Lopez, A.P., i Figuls, M.R., Cuchi, G.U., Berenstein, E.G., Pasies, B.A., Alegre, M.B., & Herdman, M. (2004). Systematic review of megestrol acetate in the treatment of anorexia-cachexia syndrome. Journal of Pain and Symptom Management, 27, 360–369.
To assess the efficacy and safety of megestrol acetate in improving appetite, weight gain, and health-related quality of life in patients with anorexia-cachexia syndrome who had advanced cancer, AIDS, or other underlying pathologies. Other aims were to evaluate the efficacy of different doses and the safety of megestrol acetate.
The following databases were searched: Cochrane Collaboration, Cochrane Controlled Trials Register, MEDLINE, and Embase. A hand search of reference lists was completed. The keywords used were randomized controlled clinical trial, double-blind, single-blind, megestrol acetate, terminally ill, terminal care, and wasting syndrome. Variants of megestrol acetate were also keywords. There was no language restriction. Data were extracted by two reviewers who used the Jadad scale to assess quality. A third reviewer participated if needed.
Of the 296 studies identified, 26 published between 1980 and 2002 met the inclusion criteria. Of these, 19 compared megestrol acetate to a placebo, 6 compared megestrol acetate to other drugs, and 6 studied the effectiveness of different dose levels. The quality of the studies was rated on the Jadad scale: 10 were high-quality, 7 were medium-quality, and 9 were low-quality.
A meta-analysis of the studies assessing appetite had homogeneous results, showing statistically significant improvement with megestrol acetate over the placebo (RR = 2.33, 95% CI 1.52–3.59)
For weight gain, results were homogeneous and in favor of megestrol acetate, but not statistically significant (RR = 1.88, 95% CI 1.43–2.47).
For quality of life, there was significant heterogeneity because of the variety of instruments used. When the results using only the Karnofsky Performance Status Scale were analyzed, heterogeneity was not observed, and the results were positive in favor of megestrol acetate (RR = 1.64, 95% CI 1.06–2.55). Subgroup analysis in patients with cancer showed positive results in favor of megestrol acetate over placebo on appetite (RR = 2.33, 95% CI 1.52–3.59), weight gain (RR = 2.16, 95% CI 1.45–3.21), and quality of life (RR = 1.81, 95% CI 1.13–2.89).
In comparing megestrol acetate to other drugs, it showed benefit in terms of weight gain. No difference was noted between megestrol acetate and other drugs in terms of quality of life. For appetite, megestrol acetate was superior to dronabinol, but showed no advantage to other drugs studied.
In comparing the efficacy of different megestrol acetate doses, the only statistically significant result was observed in patients with cancer, for whom higher doses were associated with greater weight gain (RR = 1.65, 95% CI 1.00–2.73). There were no statistically significant differences between treatment and placebo groups in terms of adverse events, excepting edema, which was greater in the megestrol acetate group (RR = 1.67, 95% CI 1.22–2.28).
When compared with a placebo, there were significant improvements in appetite and weight gain in patients with cancer who were treated with megestrol acetate. This meta-analysis confirms the results of earlier systematic reviews that demonstrated megestrol acetate's advantages over placebo in terms of weight gain and improved appetite. This review did not define the optimal dose of megestrol acete.
Given the adverse events profile, megestrol acetate is a safe treatment option.
Loo, W. T., Jin, L. J., Chow, L. W., Cheung, M. N., & Wang, M. (2010). Rhodiola algida improves chemotherapy-induced oral mucositis in breast cancer patients. Expert Opinion on Investigational Drugs, 19 Suppl. 1, S91-100.
Investigate Rhodiola algida on healthy human lymphocytes in vitro and on the healing time of oral ulcers in breast cancer
Secondary aim: Animal study portion
In the test group, the patients consumed 200 mL boiled Rhodiola algida at a concentration of 50 mg/ml for seven consecutive days after receiving chemotherapy. Control patients were given honey bee water. All patients were given 0.2% chlorhexidine mouthwash. Rhodiola algida is a Tibetan plant used in traditional Chinese medicine, believed to affect the immune system by nourishing Chi.
The study was comprised of 130 patients, age 24-58, with a mean age of 48.5 years.
Females: 100%
Diagnosis information: Invasive ductal carcinoma
Single site: University of Hong Kong
Control trial- not clear if it was random nor blind.
Oral Mucositis Assessment Scale (OMAS) Numeric Rating Scale for pain
There were three ulcers in the treatment group and five in the control group. The diameter of ulcers in the treatment group was smaller than those in the control group. The treatment group had less pain, shorter duration of ulceration, and better body weight maintenance than the control group, all of these parameters had statistical significance (p < 0.05). Findings related to measures of immune function are provided. The WBC count in the treatment group was 5.3 (±1.02) compared to 3.2 (±0.82) in the control group. This effect may have implications for other symptoms in addition to mucositis.
Although this study showed some improvement in oral healing and pain, this group of patients does not typically experience severe mucositis.
Breast cancer only, very few episodes of mucositis to measure effectiveness; nausea and vomiting in this population may affect weight loss.
Many other potential effects of this agent. Further research with this agent would be useful.
Longo, F., Mansueto, G., Lapadula, V., DeSanctis, R., Quadrini, S., Grande, R., … DiSeri, M. (2011). Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy. Supportive Care in Cancer, 19, 1159-1164.
To evaluate the efficacy of a regimen of three-day aprepitant, a single dose of palonosetron, and three-day dexamethasone in patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC)
Patients were given the following regimen. On day 1, patients were given 0.25 mg IV palonosetron, 20 mg IV dexamethasone, and 125 mg oral aprepitant before chemotherapy; on day 2, they received 80 mg oral aprepitant and 4 mg oral or intramuscular dexamethasone; and on day 3, they were given 80 mg oral aprepitant and 4 mg oral or intramuscular dexamethasone.
Rescue therapy was 10 mg metoclopramide and 4 mg dexamethasone. Patient diaries were used to record emesis, use of rescue medication, and severity of nausea for 5 days after chemotherapy.
The study was conducted in multiple outpatient settings in Italy.
All patients were in active treatment.
This was a prospective trial.
Palonosetron in combination with aprepitant and dexamethasone was found to be effective in preventing acute and delayed nausea and vomiting with HEC.
The findings confirmed the efficacy of palonosetron as part of an antiemetic drug regimen for patients receiving HEC.
Longo, F., Mansueto, G., Lapadula, V., Stumbo, L., DelBene, G., Adua, D., … Quadrini, S. (2012). Combination of aprepitant, palonosetron and dexamethasone as antiemetic prophylaxis in lung cancer patients receiving multiple cycles of cisplatin-based chemotherapy. International Journal of Clinical Practice, 66, 753-757.
To evaluate whether the antiemetic efficacy of triple combination aprepitant, palonosetron, and dexamethasone could be sustained for up to six cycles of highly emetogenic chemotherapy (HEC) (cisplatin ≥ 50 mg/m2)
To be eligible, patients had to be chemotherapy-naïve adults with lung cancer, have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0–2, and be receiving 4–6 cycles platinum-based therapy (cisplatin ≥ 50 mg/m2).
All eligible patients received 125 mg oral aprepitant, 0.25 mg IV palonosetron, and 20 mg IV dexamethasone before chemotherapy on day 1, and 80 mg oral aprepitant and 4 mg oral or intramuscular dexamethasone on days 2 and 3. Patients recorded all vomiting episodes, any use of rescue medication, and the severity of nausea on 4-point Likert-type scale in diaries for 5 days (0–120 hours) after chemotherapy during all planned cycles.
The study was conducted at multiple outpatient sites in Italy.
All patients were in active antitumor treatment.
This was a prospective observational study.
The triple combination of aprepitant, palonosetron, and dexamethasone enhanced antiemetic protection during the first cycle and the efficacy was sustained for up to six cycles of cisplatin-based highly emeotgenic chemotherapy (HEC) in patients with lung cancer. The majority (84%) of patients were able to complete their planned number of chemotherapy treatment cycles.
Patients with advanced stage lung cancer treated with HEC who are given CINV prophylaxis according to accepted guidelines prior to each cycle maintain the benefit from the CINV prophylaxis through all cycles of treatment. Managing the distress caused by CINV may increase overall quality of life and is an important consideration when treating patients with palliative chemotherapy.
Lokkevik, E., Skovlund, E., Reitan, J.B., Hannisdal, E., & Tanum, G. (1996). Skin treatment with Bepanthen cream versus no cream during radiotherapy. Acta Oncologica, 35, 1021–1026.
To compare Bepanthen cream with no topical ointment
Patients used Bepanthen on one side of the treatment field and used no topical treatment on the other side. Patients were instructed to not inform the physician of which region or field received the application of the cream, and they randomized their own application. Bepanthen twice a day began on day 1 of radiation therapy. Skin assessments were performed weekly during treatment and two weeks following treatment.
The study used a quasi-experimental blinded trial design.
For both cancers, all skin reactions were more severe at completion of six weeks of radiation treatments, which was chosen as a reference point to standardize assessment data. No significant difference was observed in erythema, most desquamation, itch, or pain. No significant effect of any of the variables was found in regression analysis regarding erythema and desquamation.
Bepanthen did not provide any significant benefit.
Tissue toxicity is associated with 60-cobalt.
Loibl, S., Mueller, V., von Minckwitz, G., Conrad, B., Koehne, C.H., Kremers, S., . . . GBG/AGO/NOGGO study groups. (2011). Comparison of pegfilgrastim on day 2 vs. day 4 as primary prophylaxis of intense dose-dense chemotherapy in patients with node-positive primary breast cancer within the prospective, multi-center GAIN study (GBG 33). Supportive Care in Cancer, 19, 1789–1795.
The purpose of the study was to examine the superiority in reducing grade 4 leucopenia of pegfilgrastim given on day 4 over giving pegfilgrastim on day 2.
Patients were randomized to receive pegfilgrastim subcutaneously (6 mg) on day 2 or on day 4 in a 1:1 ratio. All sub study patients received intense dose-dense (IDD) chemotherapy consisting of epirubicin 150 mg/m2 every two weeks for three cycles, paclitaxel 225 mg/m2 every two weeks for three cycles, and cyclophosphomide 2,000 mg/m2 every two weeks for three cycles. All received prophylactic oral quinolone antibiotics.
A single-site setting in Germany
Randomized two-group trial
GAIN (German Adjuvant Intergroup Node Positive) study toxicity grading
The study failed to demonstrate that pegfilgrastim on day 4 was more efficacious than on day 2 with respect to grade 4 leucopenia. For patients receiving epirubicin overall, 11% of patients receiving day 2 dosing had an episode of grade 4 leucopenia during the first three cycles of chemotherapy, compared to 4% of those receiving CSF on day 4 (p = 0.015). There were no significant differences between groups in chemotherapy dose reductions or delays. During cyclophosphamide, significantly more infections occurred in the day 2 administration group (p = 0.035). Across the entire treatment, there were no differences between groups in febrile neutropenia, infections, and treatment alterations.
This study failed to demonstrate that administering pegfilgrastim on day 4 was more efficacious than on day 2 with respect to grade 4 leucopenia (the primary endpoint), febrile neutropenia, or infections.
No blinding
The data does not support a change in the current standard dosing schedule; however, it does suggest that administration of colony-stimulating factor on day 4 might be an appropriate alternative to day 2 dosing.
Loibl, S., Schwedler, K., von Minckwitz, G., Strohmeier, R., Mehta, K.M., & Kaufmann, M. (2007). Venlafaxine is superior to clonidine as treatment of hot flashes in breast cancer patients—A double-blind, randomized study. Annals of Oncology, 18, 689–693.
Compare venlafaxine to another nonhormonal agent in the treatment of hot flashes in patients with breast cancer
Patients were randomized to receive 0.075 mg clonidine twice daily or venlafaxine 37.5 mg twice daily for four weeks then crossover.
University hospital setting
Double-blind, randomized study
At end of week 4, the median hot flash frequency dropped by 7.6 hot flashes per day for patients receiving venlafaxine and 4.85 hot flashes for those receiving clonidine (p = .025). Nausea was significantly greater with venlafaxine compared with clonidine. Mouth dryness, constipation, and restless sleep were reported more with clonidine but the difference was not statistically significant.
Loh, J., & Gulati, A. (2015). The use of transcutaneous electrical nerve stimulation (TENS) in a major cancer center for the treatment of severe cancer-related pain and associated disability. Pain Medicine, 16, 1204–1210.
To examine the usefulness of transcutaneous electrical nerve stimulation (TENS) for cancer-related pain and functionality
Records of patients who received TENS were reviewed for data collection. High-frequency TENS was trialed. Patients who reported subjective pain relief were provided with a TENS unit and instructed to use it four to six times daily for 30–60 minutes. Prior to the trial, pain was assessed. Pain was reassessed between one and two months.
Retrospective, descriptive study
Overall, 69.7% of patients who trialed TENS reported benefits. Among those who responded to TENS (40 patients), there was an average VAS score decrease of 9.8 mm (p < 0.001).
TENS may be helpful for pain management in patients with cancer. The results from this study were inconclusive.
This study's findings regarding the efficacy of TENS for cancer-related pain treatment were not conclusive. Well-designed research evaluating its efficacy is needed so that options for improved pain management can be identified. Modalities such as TENS may be helpful adjuncts for patients who experience limited effectiveness with standard analgesics. However, good supporting evidence is needed.
Logothetis, C.J., Basch, E., Molina, A., Fizazi, K., North, S.A., Chi, K.N., . . . de Bono, J.S. (2012). Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: Exploratory analysis of data from the COU-AA-301 randomised trial. The Lancet Oncology, 13, 1210–1217.
To assess data to determine the effect of abiraterone acetate on pain and skeletal events in patients with castration-resistant prostate cancer
Patients were randomized to receive either 1 g abiraterone acetate or placebo orally once a day, along with 5 mg prednisone twice daily for 28-day cycles. Concomitant bisphosphonates were allowed during the study, if patients were already taking them or if a skeletal event indicated their use. Assessments occurred at baseline, on day 15, and on day 1 of the first 28-day cycle and during each subsequent 28-day cycle until the end of the study or treatment discontinuation.
Randomized double-blind, placebo-controlled trial
Brief Pain Inventory
Compared to placebo, abiraterone acetate and prednisone were associated with favorable effects on pain and a longer time to skeletal events in patients with metastatic castration-resistant prostate cancer.
Findings show that prednisone and abiraterone acetate appeared to improve pain control in patients with castration-resistant prostate cancer. Chronic bone-related pain can be a severe problem for late-stage patients with prostate cancer. For these patients, abiraterone acetate and prednisone can be helpful in reducing pain and delaying skeletal events.
Loerzel, V.W., Crosby, W.W., Reising, E., & Sole, M.L. (2014). Developing the Tracheostomy Care Anxiety Relief through Education and Support (T-CARES) Program. Clinical Journal of Oncology Nursing, 18, 522–527.
To evaluate the effectiveness of thee Tracheostomy Care Anxiety Relief through Education and Support (T-CARES) educational program for decreasing caregiver anxiety and increasing caregiver competence with tracheostomy suctioning
T-CARES is a one-hour course for caregivers about caring for a tracheostomy. The course is offered once a week in the hospital unit in a group setting. It involves an 18-minute video, group discussion, hands-on practice, and a return demonstration of tracheostomy care. The course covers the following topics: the introduction to airway anatomy, components of a tracheostomy tube, tracheostomy suctioning, stoma care, changing the ties securing the tracheostomy, cleaning the inner cannula, preparing for the unexpected, reinsertion of the tracheostomy tube after accidental decannulation, how to handle a mucous plug, when to call the doctor, and self-care. Evaluations were done at baseline and postintervention.
Nonexperimental, self-selected to receive the intervention pre- and post-test pilot study
Mean STAI scores dropped from 50.5 to 34.3 after the intervention (p = 0.008). All participants were able to perform nine of the 14 skills needed for tracheostomy suctioning. Course evaluations were positive.
T-CARES is an effective intervention for reducing caregiver anxiety and increasing caregiver competency of tracheostomy care.
Nurse-developed caregiver educational programs may be useful in decreasing anxiety and increasing competency for the development of new caregiver skills required for quality patient care. Additional research in this area is indicated.