015). Effect of melatonin on sleep in the perioperative period after breast cancer surgery: A randomized, double-blind, placebo-controlled trial. Journal of Clinical Sleep Medicine, 12, 225–233. 

Study Purpose

To conduct a secondary data analysis from the MELODY trial to determine if 6 mg of oral melatonin administered at bedtime pre- and postsurgery would improve objective and subjective sleep outcomes in patients with breast cancer

Intervention Characteristics/Basic Study Process

The original study design was a randomized, double-blind, placebo-controlled trial to test the effect of melatonin on depressive symptoms. Participants randomized to melatonin or placebo taken at bedtime for three days prior to surgery and continued until 12 weeks postoperative. Secondary data points for sleep are described in this article. No baseline sleep assessment was reported, and time points of subjective and objective data collection were preoperative night 2/3, preoperative night 1, postoperative night 1/2/3, postoperative night 4/5/6, and night before histology information, normally two weeks postoperative.

Sample Characteristics

  • N = 48  
  • MEAN AGE = 55 years
  • AGE RANGE = 34–74 years 
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Nonmetastatic breast cancer 
  • OTHER KEY SAMPLE CHARACTERISTICS: All participants were surgical patients scheduled for mastectomy or lumpectomy with sentinel node dissection with and without axillary dissection.

Setting

  • SITE: Single site    
  • SETTING TYPE: Not specified    
  • LOCATION: Herlev Hospital, Copenhagen, Denmark

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Secondary analysis of effect of melatonin on subjective and objective sleep  pre- and postsurgery

Measurement Instruments/Methods

Subjective measures included visual analog scale for subjective sleep quality (0 mm = best possible sleep and 100 mm = worst sleep). The Karolinska sleepiness scale (KS) was used to assess level of sleepiness using nine-point scale (1 = very alert, 10 = very sleepy). No psychometric properties were provided. Objective sleep actigraphy data were guided with a sleep diary for parameters of efficiency, time in bed, total sleep time, wake after sleep onset (WASO), latency, and awakenings. Actigraphy was recorded for the entire study period.

Results

Evaluation of objective sleep outcomes from actigraphy revealed no significant differences for preoperative sleep or wake outcome variables postoperatively and prehistology. Sleep efficiency was higher in the treatment group (p < 0.03). WASO was significantly lower in the postoperative times of 1/2/3 and 4/5/6 in the melatonin group (p < 0.03). No significant differences were found in the subjective measurements (sleep, pain, KSS) preoperatively and postoperatively.

Conclusions

Use of oral 6 mg of melatonin one hour before bed significantly increased efficiency in the three postoperative time points, and WASO decreased during the postoperative time points. However, subjective sleep and pain did not improve. Melatonin use needs to be further evaluated as this study had several limitations.

Limitations

  • Small sample (less than 100)
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Questionable protocol fidelity
  • Subject withdrawals of 10% or greater
  • Appropriateness of study statistical plan is questionable.
  • The active and placebo groups differed on the duration of surgery and anesthesia; since one of the three-day sleep periods included postoperative nights one, two, and three, the duration of anesthesia may have affected sleep and other outcomes in the first postoperative night, which should have been accounted for or addressed in the Limitations section.
  • The rationale for 6 mg dose is missing.
 

 

Nursing Implications

Nurses need to inquire about pre- and postoperative use of any medications to understand and counsel patients and family members on evidence that would support the use of the medication. Melatonin may be helpful to improve sleep, but additional studies are needed.

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Maddocks-Jennings, W., Wilkinson, J. M., Cavanagh, H. M., & Shillington, D. (2009). Evaluating the effects of the essential oils leptospermum scoparium (manuka) and kunzea ericoides (kanuka) on radiotherapy induced mucositis: A randomized, placebo controlled feasibility study. European Journal of Oncology Nursing: The Official Journal of European Oncology Nursing Society, 13(2), 87-93. doi:10.1016/j.ejon.2009.01.002

Study Purpose

Determine the effect of essential oil mouth rinse on mucositis onset, pain, and oral symptoms; weight loss

Intervention Characteristics/Basic Study Process

Patients were randomized to treatment, placebo, and control groups. Placebo and intervention groups were given solutions in 25 mL amber bottles with dropper caps. Patients in the treatment group were provided with a 1:1 mix of manuka and kanuka oils; placebo was sterile water. The participants further diluted and gargled for at least 15 seconds, then spit out. Then a fresh prep of same dilution was swallowed. This was started two days before radiation treatment began, and continued until one week after the completion of radiotherapy. Patients were to gargle 30 minutes either before or after eating, smoking,or drinking and before and after each radiotherapy treatment. Control patients did usual care.

Sample Characteristics

The sample was comprised of 19 patients. Intervention n = 6, placebo n = 6, control n = 7. The mean age was 68.9, with a range of 45-81 years. Females active = 1; placebo = 4, males active = 5, placebo = 2, control = 7.

Diagnosis Information: all head and neck cancer; all undergoing non-palliative radiotherapy to the oropharyngeal area.

Other Key Characteristics: Mean radiation dose across groups ranged from 5933-6200 cGy.

Setting

Single site: Outpatient setting New Zealand; large center with 7-9% of new patients with head and neck dx/year

Study Design

Randomized placebo double-blind controlled trial

Measurement Instruments/Methods

Patient diary: pain score, medication use, oral symptoms, 10 point visual analogue score (pain) RTOG 0-4 scale; body weight post-discharge survey (dry mouth/cough; altered taste and appetite; excess secretion/nausea and vomiting rating on scale of 0-10)

Results

All patients developed some mucositis. The active gargle group went the longest time before a reaction occurred (p = 0.05). Onset of pain was reported to be delayed in the treatment group; only 1% of patients had a weight decrease in the treatment group compared to a 5.2% loss in the control group and a 4.1% loss in the placebo group.

Conclusions

Because this was a feasibility study, there is no statistical analysis of the results. The results support the hypothesis that these oils may provide a positive effect on the development of mucositis, pain, and nutritional outcomes.

Limitations

Small sample <30. Need for participants to adhere to gargling; frequent performance of intervention; multiple clinicians evaluated mucositis.

Nursing Implications

Further research is needed to determine the overall benefit of this intervention.

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Madan, P.D., Sequeira, P.S., Shenoy, K., & Shetty, J. (2008). The effect of three mouthwashes on radiation-induced oral mucositis in patients with head and neck malignancies: A randomized control trial. Journal of Cancer Research Therapies, 4(1), 3–8.

Intervention Characteristics/Basic Study Process

The effect of three test mouthwashes and a control were studied.

1. 0.12% chlorhexidine
2. 1% povidone-iodine
3. salt/sodium bicarbonate
4. plain water (control)

Coloring agents, sweeteners, and flavoring agents were added to the mouthwashes so that all had identical color and taste. All were alcohol free.

Patients rinsed mouths with 10 ml of mouthwash BID for six weeks. Patients swished for about two minutes and expectorated, then abstained from eating or gargling for 30 minutes.
 

Sample Characteristics

The study was comprised of 20 patients in each arm of study.

Adult patients with stage II–IV head and neck malignancy scheduled to receive RT of 60 Gy or higher, delivered in 30 fractions over a six-week period.

At least one-third of oral cavity mucosa was included in the radiation field.

Powered for 20 subjects in each arm; 76 completed.

The median age was 54.25–58.2 years.

More men participated than women.
 

Setting

July 2003–January 2004

Study Design

Double-blind, placebo-controlled, randomized clinical trial

Measurement Instruments/Methods

Compliance was assessed weekly by checking the level of mouthwash left in bottles.

Mucositis WHO– single examiner

Primary endpoint of study was the end of week 6.
 

Results

Significant difference in mean mucositis scores was observed among all four groups. Post hoc analysis for repeated measure showed a statistically significant difference between the povidone group and control group (p = 0.013) at the end of week 1.

At the end of week 2, povidone, chlorhexidine, and salt/soda groups differed significantly from the control group.

At the end of week 4, significant differences also were observed between the povidone and salt/soda groups (p = 0.16).

At the end of week 5, significant differences were observed between all test groups and the control group. Differences also were observed within test groups.

At the end of week 6, a slightly different trend was observed. Significant differences were observed between the povidone group and all other groups; difference in mucositis among other groups was not statistically significant.
 

Limitations

Although the volume of solution used was checked weekly, data does not indicate compliance.

No data is available regarding treatment delay.
 

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Macmillan, M.S., Wells, M., MacBride, S., Raab, G.M., Munro, A., & MacDougall, H. (2007). Randomized comparison of dry dressings versus hydrogel in management of radiation induced moist desquamation. International Journal of Radiation Oncology, Biology, Physics, 68, 864–872.

Study Purpose

To evaluate the effect of a hydrogel or dry dressing on the time to healing of moist desquamation after radiation therapy

Intervention Characteristics/Basic Study Process

Participants were randomly assigned to either dry dressing or no dressing (Tricotex) or hydrogel (intrasite) dispenser at the beginning of radiation therapy. Patients received the same instruction of skin care and were provided with simple soap. Patients were instructed to use their dressing from the onset of moist desquamation, if it occurred.

Sample Characteristics

  • The study sample (N = 100) was comprised of male (n = 30) and female (n = 70) patients with breast (n = 10), head and neck (n =30), or anorectal cancer (n = 60) who developed moist desquamation.
  • Most patients were aged less than 50 years in the hydrogel (55%) and dry dressing (50%) groups.
  • Patients with breast cancer had a tangential field separation of greater than 22 cm.
  • Patients were excluded if they had a previous skin reaction to chemotherapy.

Setting

The study took place at multiple sites in Scotland.

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • Patient perception was measured completing daily diary cards that detailed the degree to which they experience pain, itching, burning, and sleep disturbances.
  • Participants rated the appearance of their skin reaction using a desquamation scale that allowed them to score whether their skin was dry or scaly, broken, or weeping in small or large patches.
  • Researchers used a modified Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer (RTOG/EORTC) scale weekly until the skin was healed.

Results

  • Moist desquamation occurred in 48% of all radiation therapy patients and reviewed mean time was 32 days, with a range of 16–50 days.
  • The reaction occurred in 47% of patients before the end of treatment and 39% during the final week. In 38%, the reaction occurred after the end of treatment.
  • Moist desquamation was confirmed earlier to those randomized to hydrogel dressings.
  • Desquamation scores improved more in patients not assigned to hydrogel dressings.
  • Skin reactions healed much more slowly in those assigned to hydrogel dressings (p = 0.03)
  • In anorectal cancer cases researcher and patient scores showed they experienced more severe reactions than the other groups and both reactions were significantly worse for those who used hydrogel than those who were assigned to the dry dressing.
  • Although variables such as body mass index and smoking, concurrent chemotherapy, bolus use, and total radiation dose were predictive of development of moist desquamation, these variables did not influence demonstrated time to healing.

Conclusions

The study does not support the routine use of hydrogel in the care of patients with moist desquamation and suggests that the healing times are prolonged, without any improvement in patient comfort.

Limitations

  • Hydrogel dressing was more costly than the dry dressing.
  • Modified RTOG/EORTC scale was not an established measure and precludes comparison to other studies.
  • Patient self-rating scales were not fully described.
  • The sample size for head and neck and breast cancer cases was small.
  • Although 100 cases were reviewed, only 48% actually would have used the assigned treatment.
  • The control group combined dry or no dressing.
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Macleod, N., Price, A., O'Rourke, N., Fallon, M., & Laird, B. (2014). Radiotherapy for the treatment of pain in malignant pleural mesothelioma: A systematic review. Lung Cancer (Amsterdam, Netherlands), 83, 133–138. 

Purpose

STUDY PURPOSE: To examine the evidence for the use of radiotherapy to treat pain in malignant pleural mesothelioma
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, and Cochrane Library
 
KEYWORDS: Detailed search terms per database are reported
 
INCLUSION CRITERIA: Malignant pleural mesothelioma diagnosed histologically or radiologically; radiotherapy given for the purpose of treatment of pain; response rates reported; documentation of dose and fractionation given; English language
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,480
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Not described, though levels of evidence reported

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 8
  • TOTAL PATIENTS INCLUDED IN REVIEW = 444
  • SAMPLE RANGE ACROSS STUDIES: 19–189 patients

 

Phase of Care and Clinical Applications

PHASE OF CARE: Late-effects and survivorship
 
APPLICATIONS: Palliative care

Results

All of the evidence was reported as low with levels of 3 or 2 (specific grading scale not described). Response rates varied from 0%–69%. Six of the studies included were retrospective case series. Two studies did not document pain, and three studies did not use any clear measure of pain.

Conclusions

The effectiveness of radiotherapy for pain palliation in this group of patients is unclear.

Limitations

  • Relatively few studies
  • Low-level evidence due to study design issues

Nursing Implications

Evidence regarding the effectiveness of radiotherapy for the treatment of pain from malignant pleural mesothelioma is lacking. Further well-designed research using valid tools for pain measurement is needed.

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Machado Rocha, F.C., Stefano, S.C., De Cassia Haiek, R., Rosa Oliveira, L.M., & Da Silveira, D.X. (2008). Therapeutic use of cannabis sativa on chemotherapy-induced nausea and vomiting among cancer patients: Systematic review and meta-analysis. European Journal of Cancer Care, 17, 431–443.

Purpose

To use a systematic literature review and meta-analysis to evaluate interventions using Cannabis sativa in the treatment of chemotherapy-related nausea and vomiting

Search Strategy

Databases searched were MEDLINE, Embase, PsycINFO, LILACS, and the Cochrane Collaboration Controlled Trials Register (12-2006).

Searched keywords were Medical Search Headings (MeSH) therapeutics, drug therapy, chemical and pharmacologic phenomena, neoplasms, antineoplastic and immunosuppressive therapy, marijuana abuse, cannabis, randomized controlled trials, and clinical trials.

Studies were included in the review if they

  • Were randomized clinical trials (RCTs).
  • Involved people with any type of cancer receiving chemotherapeutic treatment of low-, moderate-, or high-emetic potential.
  • Were published in peer-reviewed journals.
  • Evaluated pharmacologic interventions based on substances derived from Cannabis sativa or smoked Cannabis.

Studies were excluded from the review if they involved patients receiving radiotherapy.

Literature Evaluated

The initial search yielded 12,749 papers. After scanning titles for inclusion, 735 abstracts were evaluated. Of these, 96 papers were reviewed and a final sample of 30 RCTs were included in the review.  RCTs that were appropriate for meta-analysis numbered 13. Studies were rated for quality using the Cochrane Manual for methodological quality evaluation in terms of bias risk.

Sample Characteristics

  • A final sample of 30 studies was included in the systematic review, and 13 studies were included in meta-analysis.
  • Sample sizes varied among studies, with only six studies involving more than 100 patients.
  • Across studies, the total sample size was 1,719.

Results

  • Two studies comparing dronabinol to placebo showed a trend favoring dronabinol, but it was not significant (p = 0.10).
  • In five studies comparing dronabinol to neuroleptics, dronabinol was significantly better than the comparisons (relative response [RR] = 0.67, p = 0.03).
  • In six studies comparing nabilone to neuroleptics, no significant differences were found.
  • Four studies comparing levonantradol to neuroleptics showed no differences.
  • In 18 studies composed of 1,138 patients, participants had a significant preference for cannabis (RR = 0.33, p < 0.00001).
  • All of the studies had low or only moderate risk of bias.
  • Patients taking cannabinols had a higher number of collateral effects and tended to have higher symptom intensity.

Conclusions

  • Most patients preferred cannabis-based treatment when asked about their preferred drug.
  • Different cannabis derivatives demonstrated different effectiveness when compared to standard treatment used at the time.
  • Newer and more effective approaches for management of nausea and vomiting have emerged in practice since these studies were conducted.
  • Comparative effectiveness of cannabis derivatives versus these approaches is unknown.

Nursing Implications

  • If patients do not respond to antiemetics or they experience increased emesis after taking antiemetics, increased dosage or frequency of administration is not recommended.
  • Because cannabinoids appear to act through different mechanisms than other drugs, they may be effective for people with nausea and vomiting that does not respond to other management approaches. 
  • Clinical trials comparing cannabinoids to modern antiemetics are warranted.
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MacGregor, C.A., Canney, P.A., Patterson, G., McDonald, R., & Paul, J. (2005). A randomised double-blind controlled trial of oral soy supplements versus placebo for treatment of menopausal symptoms in patients with early breast cancer. European Journal of Cancer, 41, 708–714.

Study Purpose

The study looked at soy supplements versus placebo for treatment of menopausal symptoms in participants with early breast cancer and hot flashes.

Intervention Characteristics/Basic Study Process

Participants were randomized to receive either two soy capsules or two identical placebo capsules twice daily for 12 weeks in a double-blind fashion. The soy capsules each contained 235 mg of soy extract with 17.5 mg of isoflavones. Total dose of isoflavones was 70 mg/day. 

Sample Characteristics

Seventy-two (72) participants with early breast cancer and hot flashes were randomized to 12 weeks of treatment with soy capsules or with placebo. To be considered a worthwhile treatment strategy, soy extract would need to benefit around half of the participants treated. Thus, 32 evaluable participants per arm were needed.  The median age was 51 years. Any concomitant medications for preexisting disease were allowed.

Study Design

The randomized double-blind controlled trial was stratified for initial sweating/flushing score (< 2, p = 2); age at randomization (younger than 50 years, older than 50 years); currently having adjuvant tamoxifen or after ovarian suppression (yes or no).

Measurement Instruments/Methods

QOL and menopausal symptoms scores were assessed at baseline and weeks 4, 8, and 12. A four-question menopausal scale was developed for the study to assess control of menopausal symptoms measured by combined estimates of severity of sweats (day or night) and flushes.

Results

There was no significant difference in menopausal symptoms between the placebo and soy capsule arms of the study.Toxicity was mild and primarily gastrointestinal. There was no significant difference in toxicity between the 2 arms.

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