Bruera, E., Yennurajalingam, S., Palmer, J.L., Perez-Cruz, P.E., Frisbee-Hume, S., Allo, J.A., . . . Cohen, M.Z. (2013). Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer: A randomized, placebo-controlled, phase II trial. Journal of Clinical Oncology, 31(19), 2421–2427.
Compare the effects of methylphenidate (MP) (psychostimulant) with those of a placebo (PL) on cancer-related fatigue. The effect of a combined intervention including MP plus a nursing telephone intervention (NTI) also was assessed.
Patients with a fatigue score of greater than or equal to 4 out of 10 on the Edmonton Symptom Assessment Scale (ESAS) randomly were assigned to one of the following four groups: MP plus NTI, PL plus NTI, MP plus control telephone intervention (CTI), and PL plus CTI.
Randomized, controlled trial; placebo controlled
The groups MP alone, NTI alone, or MP plus NTI proved not significantly better than PL for cancer-related fatigue. Anxiety improved with the telephone intervention (p = .01), as did sleep (p < .001).
MP, used alone or in combination with NTI, was not superior to the control group or the PL for fatigue or depression. NTI was associated with improvement in anxiety and sleep.
Although the use of MP did not prove to be effective for cancer-related fatigue, several cancer-related symptoms significantly were improved with NTI. Further research in this area would be ideal, but NTIs remain potentially effective for patient support and education and can have a positive effect on patient experience.
Bruera, E., Sweeney, C., Willey, J., Palmer, J.L., Strasser, F., Morice, R.C., et al. (2003). Randomized controlled trial of supplemental oxygen versus air in cancer patients with dyspnea. Palliative Medicine, 17(8), 659–663.
The objective of the study is to determine the effectiveness of oxygen versus air to decrease dyspnea and fatigue and to increase distance walked during a six-minute walk test.
Oxygen or air was delivered via nasal cannula during a six-minute walk test.
The study reported on a sample of 33 patients.
The study had the following inclusion criteria.
Patients were excluded if they were on oxygen therapy.
Double-blind, randomized, controlled crossover study
Fatigue and dyspnea were evaluated by a visual analog scale (0 = absence of symptoms and 10 = worst possible symptoms). Respiratory rate and heart rate were monitored. The outcomes measured were dyspnea at three and six minutes, fatigue at six minutes, and distance walked. This was repeated when patients received the crossover treatment. Patients and researchers both rated dyspnea. Oxygen saturation was measured at baseline before the crossover and at completion of the study.
No significant differences were noted between the two groups observed. Dyspnea score at three minutes, dyspnea score at six minutes, fatigue score at six minutes, and distance in feet walked at six minutes were not statically significant (p > 0.52). The authors concluded that the routine use of supplemental oxygen for dyspnea during exercise in this patient population cannot be recommended.
Bruera, E., de Stoutz, N., Velasco-Leiva, A., Schoeller, T., & Hanson, J. (1993). Effects of oxygen on dyspnoea in hypoxaemic terminal-cancer patients. Lancet, 342(8862), 13–14.
The objective of the study is to assess oxygen therapy in patients with cancer.
Patients received two courses of oxygen at 5 L per minute and two courses of room air at 5 L per minute. Patients were randomized to either air or oxygen and then crossed over to the other treatment.
The study reported on a sample of 14 patients with hypoxemic dyspnea caused by advanced cancer previously treated with supplemental oxygen. Patients had normal cognitive function (MMSE score of at least 24/30) and hypoxemia (oxygen saturation less than 90% when patients breathed room air for more than five minutes). All were receiving oxygen via nasal cannula at 4 L per minute.
The study was a prospective, crossover, double-blind trial.
A baseline assessment occurred after 30 minutes of bed rest and a minimum of 5 minutes of stable oxygen saturation on room air. Dyspnea was assessed with VAS (0 = none to 100 = most). RR was measured for one minute twice; the results were averaged and assigned a score of 1–4 for RR. Patients made blind choices as to which treatment was most beneficial. Pulse oximetry evaluations also were recorded.
Oxygen saturation, respiratory rate and effort, and VAS were significantly better on oxygen (p < 0.0001). Researchers concluded that oxygen is beneficial to patients with hypoxia and dyspnea at rest.
Bruera, E., Sala, R., Spruyt, O., Palmer, J. L., Zhang, T., & Willey, J. (2005). Nebulized versus subcutaneous morphine for patients with cancer dyspnea: a preliminary study. Journal of Pain and Symptom Management, 29, 613–618.
To compare subcutaneous (SC) injection versus nebulized morphine (median dose of 45 mg, equal to half of the scheduled equivalent opioid dose) on two separate days; because nebulized morphine is thought to have rapid onset of action and low systemic absorption, adverse effects may be avoided.
The study used a double-blind, randomized crossover trial design.
Significant improvement occurred in dyspnea scores from baseline to 60 minutes measured at 15-minute intervals for both SC (dyspnea score decreased from 5 to 3; p = 0.025) and nebulized morphine (dyspnea score decreased from 4 to 2; p = 0.007). No significant difference was found between SC and nebulized morphine for each time period. Bronchospasm was not observed in the nebulized treatment group.
Both routes were effective in this sample. The number of patients was insufficient to determine a difference between the routes.
Bruera, E., Macmillan, K., Pither, J., & MacDonald, R.N. (1990). Effects of morphine on the dyspnea of terminal cancer patients. Journal of Pain and Symptom Management, 5(6), 341–344.
The objective of this study was to assess the effect of one dose of subcutaneous (SC) morphine on dyspnea in patients with terminal cancer.
Patients were given 2.5 times their regular dose of morphine, administered at the time of their scheduled analgesic dose. In five patients who were not receiving opioids, the dose was 5 mg of morphine. The average dose administered was 22–28 mg.
The study reported on a sample of 20 consecutive patients with terminal cancer; all patients had severe dyspnea at rest because of restrictive respiratory failure.
The study was conducted on a palliative care unit.
The study was an open, uncontrolled trial.
The study had a small sample size.
Bruera, E., Miller, M.J., Macmillan, K., & Kuehn, N. (1992). Neuropsychological effects of methylphenidate in patients receiving a continuous infusion of narcotics for cancer pain. Pain, 48(2), 163–166.
This study was conducted to assess the effects of methylphenidate (MPH) on neuropsychological functions for patients with cancer on continuous subcutaneous (SQ) infusion of narcotics for pain.
Participants were assessed immediately before and two hours after dose for two days.
The study took place at Edmonton General Hospital in Alberta, Canada.
The study was a randomized, double-blind, placebo-controlled, crossover trial.
Significant improvement was noted in drowsiness, confusion, tapping speed, arithmetic skills, reverse digits, and visual memory (p < 0.001). Patients and investigators blindly chose MPH as more effective over the placebo in 13 of 14 cases.
In patients with cancer who had significant pain, immediate improvements in alertness, attention, and memory were noted.
Bruera, E., Neumann, C.M., Pituskin, E., Calder, K., Ball, G., & Hanson, J. (1999). Thalidomide in patients with cachexia due to terminal cancer: Preliminary report. Annals of Oncology, 10, 857–859.
Patients received 100 mg of thalidomide by mouth at night for 10 days. If improvement was shown, patients could continue.
This was an open-label study.
More than 30% improvement in symptom intensity was observed in the following parameters: difficulty falling asleep (17/35 = 49%), morning restedness (23/36 = 64%), insomnia (22/32 = 69%), nausea (16/36 = 44%), appetite (22/35 = 63%), and well-being (18/34 = 53%). Twenty-seven patients completed food intake forms on days 1 and 10. Caloric intake increased from 1,325 to 1,531 calories per day (p = 0.047). Three patients discontinued thalidomide because of adverse effects: dizziness (1) and drowsiness (2).
Findings need to be confirmed in double-blind studies.
Bruera, E., Strasser, F., Palmer, J.L., Willey, J., Calder, K., Amyotte, G., & Baracos, V. (2003). Effect of fish oil on appetite and other symptoms in patients with advanced cancer and anorexia/cachexia: A double-blind, placebo-controlled study. Journal of Clinical Oncology, 21, 129–134.
To evaluate the efficacy of 1,000 mg fish oil capsules versus placebo of 1,000 mg olive oil capsules in a two-arm trial
A daily dose of 18 capsules was given over a two-week period. Dosage decreased to a minimum of six capsules daily secondary to intolerance. Mean eicosapentaenoic acid (EPA) dose was 1.8 g/day. Docosahexaenoic acid dose was 1.2 g/day.
The two-site trial was conducted in the Acute Palliative Care Unit at Grey Nuns Hospital and the inpatient and outpatient areas at Cross Cancer Institute in Edmonton, Alberta, Canada.
A randomized, placebo-controlled, double-blinded trial design was used.
Five patients in each group left the study secondary to gastrointestinal intolerance. There was no significant difference in any of the subjective or objective parameters between the two groups. Both groups showed an equal trend toward improved appetite, –9.8 for the fish oil and –9.0 for the olive oil placebo on the VAS.
Bruera, E., Roca, E., Cedaro, L., Carraro, S., & Chacon, R. (1985). Action of oral methylprednisolone in terminal cancer patients: A prospective randomized double-blind study. Cancer Treatment Reports, 69, 751–754.
To compare the effectiveness of oral methylprednisolone against placebo for relief of symptoms in patients with terminal cancer (pain, psychiatric status, appetite, nutritional status, and daily activity)
Participants were randomized to two groups, one receiving a placebo and the other receiving oral methylprednisolone (MP).
Participants were evaluated in in the morning on days 0, 5, 13, and 33.
A randomized, double-blind, crossover trial design was used.
The following symptoms were measured.
At the completion of the study, 31 participants were evaluated. They showed significant improvement in pain, depression, appetite, and food consumption. No improvement was noted in anxiety or performance status.
No change in nutritional status was observed in either arm of the study. All parameters sensitive to MP reached maximum improvement during the first phase of the study. Eight of 23 participants who initially responded to MP were not experiencing symptomatic benefit from the drug by day 33.
The study suggested that short courses of corticosteroids can be given to severely symptomatic patients with advanced cancer who have no major contraindications.
Brown, J.C., Troxel, A.B., & Schmitz, K.H. (2012). Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: Musculoskeletal injuries and health care use in a weightlifting rehabilitation rrial. The Oncologist, 17(8), 1120–1128.
To compare the risk of musculoskeletal injury in women with or at risk for lymphedema between a weight-lifting program and standard care
Women were randomized to receive twice weekly weight lifting or standard care for one year. Patients in both groups attend one hour of education on lymphedema. Women in the weight-lifting group received twice weekly group-based supervised instruction on proper biomechanics. Sessions lasted 90 minutes and included upper- and lower-body exercises and 10 minutes of aerobics and static stretching. If there were no changes in arm symptoms at a given weight, the weight was increased by 1 lb. There was no upper limit on maximum weight lifted over one year. Patients with lymphedema wore a custom-fitted compression garment during exercise. Data were compared to weight-lifting injury rate data among a general population.
The study took place in the eastern United States.
The study has clinical applicability for late effects and survivorship.
The study used a radonmized controlled trial design with epidemiological analysis comparison.
Strength was better in the weight-lifting group at 12 months compared to usual care controls (p = 0.03). Patients with lymphedema had greater odds of a musculoskeletal injury compared to controls (OR 19.9, 95% CI 5.1–77, p = 0.001). Patients at risk for lymphedema in the weight-lifting group did not have higher odds of injury. Injury rate per 1,000 reported exercise sessions among patients who did the weight-lifting was less than weight-lifting injury rates among a comparison group of premenopausal women. Six women in the weight-lifting group reported shoulder injuries, one had a wrist injury, and three had lower-body injury. Healthcare use in the control group was not reported.
Weight lifting in women with and at risk for lymphedema appears to be safe, with no more frequent injury rates than those seen in other women; however, musculoskeletal injuries did occur. This points to the need for supervision and communication with professional healthcare providers when delivering a weight-lifting program.
Findings suggest that women with or at risk for lymphedema can safely do weight lifting, although, as with women without these problems, musculoskeletal injuries can occur. It appears that shoulder injuries were most common. These results point to the importance of supervision and monitoring by appropriate professionals during any weight-lifting program.