Meyers, C. A., Weitzner, M. A., Valentine, A. D., & Levin, V. A. (1998). Methylphenidate therapy improves cognition, mood, and function of brain tumor patients. Journal of Clinical Oncology, 16(7), 2522–2527.
This study was conducted to test whether methylphenidate (MPH) treatment would improve neurobehavioral functioning in patients with malignant glioma.
Participants were administered 5 mg of MPH daily, increasing dosage by 5 mg twice daily until a response or dose-limiting toxicity was noted.
The study had a pre- and post-test design.
Objective improvements were observed in psychomotor speed, memory, visual-motor function, executive function, and motor speed and dexterity (all p < 0.05). Subjective improvements in improved energy, improved ability to ambulate, better concentration, and brighter mood were reported.
There was a significant improvement noted in cognition that cannot be explained by improved mood or use of glucocorticoids. The authors suggest that stimulants such MPH improve motivation and drive.
Meyer-Hamme, G., Beckmann, K., Radtke, J., Efferth, T., Greten, H.J., Rostock, M., & Schroder, S. (2013). A survey of Chinese medicinal herbal treatment for chemotherapy-induced oral mucositis. Evidence-Based Complementary and Alternative Medicine: ECAM, 2013, 284959.
PHASE OF CARE: Active treatment
All reviewed studies reported positive effects of Chinese herbal treatment for chemotherapy-induced oral mucositis.
Additional well-designed RCT studies are needed, especially to look at the mechanism of action for each herbal remedy. Due to poor design in terms of treatment and control groups, it was almost impossible to evaluate which parts of the treatment concepts are responsible for the measured effects in the reviewed trials.
Some studies used more than one herbal treatment with different routes of administration; therefore, it was difficult to determine which agent may have been more effective in treating oral mucositis. In general, most trials had a poor design.
No recommendations for use in clinical practice were made; recommendations were made for further studies. These studies could use placebo capsules or placebo liquids. It also was recommended that future studies decrease the complexity of the treatments in order to determine what treatments were effective.
Merckaert, I., Lewis, F., Delevallez, F., Herman, S., Caillier, M., Delvaux, N., . . . Razavi, D. (2016). Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: A randomized clinical trial comparing the benefits of single-component and multi-component group interventions. Psycho-Oncology. Advance online publication.
To compare the benefits of two interventions on anxiety in women after initial treatment for breast cancer
Women were randomly assigned to study groups in cohorts of 12 patients. One group received 15 sessions of a single-component support intervention, and the other received a 15-session group intervention combining support with psychoeducational interventions focusing on problem-solving skills, optimizing communications and use of personal and social resources, and self-hypnosis. Interventions were delivered in group settings by clinical psychologists following a structured manual. Sessions were audio and video recorded for use in clinical supervision as needed. Psychologists delivered only one type of intervention to avoid contamination. Study measures were obtained at baseline and after the intervention. All instruments were used with dynamic tasks through completion of the Mental Adjustment to Cancer (MAC) Scale followed by 12 minutes of self-relaxation and through completion of the Fear of Cancer Recurrence Inventory (FCRI) followed by a 12-minute guided hypnosis exercise.
PHASE OF CARE: Transition phase after active treatment
A significant group by time effect was observed in the multicomponent intervention compared to controls for state anxiety after self-relaxation (p = 0.006), for anxiety after guided hypnosis (p = 0.013), and for everyday anxiety level (p = 0.005). No differences were reported between groups in HADs scores. Anxiety and depression scores declined over time in both groups (p < 0.001). The item of psychological distress on the FCRI was reduced in both groups over time, with slightly better improvement in the multicomponent intervention group (p = 0.017).
Both supportive and multicomponent interventions were associated with a decline in anxiety and depression scores over time. The findings suggest that the multicomponent intervention was more effective in enabling women to manage their level of anxiety from triggers that could produce anxiety.
Both supportive and multicomponent psychoeducational type interventions were associated with a decline in anxiety and depression over time; however, determining if these changes were associated with the general supportive atmosphere of the group-based intervention is not possible. Anxiety has been shown to decline over time in general as well, without specific intervention. The findings suggest that the combination of self-hypnosis techniques and psychoeducation may enable individuals to manage their anxiety responses more effectively.
Mercier, J., Savard, J., & Bernard, P. (2016). Exercise interventions to improve sleep in cancer patients: A systematic review and meta-analysis. Sleep Medicine Reviews. Advance online publication.
STUDY PURPOSE: To summarize the available evidence regarding the extent to which exercise improves sleep in patients with cancer
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Multiple phases of care
Sleep outcomes improved in 10 studies (47.6%). Interventions included home-based programs, supervised exercise, or a combination of these two approaches. Aerobic and resistance exercise were employed individually or in combination. Meta-analysis of 12 randomized, controlled trials showed no significant effect of interventions compared to control groups.
Analysis showed no clear significant effects of exercise interventions on sleep outcomes among patients with cancer.
Evidence from this analysis does not show an effect of exercise interventions on sleep quality. However, a large body of evidence regarding numerous other benefits of exercise for people with cancer exists. The analysis and most research have included patients who do not necessarily have clinical insomnia, so it would not be expected that interventions would improve sleep. Future research needs to be conducted among patients with clinically relevant insomnia.
Merchant, T.E., Bosley, C., Smith, J., Baratti, P., Pritchard, D., Davis, T., . . . Xiong, X. (2007). A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients. Radiation Oncology, 2, 45.
To compare an APP-based cream and an aloe vera-based gel to determine effectiveness in preventing and treating radiation dermatitis
The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by the radiation oncologist. Follow-up examinations were done four to six weeks after completion of radiation therapy, with completion of questionnaires and photographs.
The study took place at St. Jude Children’s Research Hospital in Memphis, TN.
The study used a quasiexperimental design in which patients served as their own controls.
Some patients rated the APP cream better in terms of comfort and skin dryness. Grouped NCI CTCAE scores were supportive of APP cream (p = 0.004)
APP cream is more effective than aloe vera-based gel for prevention and treatment of radiation dermatitis.
Merchant, T. E., Bosley, C., Smith, J., Baratti, P., Pritchard, D., Davis, T., … Xiong, X. (2007). A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients. Radiation Oncology, 2, 45.
To compare an anionic polar phospholipid (APP)–based cream and an aloe vera–based gel to determine their effectiveness in preventing and treating radiodermatitis.
The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by a radiation oncologist. Follow-up examinations were done four to six weeks after the completion of radiation therapy (RT).
St. Jude Children’s Research Hospital, Memphis, Tennessee
The study used a quasiexperimental design. Patients served as their own controls.
The primary endpoint was skin care failure, which included moderate to severe dryness, pruritus, erythema, and dry desquamation. Skin comfort assessment was completed by the patient or his/her parent and consisted of 15 items on a four-level scale. Dermatologic assessment included a questionnaire of negative items and was completed by nursing staff. The National Cancer Institute (NCI) Common Terminology Criteria (CTC) for adverse events involving the skin used a grade 1 to 5 scale.
Significant differences in specific variables favoring APP cream were noted in some patients, including:
Grouped CTC scores were supportive of APP cream (p = 0.004). In comparing first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream. During RT, there was a difference in CTC scores, favoring the cream (p = 0.004).
APP cream is more effective than aloe vera–based gel for the prevention and treatment of radiodermatitis.
Mercadante, S., Porzio, G., Ferrera, P., Fulfaro, F., Aielli, F., Verna, L., . . . Mangione, S. (2008). Sustained-release oral morphine versus transdermal fentanyl and oral methadone in cancer pain management. European Journal of Pain, 12, 1040–1046.
To compare analgesic efficacy, adverse effects, need of increasing doses, and quality of life in patients with advanced cancer on morphine, fentanyl, and methadone
To compare the cost of pharmacologic pain management
Patients were randomized to morphine, fentanyl, or methadone. Morphine was offered as breakthrough pain medication at one-sixth of the equianalgesic 24-hour dose. Adjuvants were allowed. If the patient experienced poor opioid response or uncontrolled adverse events, he or she was switched to another opioid. Data were collected at weekly intervals for four weeks.
The study has clinical applicability for end-of-life and palliative care.
The study was a randomized controlled trial.
A similar number of patients in each group rotated to other opioids. There were no significant differences in the number of days to achieve dose stabilization, nor where there significant differences in the number of dose changes needed during titration. No differences existed in the PI of the three groups. OEI % was highest in the fentanyl group and significantly lower in the methadone group; 14 patients on methadone did not have a dose change, but 8 required a decrease in the dose and then a subsequent increase. There were no significant differences in quality-of-life scores between groups. Methadone was less expensive.
All three opioids were effective in controlling cancer pain in some patients. Adverse event profiles were similar. Methadone was less expensive compared to fentanyl and morphine but required clinical expertise in dosing due to the need to decrease and then increase the dose in some patients.
Long-acting morphine, fentanyl, and methadone are effective in controlling pain in advanced cancer. Methadone is an option for patients where cost is a concern, but prescribing methadone requires clinical expertise.
Mercadante, S., Porzio, G., Ferrera, P., Aielli, F., Verna, L., Tirelli, W., . . . Casuccio, A. (2009). Low doses of transdermal buprenorphine in opioid-naive patients with cancer pain: A 4-week, nonrandomized, open-label, uncontrolled observational study. Clinical Therapeutics, 31(10), 2134–2138.
To examine the effectiveness and side effects of transdermal buprenorphine in opioid-naive patients with cancer-related pain
Patients received an initial dose of transdermal buprenorphine: 17.5 mcg/hour, with patch changes every three days. For the treatment of breakthrough pain, patients received 5 mg oral morphine. Every 2–3 days, the transdermal buprenorphine dose was adjusted up to 70 mcg/hour. Each patient received adjuvant symptomatic drugs as needed. Patients were contacted weekly for adjustment of therapy. Patients completed rating scales of side effects and pain intensity at baseline, after 1 week, and at 4 weeks.
The setting type was unspecified. The site was Palermo, Italy.
Open-label observational trial
For the patients in this study, transdermal buprenorphine was effective for pain management and well tolerated.
Authors pointed out that the World Health Organization analgesic ladder suggests a dose equivalent of approximately 35 mcg/hour.
Mercadante, S., Tirelli, W., David, F., Arcara, C., Fulfaro, F., Casuccio, A., & Gebbia, V. (2010). Morphine versus oxycodone in pancreatic cancer pain: A randomized controlled study. The Clinical Journal of Pain, 26(9), 794–797.
To test the hypothesis that oxycodone has advantages over morphine in terms of efficacy and dose escalation in the treatment of pancreatic cancer pain
Patients were randomized to one of two groups: One group took 30 mg/day sustained-release morphine; the other, 20 mg/day sustained-release oxycodone. Clinicians increased doses as needed to treat pain that measured higher than 4 on a 0–10 rating scale or if the patient had more than three episodes of breakthrough pain per day. Patients in both groups used oral morphine, at one-sixth daily dose, to address breakthrough pain. Adjuvants were prescribed at the discretion of the clinician. Investigators collected data for four weeks. Patients could enter an extension phase that lasted eight weeks. Investigators followed patients in inpatient palliative care units, at home, and through outpatient care.
Randomized controlled trial
Authors noted no differences between groups in pain intensity or use of breakthrough medication. Pain decreased in both groups, in a similar pattern of decline. Dose escalation was similar in both groups. In regard to use of adjuvant pain medication, authors noted no differences between groups. Side effects were similar across groups, with the exception that patients receiving oxycodone had a greater increase in confusion over the course of eight weeks (p = 0.011). No difference in confusion was apparent between groups at any other time point.
This study revealed no differences in the analgesia and side effects associated with morphine and oxycodone, delivered according to similar dose escalation, used in the treatment of pancreatic cancer pain.
This study suggests that, over an eight-week period, morphine SR and oxycodone SR provide similar analgesia with similar side effects. Whether differences would become apparent during a longer term is unknown.
Mercadante, S., Intravaia, G., Villari, P., Ferrera, P., Riina, S., David, F., & Mangione, S. (2007). Intrathecal treatment in cancer patients unresponsive to multiple trials of systemic opioids. The Clinical Journal of Pain, 23(9), 793–798.
To evaluate patient response to a combination of opioids and local anesthetics administered intrathecally to patients with advanced cancer and to evaluate treating patients with an oral-to-intrathecal-morphine ratio of 100:1, along with required changes in dosage
A cohort of patients with the indicated inclusion criteria received an intrathecal catheter in the operating room under aseptic conditions. The catheter was tunneled subcutaneously to the anterior abdominal wall and connected to a subcutaneous port. Morphine and levobupivacaine initially were started via a syringe pump to provide an infusion rate of 2 mL/h. Levobupivacaine was started at 12.5 mg/d, and morphine rate was calculated from the patient’s daily systemic dose using an oral-intrathecal ratio of 100:1. Doses of each drug were modified as needed to acceptably control pain (about 4 out of 10 on a numeric pain scale), and patients were monitored for adverse effects. Adjuvants, including clonidine and ketamine, were administered intrathecally as necessary. Patients were discharged seven days after the port implantation and converted to a balloon-type device instead of syringe pump. The balloon-type device was changed every five days. Frequent follow-ups were completed over the phone or in person if possible. Pain and related symptoms were recorded prior to intervention; at hospital discharge; and at one-, three-, and six-month intervals, as well as at least one week prior to death.
This was a single-site study conducted at La Maddalena Cancer Center in Palermo, Italy.
This was a prospective trial.
In patients who have received multiple trials and routes of opioids, intrathecal treatment may provide rapid and long-term relief. An oral-intrathecal morphine conversion ratio of 100:1 and use of local anesthetics may be effective for pain control in highly opioid-tolerant patients with advanced cancer.
This study was able to demonstrate an effective method and ratio for administration of intrathecal opioids for pain relief in patients with advanced disease. This may provide nursing with additional knowledge regarding appropriate dosages for medication administration, opportunities to develop staff educational sessions on the use of intrathecal catheter maintenance, and educational materials for patients and caregivers. This study suggests that this approach has promise; however, shortcomings in reporting all of the reasons for discontinuation in 18% of the initial sample are problematic. Intrathecal treatment is associated with some complications and caregiving needs for monitoring complications.