Sprod, L.K., Fernandez, I.D., Janelsins, M.C., Peppone, L.J., Atkins, J.N., Giguere, J., . . . Mustian, K.M. (2015). Effects of yoga on cancer-related fatigue and global side-effect burden in older cancer survivors. Journal of Geriatric Oncology, 6, 8–14.
To analyze the effects of a four-week yoga intervention on cancer-related fatigue and the burden of overall side effects in older cancer survivors
This report is a secondary analysis of a previously published multi-site, randomized, controlled trial to assess the effects of yoga on fatigue and sleep problems among patients with cancer who completed initial treatment. Participants aged 60 years or older who had completed fatigue measures were included in this analysis. Group yoga sessions were provided two days per week for four weeks. The program included breathing exercises, postures, and mindfulness exercises involving meditation, visualization, and affirmation. Random sessions were independently observed by study coordinators to verify the content.
Single, blinded, randomized, controlled trial
Participants attended an average of 6.2 of the eight yoga sessions. After the intervention, yoga participants reported a significantly lower level of fatigue compared to the standard care patients (p = 0.03) and a significantly lower global side effect burden (p < 0.01). Significant results were only in the physical and mental components of fatigue.
The findings of this study showed that yoga improved fatigue.
The findings of this study suggest that yoga may be beneficial to older cancer survivors for the reduction and management of cancer-related fatigue. Studies of yoga have tended to be done in women and individuals with relatively high formal education. Additional research is needed to examine the effectiveness and acceptance of this type of intervention in more diverse patient groups.
Sprinzl, G.M., Glava, O., deVries, A., Ulmer, H., Gunkel, A.R., Lukas, P., et al. (2001). Local application of granulocyte-macrophage colony stimulating factor (GM_CSF) for the treatment of oral mucositis. European Journal of Cancer, 37, 2003-2009.
GM-CSF topically (Leukomax mouthwash)
Given in 250 ml 400 mcg recombinant Escherichia coli GMCSF once daily as soon as erythema was diagnosed, ordered to swish and swallow over period of 1 hr.
Control arm – conventional mouthwash (Hydrocortisone, Pantocain)
Patients also told to maintain strict oral hygiene using a soft toothbrush and fluoride toothpaste, and to avoid tobacco, alcoholic beverages, very hot and cold food, and spicy food.
Stratified for RT chem. Combination or RT alone.
All patients had daily rinses at least 3x/day. GM-CSF versus pantocain, hydrocortisone, cional kreussler, and bepathen (European product).
The study was comprised of 59 patients, recruited, 14 not randomized, patients = 45.
GMCSF group = 23, 21 control
18 and 17 completed trial
Jan 1997 – Oct 1998
Prospective, randomized, parallel grouped phase II clinical trial (non-blinded)
WHO scale for mucositis
No statistically significant evidence was reached in the grade of oral mucositis or the patient’s perception of oral pain.
Unable to determine therapeutic benefit of control arm product versus lack of effect of GM-CSF versus benefit of strict oral hygiene.
Authors conclude the agent cannot be recommended.
Intervention not effective
Spielberger, R., Stiff, P., Bensinger, W., Gentile, T., Weisdorf, D., Kewalramani, T., … Emmanouilides, C. (2004). Palifermin for oral mucositis after intensive therapy for hematologic cancers. New England Journal of Medicine, 351(25), 2590–2598.
IV palifermin (recombinant human keratinocyte growth factor) 60 mg/kg was given for three consecutive days immediately before a conditioning regimen (total body irradiation [TBI] plus high-dose [HD] chemo). Additional doses administered on days 0, 1, and 2.
The study was conducted in a multisite setting.
This was a placebo-controlled, double-blind, phase 3, randomized trial.
Patients in the palifermin group experienced statistically significant decreases in incidence and duration of mucositis.
Spencer, A., Horvath, N., Gibson, J., Prince, H.M., Herrmann, R., Bashford, J., … Taylor, K. (2005). Prospective randomized trial of amifostine cytoprotection in myeloma patients undergoing high-dose melphalan conditioned autologous stem cell transplantation. Bone Marrow Transplantation, 35, 971–977.
Patients in the study group received 910 mg/m2 IV amifostine 15–30 minutes prior to 200 mg/m2 melphalan prior to autotransplant for multiple myeloma (MM).
This was a multicenter study conducted between May 1999 and November 2000.
This was an open label, randomized study.
The World Health Organization (WHO) scale for mucositis, median duration of mucositis, duration of total parenteral nutrition (TPN), and duration of narcotics use were recorded.
This study provided weak statistical evidence for the use of amifostine.
Speck, R.M., Courneya, K.S., Mâsse, L.C., Duval, S., & Schmitz, K.H. (2010). An update of controlled physical activity trials in cancer survivors: A systematic review and meta-analysis. Journal of Cancer Survivorship, 4, 87–100.
PHASE OF CARE: Multiple phases of care
The majority of studies demonstrated a positive effect on upper and lower body strength and self-esteem with physical activity during treatment. The majority of studies also demonstrated a positive effect on aerobic fitness, lower body flexibility, lean body mass, quality of life, trial outcome index, breast cancer subscale, vigor and vitality, fatigue, immune parameters, pain, symptoms, and side effects post-treatment. Twenty-nine of 36 studies reporting on aerobic exercises reported no side effects from physical activity. Significant WMES were found post-treatment for fatigue (-0.54, p = 0.003).
In general, physical activity is well-tolerated during and after cancer treatment. More studies are needed on specific kinds of exercise and the structure of delivery. Physical activity studies with fatigue as an outcome have increased from five to 14 since 2005 for post-treatment interventions with 93% of studies showing positive results and 50% of them being statistically significant.
Patients can be educated that physical activity after a cancer diagnosis can be safe with modifications as necessary.
Speca, M., Carlson, L.E., Goodey, E., & Angen, M. (2000). A randomized, wait-list controlled clinical trial: The effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosomatic Medicine, 62, 613–622.
The mindfulness based stress reduction (MBSR) intervention was based on the main principle that purposeful management of awareness can be used repeatedly in the ongoing process of adapting to illness once experiential knowledge of key processes in the stress-response cycle is mastered. Objectives of program were to
The intervention consisted of seven 90-minute weekly sessions. Patient outcomes were evaluated at baseline and at week 7 (end of intervention).
The MBSR intervention did not have a significant effect on improving fatigue outcomes for patients. When comparing pre- and post-test intervention scores, both the control and intervention groups experienced a decline in fatigue scores from baseline to week 7; however, this difference did not reach significance for either group.
In the initial sample of 109 patients enrolled in the study, 19 dropped out. A dropout analysis was performed, and initial POMS scores of dropouts were found to have significantly more mood disturbance on the subscales of anxiety, depression, fatigue, and total mood disturbance (p < 0.05).
Spathis, A., Fife, K., Blackhall, F., Dutton, S., Bahadori, R., Wharton, R., . . . Wee, B. (2014). Modafinil for the treatment of fatigue in lung cancer: Results of a placebo-controlled, double-blind, randomized trial. Journal of Clinical Oncology, 32, 1882–1888.
To establish the safety and efficacy of modafinil for the treatment of fatigue in patients with non-small cell lung cancer
Patients were randomized to take either oral modafinil 100 mg or a matched placebo capsule. Patients took the medication on a fixed-dose titration schedule of one capsule daily for 14 days and then two capsules daily for the next 14 days. Assessments were done at baseline and on days 14 and 28.
Double-blinded, placebo-controlled, randomized, controlled trial
Fatigue declined in all patients with no significant differences between groups. Modafinil appeared to be well-tolerated with no difference between groups in adverse events; however, more patients in the modafinil group withdrew from the study (p = .02). 42% of those receiving modafinil and 23% of those on the placebo reported that the treatment was not helpful.
Modafinil was not shown to be effective in reducing fatigue in this study.
The findings of this study do not show the efficacy of modafinil in the treatment of cancer-related fatigue. Nurses should be aware that there is insufficient evidence to support effectiveness of modafinil for fatigue and should advocate for the use of interventions that have demonstrated effectiveness.
Spathis, A., Dhillan, R., Booden, D., Forbes, K., Vrotsou, K., & Fife, K. (2009). Modafinil for the treatment of fatigue in lung cancer: a pilot study. Palliative Medicine, 23, 325–331.
To determine the feasibility of conducting a randomized, controlled trial to assess the efficacy and safety of modafinil for the treatment of fatigue in patients with lung cancer.
Patients with non-small cell lung cancer (NSCLC) took modafinil in a fixed dose-titration schedule (100 mg daily on day 1 and increasing in the second week to 200 mg daily) for 14 days.
This was an intervention feasibility study.
It is feasible to conduct randomized, controlled trials.
The study had a small sample size, with less than 30 patients.
Spahn, G., Choi, K.E., Kennemann, C., Ludtke, R., Franken, U., Langhorst, J., . . . Dobos, G.J. (2013). Can a multimodal mind-body program enhance the treatment effects of physical activity in breast cancer survivors with chronic tumor-associated fatigue? A randomized controlled trial. Integrative Cancer Therapies, 12, 291–300.
To evaluate a multimodal mind-body program (MMMT) compared to walking effect on fatigue in women with stage I–IIIA breast cancer
Participants in the intervention group underwent six hours of training in meditation, whole-food cooking, naturopathic strategies, and mindfulness by a multidisciplinary team. A sports therapist supervised a walking program in weeks 1, 3, and 10. Participants were encouraged to walk at home three times per week for 30 minutes. Participants in the control group also underwent a sports therapist-supervised walking program in weeks 1, 3, and 10. They also were encouraged to walk at home three times per week for 30 minutes.
Unusual fatigue in the last week and last month was improved in both groups with no group differences. Anxiety in the MMMT group was improved compared to the control group (p = .043) during treatment but was not maintained in follow-up (p = .422). Both groups showed overall anxiety improvement. Reported pain between groups was improved in MMMT at follow-up compared to control (p = .031). Menopausal symptoms decreased in both groups. No significant side effects were seen.
A home-based exercise program showed improvement in reported fatigue. The addition of a mind-body component showed no additional benefit.
Home-based exercise is a reasonable and safe option for patients experiencing cancer-related fatigue.
Sorooshian, H., & Vo, L. (2015). A modified olanzapine regimen for the prevention of chemotherapy-induced nausea and vomiting. The Journal of Community and Supportive Oncology, 13, 388–391.
To compare regimens using fosaprepitant and olanzapine for chemotherapy-induced nausea and vomiting (CINV) prevention
Patients on regimens for the prevention of CINV who were receiving highly emetogenic chemotherapy (HEC) received either a medication regimen of fosaprepitant, ondansetron, and dexamethasone, or a regimen of olanzapine, ondansetron, and dexamethasone. Those on the olanzapine regimen only received dexamethasone on day 1. Both groups had additional rescue medication as needed. All patients were assessed within 24–72 hours for CINV via follow-up phone calls, with results documented in the electronic medical record.
Complete response defined as no emesis after cycle 1. A difference of 15% complete response (CR) rate was used as the limit for noninferiority testing.
The difference in the CR rate between groups was 8.9% in the acute phase, 12.9% in the delayed phase, and 8.6% overall. Statistical analysis showed that results in the olanzapine group were not inferior based on the difference level specified. Comparison of wholesale acquisition costs showed that the olanzapine regimen was less than 4% of the cost of the regimen using fosaprepitant ($8.58 versus $265.59).
The olanzapine regimen tested here was associated with less than a 15% difference in CR rate compared to a regimen containing fosaprepitant.
This study showed that a regimen based on olanzapine was not inferior to one with fosaprepitant among patients receiving HEC if a less than 15% difference in CR rate is clinically acceptable. Individuals on the olanzapine had a higher prevalence of delayed phase CINV, though those in the olanzapine regimen also did not receive dexamethasone after day 1. The fosaprepitant regimen was much more expensive than the olanzapine regimen, so it may be a good alternative for patients with limited coverage or financial resources. Additional studies are needed to identify the most cost-effective regimens for CINV prevention, and this work needs to also provide greater focus on the prevention of nausea.