Rossi, A., Rosati, G., Colarusso, D., & Manzione, L. (2003). Subcutaneous granulocyte–macrophage colony-stimulating factor in mucositis induced by an adjuvant 5-fluorouracil plus leucovorin regimen. Oncology, 64(4), 353–360.
GMCSF subcutaneously
(4 mcg/kg) from days 6-10 during cycle following the cycle Grade ≥ 2 mucositis was reported.
Also received “standard” anti-mucositis treatment
The study was comprised of 31 patients, age 39-77 years with a median age of 68.
Three stage phase II trial
Colorectal cancer treated with 5FU plus leucovorin and reporting mucositis ≥ Grade 2.
Chen design
WHO Mucositis – 3x/wk:
Grade 0 = none
I = painless ulcers, erythema, or mild soreness
2 = painful erythema, edema, or ulcers
3 = can’t eat solids
4 = TPN or enteral support
77 GM-CSF cycles were administered (median/pt = 3).
Success claimed based on reduction of at least one grade of mucositis.
9 of 20 responders mucositis disappeared – 64.5%
45% with mucositis responded, 12.9% failure, 3.2% stopped treatment
3.2 % (1 patient) with mucositis plus diarrhea responded, 3.2% treatment failure, 3.2% stopped treatment
Toxicity in 7 of 20 patients
Claim results are rationale for well-designed trial
No control group
Small N
No P values stated percentages hard to follow.
Ross, J.R., Goller, K., Hardy, J., Riley, J., Broadley, K., A’hern, R., & Williams, J. (2005). Gabapentin is effective in the treatment of cancer-related neuropathic pain: A prospective, open-label study. Journal of Palliative Medicine, 8, 1118–1126.
To evaluate the effectiveness of gabapentin for cancer-related neuropathic pain
Gabapentin was administered at a dose of 300 mg/day up to 1.8 g/day over 15 days. Final doses were taken in three divided doses. Two parallel groups were recruited with either treatment-related (n = 25) or tumor-related (n = 37) neuropathic pain. Gabapentin was dose-escalated from 300 mg/day to 1.8 g/day. Median dose was 1,200 mg/day. Patient selection was nonrandomized.
Patients were selected from inpatient and outpatient settings in a U.K. tertiary referral center.
Prospective, open-label studies of inpatients and outpatients
Patients completed pain and side-effect scores and were evaluated by a clinician on days 0, 8, and 15. In addition, pain scores were obtained on day 4. Pain was assessed using the modified Brief Pain Inventory (BPI) to measure pain on a 0–10 scale. Patient descriptors of pain and scores of activities of daily living (0–10 scale) were collated together with demographic data. Toxicity scores ranged from “not at all” to “a little,” “quite a bit,” or “very much.”
Baseline and final pain scores were not significantly different between the tumor-related and treatment-related groups. In addition, ANOVA did not show etiology to be a significant predictor of response to gabapentin. Data from both groups were pooled into the primary analysis. A total of 41 patients completed the study, with the median-range dose of gabapentin to be 1,200 mg/day. A total of 28 of 62 patients achieved at least a one-third reduction in their pain score (95% CI); the number needed to treat to obtain this benefit was 2.2. There was a significant reduction in all scores measuring the impact of pain on daily living (p < 0.003). ANOVA suggested that gender and cancer diagnosis, but not etiology of neuropathic pain or type of neuropathic pain, were independent predictors of change in average pain score. There was suggestion that beneficial effect was only in women, not men; men with bowel or lung cancer showed no benefit. This may be a chance subgroup finding. There was significant reduction in worst, average, and current pain scores (p < 0.002), but not in least pain scores. The tumor group described pain as shooting, pins and needles, and the treatment group described pain as hot, burning sensations. There was no significant difference in pain scores on day 8 compared to day 15. No further pain relief was reported from day 8 to day 15—if improvement is not seen in one week, this suggests that an alternative drug should be started. Six patients (10%) discontinued study because of probable drug-related side effects, 14% reported mild/moderate side effects, and 45% were already taking steroids or antidepressants, although doses did not change during the study.
Gabapentin is an effective treatment for cancer-related neuropathic pain from both tumor and treatment.
Side effects included drowsiness, unsteadiness, dizziness, nausea, headache, and others. There was no change in opioids during study—one might question whether there could there be a synergistic effect between gabapentin and opioids. Studies need to be performed to determine if the escalation of a dose greater than 1,800 mg/day is beneficial between men and women and different cancer diagnoses.
Rosenoff, S.H., Gabrail, N.Y., Conklin, R., Hohneker, J.A., Berg, W.J., Ghulam, W., … Anthony, L. (2006). A multicenter, randomized trial of long-acting octreotide for the optimum prevention of chemotherapy-induced diarrhea: Results of the STOP trial. Journal of Supportive Oncology, 4(6), 289–294.
To compare the efficacy of two dose levels of octreotide long-acting release (LAR) in preventing chemotherapy-induced diarrhea (CID) in patients with active or prior CID
A sample of 124 evaluable patients were assigned randomly to either the 30-mg or 40-mg octreotide dose group. The first dose of ocreotide was given intramuscularly 7–14 days prior to day 1 of the patient's next chemotherapy cycle. The second dose coincided with the chemotherapy cycle. Subsequent cycles were given every 28 days up to a total of 6 doses on a schedule independent of the chemotherapy cycles. Prior to initiation of octreotide LAR, patients were given a 100-mcg test dose of octreotide subcutaneously to determine potential intolerance.
This was an open label, randomized, multicenter study with a parallel-group design.
No specific recommendations regarding the superiority of 30 mg or 40 mg octreotide in the management of CID can be made based on this study.
Rosenbaum, M.S., & Velde, J. (2016). The effects of yoga, massage, and reiki on patient well-being at a cancer resource center [Online exclusive]. Clinical Journal of Oncology Nursing, 20, E77–E81.
To evaluate the effects of yoga, massage, and Reiki therapies on stress, pain, anxiety, mood, overall health, and quality of life (QOL)
Data were collected from patients who self-enrolled in yoga, Reiki, and massage services during a six-month period. Patients completed study questionnaires before and after participating in one of these services, within one to three minutes before and after participation.
The time patients had been participating in the service ranges from one month to more than three years. Significant changes in pain levels pre- and postservice provision were reported (p < 0.001). Individuals receiving Reiki had higher preservice pain levels. Center staff encouraged patients with pain to enroll in Reiki. No significant postservice differences in pain across the intervention types were reported. All patients reported lower anxiety scores after receiving the service (p < 0.001) with no differences between groups.
Integrative therapies such as Reiki, massage, and yoga may be helpful for management of symptoms such as pain and anxiety.
This study has numerous limitations and high risk of bias, so no firm conclusions can be drawn about the actual efficacy of the interventions being evaluated.
Rosen, L.S., Abdi, E., Davis, I.D., Gutheil, J., Schnell, F.M., Zalcberg, J., … Clarke, S. (2006). Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy. Journal of Clinical Oncology, 24(433), 5194–5200.
Palifermin was administered at 40 mcg/kg IV for three consecutive days before each of two chemotherapy cycles with fluorouracil (5-FU) or leucovorin (LV).
The study reported on patients with metastatic colorectal cancer receiving 5-FU or LV. The group receiving palifermin had 28 patients, and the group receiving placebo had 36 patients.
This was a phase I and II randomized double-blind, placebo-controlled study.
Roscoe, J.A., Garland, S.N., Heckler, C.E., Perlis, M.L., Peoples, A.R., Shayne, M., . . . Morrow, G.R. (2015). Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment. Journal of Clinical Oncology, 33, 165–171.
To evaluate whether cognitive behavioral therapy for insomnia (CBT-I) in combination with a wakefulness-promoting agent, armodafinil, results in better insomnia outcomes in cancer survivors compared to CBTI-I alone
Randomized, placebo-controlled trial
Analyses controlling for baseline differences showed that both the CBT-I plus armodafinil (p = 0.001) and CBT-I plus placebo (p = 0.010) groups experienced significantly greater reductions in insomnia severity postintervention than the placebo group with effect sizes of 1.31 and 1.02, respectively. Similar improvements were seen for sleep quality. Gains on both measures persisted three months later. CBT-I plus armodafinil was not significantly different from CBT-I plus a placebo (p = 0.421), and armodafinil alone was not significantly different from a placebo alone (p = 0.584).
Considering the prevalence of insomnia in patients with cancer and survivors, the potential for poorer outcomes if insomnia remains untreated, and the efficacy of CBT-I in treating chronic insomnia, it is desirable that providers and patients obtain increased access to evidence-based nonpharmacologic sleep interventions as an integral part of comprehensive cancer care. The findings of this study demonstrated that the addition of armodafinil to CBT-I treatment did not improve results for sleep.
Roscoe, J. A., Matteson, S. E., Mustian, K. M., Padmanaban, D., & Morrow, G. R. (2005). Treatment of radiotherapy-induced fatigue through a nonpharmacological approach. Integrative Cancer Therapies, 4, 8–13.
The intervention involved polarity therapy for a 60- to 70-minute session. A trained therapist used anatomical hand positions (connectors) to examine energy flow, discover trigger points, and restore homeostatic energy flow. Polarity therapy promotes healing, relaxation, and well-being by unblocking and balancing energy flow and reestablishing homeostasis within the human energy field.
Single radiotherapy center
Patients were undergoing the active treatment phase of care.
This was a pilot study with three arms:
A statistically significant improvement was observed in fatigue and health-related quality of life in 10 patients who received polarity therapy versus five who did not. There may have been a dose effect. Eight of 10 patients reported improvement.
Roscoe, J. A., Morrow, G. R., Hickok, J. T., Mustian, K. M., Griggs, J. J., Matteson, S. E., . . . Smith, B. (2005). Effect of paroxetine hydrochloride (Paxil) on fatigue and depression in breast cancer patients receiving chemotherapy. Breast Cancer Research and Treatment, 89, 243–249.
Patients were given oral paroxetine 20 mg daily beginning seven days after the initiation of the first cycle of chemotherapy for newly diagnosed breast cancer and continued until seven days following their fourth cycle of chemotherapy or placebo. Randomization was stratified by type of chemotherapy regimen to achieve a balanced design.
Patients were recruited from a university medical center and two of its affiliated hospitals.
Patients were undergoing the active treatment phase of care.
The study was a multicenter, randomized, double-blind, placebo-controlled trial.
Controlling for baseline fatigue scores, there were no statistically significant differences in fatigue or fatigue interference between the treatment and control groups. There was no relationship between anemia and fatigue at baseline, although changes in anemia over the course of the study were modestly but significantly correlated with one measure of fatigue.
There were costs related to drug acquisition.
Roscoe, J.A., O’Neill, M., Jean-Pierre, P., Heckler, C.E., Kaptchuk, T.J., Bushunow, P., … Smith, B. (2010). An exploratory study on the effects of an expectancy manipulation on chemotherapy-related nausea. Journal of Pain and Symptom Management, 40, 379–390.
To test whether providing information about the expected efficacy of acupressure bands would enhance their effectiveness in reducing nausea
The study was conducted in a single outpatient setting. The location was not stated.
All patients were in active treatment.
This was a double-blind, four-arm, randomized, clinical intervention study.
Patients with enhanced information required less antiemetics and had less nausea than patients with neutral information. Managing expectations may facilitate chemotherapy-induced nausea and vomiting (CINV) management.
This study illustrates the need for nurses to assess and be aware of patient’s nausea expectations during chemotherapy. Patients with high expectations may benefit from information or discussion of the expected benefits of interventions on reducing nausea.
Roscoe, J.A., Matteson, S.E., Morrow, G.R., Hickok, J.T., Bushunow, P., Griggs, J., … Smith, J. (2005). Acustimulation wrist bands are not effective for the control of chemotherapy-induced nausea in women with breast cancer. Journal of Pain and Symptom Management, 29, 376-384.
Patients receiving doxorubicin and cyclophosphamide were randomized to one of three arms.
Participants were told to wear the assigned band and adjust the acustimulation dial to increase or decrease the acustimulation; they could wear the band as frequently as desired over five days.
All participants were treated at outpatient centers at one of four Rochester, NY, area cancer centers.
The study design was a randomized, three-arm trial.
No significant differences were found in any study measures among the three treatment conditions.
The study does not support the use of acustimulation bands as an adjunct to antiemetics in female patients with breast cancer.