Mar Fan, H.G., Clemons, M., Xu, W., Chemerynsky, I., Breunis, H., Braganza, S., & Tannock, I.F. (2008). A randomised, placebo-controlled, double-blind trial of the effects of d-methylphenidate on fatigue and cognitive dysfunction in women undergoing adjuvant chemotherapy for breast cancer. Supportive Care in Cancer, 16(6), 577–583.
To investigate the effects of dexmethylphenidate (d-MPH) on fatigue and cognitive function in women undergoing adjuvant chemotherapy for early breast cancer
Participants were randomized to a placebo group or a treatment group receiving d-MPH. The treatment group was started on 5 mg twice a day of d-MPH. If this was well-tolerated, the dose was increased one week later to 10 mg twice a day. The treatment group then continued taking d-MPH at a maximum of 10 mg twice a day until the end of the final cycle of chemotherapy. If participants did not tolerate 10 mg twice a day, the dose was reduced to 5 mg twice a day for the remainder of their treatment.
Three hospital-based outpatient clinics in Toronto, Canada
Prospective, randomized, double-blind, placebo-controlled trial
No difference was seen between groups on any of the cognitive assessments completed at baseline, end of chemotherapy, and at six-month follow-up.
The study failed to demonstrate a beneficial effect of d-MPH on either fatigue or cognitive dysfunction during adjuvant chemotherapy for breast cancer.
Mar Fan, H.G., Park, A., Xu, W., Yi, Q-L., Braganza, S., Chang, J., . . . & Tannock, I.F. (2009). The influence of erythropoietin on cognitive function in women following chemotherapy for breast cancer. Psycho-Oncology, 18(2), 156–161.
The study was conducted to investigate post-hoc the potential impact of erythropoietin on cognitive function following chemotherapy for breast cancer.
Patients were randomized when their hemoglobin (Hgb) level decreased to ≤ 12 g/dL. Depending on the remaining duration of chemotherapy, erythropoietin was administered for a period of time between 16 or 28 weeks. Patients were randomized to receive either 40,000 units of erythropoietin weekly or the standard of care.
This multi-site study took place in Canada.
The study was a randomized, controlled trial.
Participants showed no improvement in cognitive function or fatigue, as measured by the HSCS or HVLT-R. There was reported improvement in quality of life.
The study failed to demonstrate a protective effect of erythropoietin on cognitive dysfunction after chemotherapy in survivors of breast cancer.
Mao, J.J., Bowman, M.A., Xie, S.X., Bruner, D., DeMichele, A., & Farrar, J.T. (2015). Electroacupuncture versus gabapentin for hot flashes among breast cancer survivors: A randomized placebo-controlled trial. Journal of Clinical Oncology, 33, 3615–3620.
To evaluate the effects of electroacupuncture (EA) versus gabapentin (GP) for hot flashes among survivors of breast cancer, with a specific focus on the placebo, using sham acupuncture (SA) and placebo pills (PP), and monitoring nocebo effects.
By week eight, SA produced significantly greater reduction in HFCS than did PP (-2.39; 95% CI [-4.6, -0.17]). Among all treatment groups, the mean reduction of HFCS was greater in the EA group, followed by SA, GP, and PP (-7.4 vs -5.9 vs -5.2 vs -3.4; p = < 0.001). The pill groups had more treatment-related adverse effects than did the acupuncture groups; GP (39.3%), PP (20%), EA (16.7%), and SA (3.1 %), with p = 0.005. By week 24, HFCS reduction was greatest in the EA group, followed by SA, PP, and GP (-8.5 vs -6 vs -4.6 vs -2.8; p = 0.002).
EA resulted in the greatest reduction in hot flashes both at the end of the treatment and four months after the treatment. GP had similar effects while women received treatment, but not off treatment. Acupuncture (both SA and EA) elicited greater placebo and smaller nocebo effects than did GP or PPs for the management of hot flashes.
The EA group was found to have enhanced effects of reducing hot flashes in breast cancer survivors; however, SA also had better effects in reducing hot flashes than either GP or PPs. GP was associated with the most adverse effects, and the PP group reported more nocebo effects than did SA. This might be important information for nurses to be aware of as they provide education to patients.
Mao, J.J., Farrar, J.T., Bruner, D., Zee, J., Bowman, M., Seluzicki, C., . . . Xie, S.X. (2014). Electroacupuncture for fatigue, sleep, and psychological distress in breast cancer patients with aromatase inhibitor-related arthralgia: A randomized trial. Cancer, 23, 3744–3751.
To examine electroacupuncture (EA) compared to sham acupuncture (SA) and a waitlist control (WLC) group to determine effectiveness on fatigue, sleep disturbance, depression, and anxiety in postmenopausal breast cancer survivors who reported joint pain, or arthralgia, related to aromatase inhibitors (anastrazole, letrozole, exemestane)
Acupuncture interventions were administered by two licensed acupuncturists (not physicians). Ten treatments were administered over eight weeks with two treatments during each of the first two weeks followed by one treatment per week for the following six weeks. The EA and SA treatments were administered by the same two acupuncturists. Procedures for the two groups differed in the placement of the acupuncture needles and actual versus sham electrical stimulation using a transcutaneous electrical nerve stimulation (TENS) unit. The same timing and duration of treatments was used for each group.
Three-group randomized controlled trial comparing EA, SA, and WLC.
Four measurement tools were used: the Brief Pain Inventory (BPI); the Brief Fatigue Inventory (BFI); the Pittsburgh Sleep Quality Index (PSQI); and the Hospital Anxiety and Depression Scale (HADS). A priori primary outcome reported pain intensity and interference. A priori secondary outcome reported fatigue, sleep, and psychological distress (anxiety, depression).
Measurements were repeated at weeks 4, 8, and 12. There was significant (p = 0.0095) improvement in the fatigue score after EA, no improvement with SA, and greater reduction in fatigue than the WLC group. There were nonsignificant improvements in sleep in the EA and SA groups compared to the WLC group. There was significant (p = 0.04) improvement in the EA group but the SA group on the HADS anxiety score compared to the WLC group; a nonsignificant improvement continued in the EA group at week 8, whereas week 12 showed a significant (p = 0.006) improvement in the EA and WLC groups. EA and SA group improvements in depression scores were significant (p = 0.015 and p = 0.0088, respectively) compared with the WLC group; EA and SA significantly (p = 0.0031m and p = 0.0056, respectively) improved scores at week 8, and scores did not change at week 12.
EA produced improvements by reducing fatigue, anxiety, and depression scores. SA produced improvements in depression scores only. Acupuncture with electronic stimulation may be an effective treatment for pain and the nonpain symptoms of fatigue, sleep disturbance, and depression associated with AIs. Additional research is encouraged.
Acupuncture with electrical stimulation should be considered a viable treatment option for patients with breast cancer taking AIs who complain of joint pain. Large, randomized, controlled research studies are needed to develop evidence for the efficacy of EA in breast and other cancers. Drug and symptom cluster correlations must be deconstructed.
Mao, J.J., Xie, S.X., Farrar, J.T., Stricker, C.T., Bowman, M.A., Bruner, D., & DeMichele, A. (2014). A randomised trial of electro-acupuncture for arthralgia related to aromatase inhibitor use. European Journal of Cancer, 50, 267–276.
To test the hypothesis that electroacupuncture (EA) would improve function and reduce arthralgia compared to usual care
Patients were randomized to wait-list control, EA, or sham acupuncture (SA) groups. Acupuncture was given twice a week for two weeks, then weekly, for a total of 10 treatments over eight weeks. SA treatment frequency and duration were the same as for EA. Study assessments were done at baseline, after eight weeks, and at week 12.
At week 8 and week 12, the EA group had a greater reduction in pain severity and pain interference compared to the wait-list control group (p < .001). The EA group also had greater improvement in DASH scores and outcomes, as measured by the WOMAC index compared to controls. The SA group also had a significantly greater reduction in pain severity and interference compared to controls at week 8 and week 12 (p < .005). No significant differences were seen between the SA and EA groups.
EA and SA were associated with reduction in arthralgia pain severity and interference and improvement in joint disability measures.
Findings suggest that EA and placebo acupuncture resulted in reduced pain from arthralgia in patients receiving aromatase inhibitors. Although this study was well designed, the sample size was small, and a substantial number of participants dropped out. Placebo effects of acupuncture or SA may help to alleviate arthralgia pain in these patients, and this approach may be acceptable or preferred by some patients.
Mao, H., Mao, J.J., Guo, M., Cheng, K., Wei, J., Shen, X., & Shen, X. (2016). Effects of infrared laser moxibustion on cancer-related fatigue: A randomized, double-blind, placebo-controlled trial. Cancer, 122, 3667–3672.
To evaluate the safety and efficacy of laser moxibustion for cancer-related fatigue
Moxibustion is a modality of acupuncture that involves burning the herb Artemisia vulgaris on or above the skin at acupoints. This provides heat stimulation instead of stimulation by needles. Infrared laser moxibustion is an approach using laser devices to irradiate acupoints at about 2 cm away from the skin's surface. Patients were randomly assigned to receive real or sham laser moxibustion for 20 minutes three times per week for four weeks. The laser operator was blinded; because the infrared laser is colorless, neither the operator nor the patient could see it. For the sham group, the laser source was turned off. Fatigue was measured at baseline and at weeks 2, 4, and 8.
PHASE OF CARE: Multiple phases of care
Double-blind, sham-controlled, randomized, controlled trial
Brief Fatigue Inventory (BFI), Chinese version
At week 2, the fatigue score in the moxibustion group was lower (3.8 versus 4.7, Cohen’s d = 0.685, p = 0.044). At week 4, fatigue was also lower in the moxibustion group (3.01 versus 4.40, Cohen's d = 1.14, p = 0.002), and at week 8, the moxibustion group had lower fatigue as well (3.03 versus 4.26, Cohen's d = 0.886, p = 0.006). No serious adverse events were reported.
The findings suggest that laser moxibustion may be helpful in relieving cancer-related fatigue.
Laser moxibustion may be another option to combat cancer-related fatigue. This is a painless, noninvasive intervention that warrants further investigation.
de Melo Manzi, N., de Campos Pereira Silveira, R.C., & dos Reis, P.E. (2015). Prophylaxis for mucositis induced by ambulatory chemotherapy: Systematic review. Journal of Advanced Nursing, 72, 735–746.
STUDY PURPOSE: To systematically review evidence regarding interventions used to prevent chemotherapy-induced oral mucositis (OM)
PHASE OF CARE: Active antitumor treatment
Based on this review, the strongest evidence was in favor of cryotherapy in patients receiving 5-FU. The evidence was insufficient in other interventions to demonstrate a benefit.
Very few studies were included, and why this search did not yield a larger number of studies for some of these interventions was unclear. Exclusion criteria may have eliminated many. Most included studies had small sample sizes.
The findings support the use of cryotherapy for the prevention of OM in patients receiving 5-FU. Although not studied extensively, this intervention should have benefit in patients receiving any agent with a short half-life. The amount of ice chips, etc. used and the duration of the cryotherapy varied. Multinational Association of Supportive Care in Cancer guidelines recommend a 30-minute duration and an amount of ice that can easily be moved around in the mouth.
Manusirivithaya, S., Sripramote, M., Tangjitgamol, S., Sheanakul, C., Leelahakorn, S., Thavaramara, T., et al. (2004). Antiemetic effect of ginger in gynecologic oncology patients receiving cisplatin. International Journal of Gynecologic Cancer, 14, 1063-1069.
To determine the potential antiemetic effect of ginger in cisplatin-induced emesis
Patients were randomized to one of two groups. In regimen A, patients received 1 g of ginger per day for five days starting on the first day of chemotherapy. In regimen B, patients received a placebo on day one and metoclopramide on days two through five.
The study was conducted in Bangkok, Thailand.
Investigators assessed nausea and vomiting on day one. On days 2-5, patients recorded the presence and intensity of emetic episodes on diary cards.
In regimen A, no effect was found in acute or delayed treatment. In regimen B, ginger had the same control as 40 mg metoclopramide for delayed nausea.
Mantovani, G., Massa, E., Astara, G., Murgia, V., Gramignano, G., Lusso, M.R., … Maccio, A. (2003). Phase II clinical trial of local use of GM-CSF for prevention and treatment of chemotherapy and concomitant chemoradiotherapy-induced severe oral mucositis in advanced head and neck cancer patients: An evaluation of effectiveness, safety and costs. Oncology Reports, 10, 197-206.
To evaluate a granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwash in the prophylactic and curative settings of oral mucositis (OM)
All patients were given 300 mcg of granulocyte-macrophage colony-stimulating factor (GM-CSF) in 300 ml of water; patients were instructed to rinse and gargle with the mouthwash for as long as possible, three times daily (morning, midday, and before bedtime). Patients were instructed to not eat, drink, or rinse with another mouthwash for at least one hour afterward. Patients in the prophylactic group also received amifostine (500 mg IV). Patients in the curative group were treated from the appearance of mucositis until two days after clinical resolution.
This was an open, nonrandomized, phase II study.
Mantovani, G., Macciò, A., Madeddu, C., Gramignano, G., Lusso, M. R., Serpe, R., . . . Deiana, L. (2006). A phase II study with antioxidants, both in the diet and supplemented, pharmaconutritional support, progestagen, and anti-cyclooxygenase-2 showing efficacy and safety in patients with cancer-related anorexia/cachexia and oxidative stress. Cancer Epidemiology, Biomarkers and Prevention, 15, 1030–1034.
The integrated treatment consisted of the following components:
Patient outcomes were assessed at baseline and one, two, and four months.
Not identified
Patients were undergoing the active treatment phase of care.
This was an open, early-phase II study.
Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF)
Compared to baseline scores, fatigue outcomes improved at two months (p = 0.22) and more so at four months (p = 0.004). No correlation existed between changes in fatigue and changes in any other variable studied.