Greig, C.A., Johns, N., Gray, C., MacDonald, A., Stephens, N.A., Skipworth, R.J., . . . Fearon, K.C. (2014). Phase I/II trial of formoterol fumarate combined with megestrol acetate in cachectic patients with advanced malignancy. Supportive Care in Cancer, 22, 1269–1275.
To test the safety, tolerance, and efficacy of an appetite stimulant and an anabolic beta 2 agonist in patients with cancer cachexia
Patients were asked to take formoterol 40 mcg and megestrol 320 mg each morning and 40 mcg formoterol and 160 mg megestrol each evening for eight weeks. Self-reported intake and tablet counts were used to determine patient adherence. Patients were admitted to a clinical research facility on day 1 and discharged after the first dose of study drugs. Patients were contacted by phone after 24 hours for assessment. Additional assessments were done at weeks 2, 4, 6, 8, and 12.
Single arm observational
Patients showed an increase in muscle strength and muscle size. Mean body weight increased by 2.6%. Physical activity increased in three of six patients who responded to treatment. Appetite improved (p = .005). Adverse events were tremor (n = 7), peripheral edema (n = 3), tachycardia (n = 2), and dyspepsia (n = 2).
The combination of megestrol and formoterol may have benefit for patients with cachexia. The sample size of this study was too small to draw conclusions.
The combination of medications tested here may be associated with improved muscle function and appetite in patients with advanced cancer; however, due to the limitations of this study, efficacy and tolerance is not clear. Further well-designed research with these medications is needed to determine efficacy, safety, and tolerance.
Greer, J.A., MacDonald, J.J., Vaughn, J., Viscosi, E., Traeger, L., McDonnell, T., . . . Temel, J.S. (2015). Pilot study of a brief behavioral intervention for dyspnea in patients with advanced lung cancer. Journal of Pain and Symptom Management, 50, 854–860.
To determine the feasibility and usefulness of providing brief behavioral interventions to manage dyspnea in patients with advanced lung cancer
Participants received two 30-minute intervention sessions by the same nurse practioner, the second session provided within four weeks of the first. Two nurse practioners were trained in psychoeducation, behavioral techniques, and relaxation. The first session consisted of the nurse practioner explaining cognitive behavioral therapy and the effects of breathlessness, triggers, physiological factors, and behavioral responses on patients. Patients were taught pursed lip breathing, how to use a battery-operated fan, postural techniques, relaxation exercises, diaphragmatic breathing, and meditation. Participants were provided MP3 players with a recording of the guided breathing exercises to practice at home. The second intervention session consisted of reviewing and reinforcing the above instruction, answering questions, and identifying problems or obstacles.
Participants completed three measurements: the MMRCDS, the Functional Assessment of Cancer Therapy–Lung Trial Outcome Index (FACT-L TOI), and the Hospital Anxiety and Depression Scale (HADS) at baseline and again postassessment (six weeks after enrollment). Also used was the enrollment rate/study completion rate to examine feasibility.
Fifty-seven patients were referred to the study with 32 patients enrolled. Four patients could not complete it and one withdrew, leaving 27 participants completing all study procedures (84%). First intervention sessions were provided in the infusion suite, and half of the second sessions were provided in the infusion suite and half over the phone. Participants reported reduction in dyspnea (MMRCDS) over time and improvement in quality of life (QOL) (FACT–L TOI) and depression (HADS), but no significant differences in anxiety. Results were unchanged for all outcomes when adjusting for primary and secondary analyses for the line of chemotherapy.
This study demonstrates the feasibility and possible benefit of providing brief behavioral interventions to patients with advanced lung cancer to decrease breathlessness, improve QOL, and decrease depression. The study showed that a potential barrier may be the availability of resources and time for staff in cancer centers to provide education and training to patients. With a small sample size and pre/post design, larger randomized controlled studies are needed to determine intervention effectiveness.
Dyspnea, which impairs QOL, is a common symptom in patients with advanced lung cancer. Oncology nurses are in unique position to assess dyspnea and how it relates to patient distress and overall QOL. Nurses trained in strategies and interventions to decrease dyspnea are also in a unique position to provide this education to their patients.
Greer, J.A., Traeger, L., Bemis, H., Solis, J., Hendriksen, E.S., Park, E.R., . . . Safren, S.A. (2012). A pilot randomized controlled trial of brief cognitive-behavioral therapy for anxiety in patients with terminal cancer. Oncologist, 17, 1337–1345.
To examine the use of cognitive-behavioral therapy (CBT) as an intervention to reduce anxiety in patients diagnosed with terminal cancer
CBT was adapted by the development of training modules targeting skills for relaxation, coping, and activity pacing. Eligibility included patients who were 18 years or older with an incurable solid tumor, four weeks post-diagnosis, and found to have anxiety as evidenced by a Hamilton Anxiety Rating Scale (HAM-A) score of 14 or higher. They were screened via telephone and met with a licensed clinical psychologist or postdoctoral psychology fellow for a baseline assessment and self-report questionnaires. If criteria was met, they were randomized to either individualized CBT or a wait-list control group. The intervention group met with a therapist for six to seven (optional) weekly sessions of CBT tailored to patient concerns. A post-treatment or eight-week assessment with a blinded independent evaluator was used, and the nonintervention patients were then able to cross over to receive CBT if desired.
A pilot feasibility and randomized controlled trial design was used.
Forty patients with terminal cancers were randomized to receive CBT (n = 20) or to a wait-list control group (n = 20), with 70% completing the post-treatment assessments. In the treatment group, 80% completed at least five of the six required sessions. Analysis revealed that those receiving CBT had greater improvements in HAM-A scores compared to the control group, with an adjusted mean difference of -5.41 (95% confidence interval: -10.78 to -0.04) and a large effect size for intervention (Cohen’s d = 0.80).
It was found that the majority of patients in the intervention sample were able to complete the requirements of the trial, and beneficial effects were observed in reducing anxiety and improving quality of life over time, but no significant differences in depression between the two groups.
Patients who are newly diagnosed with incurable cancer can be at high risk for anxiety. The early identification of these patients and assisting them in accessing care using CBT can lead to significant improvements in anxiety and quality of care.
Green, E., Zwaal, C., Beals, C., Fitzgerald, B., Harle, I., Jones, J., . . . Wiernikowski, J. (2010). Cancer-related pain management: A report of evidence-based recommendations to guide practice. The Clinical Journal of Pain, 26(6), 449–462.
PURPOSE: To provide evidence-based and consensus recommendations for the management of cancer-related pain to guide practice by assessing existing guidelines to develop standards of care
TYPES OF PATIENTS ADDRESSED: All patients with cancer including pediatric cases, the elderly, the cognitively impaired, and culturally diverse patients. Both non-cancer and cancer-related pain guidelines were considered.
APPLICATIONS: Elder care, end of life care, pediatrics
The reference provides AGREE scores for 11 aspects of pain management across eight published guidelines as well as detailed recommendations for each of these aspects of pain management.
Green, E., Zwaal, C., Beals, C., Fitzgerald, B., Harle, I., Jones, J., . . . Wiernikowski, J. (2010). Cancer-related pain management: A report of evidence-based recommendations to guide practice. The Clinical Journal of Pain, 26, 449–462.
To assess existing guidelines, related and unrelated to cancer, as a means of developing evidence-based, consensual recommendations regarding the management of cancer-related pain in adults and children with cancer
The reference provides AGREE scores for 11 aspects of pain management across the eight published guidelines as well as detailed recommendations for each of the aspects of pain management.
The authors reviewed these guidelines:
The analysis led to the statements and recommendations that follow.
Authors did not identify any conflicts of interest.
This reference, a set of standards of practice, provides extensive and detailed guidance regarding all aspects of pain management. The standards can be a very useful reference through the entire process of pain management for patients with cancer.
Refer to the original document: This summary does not contain the full detail that the guidelines provide. The guidelines discuss opioid dosage determination in detail and recommend nonpharmacologic methods; however, the guidelines do not make specific recommendations about modality.
Greenlee, H., Balneaves, L.G., Carlson, L.E., Cohen, M., Deng, G., Hershman, D., . . . Society for Integrative Oncology. (2014). Clinical practice guidelines on the use of integrative therapies as supportive care in patients treated for breast cancer. Journal of the National Cancer Institute.Monographs, 2014, 346–358.
4,900 references were identified that were published between January 1, 1990 and December 31, 2013. 203 articles were included in the final review although only 174 were referenced. Grades used and reported here were A: recommended, high certainty of benefit, B: recommended, high certainty of moderate to substantial benefit, D: recommends against use, moderate to high certainty of no net benefit, and H: recommends against use, moderate to high certainty that harms outweigh benefits.
Interventions for specific symptoms that had strong recommendations for or against use were:
It appears that only specific types of interventions were included, and there are numerous types of integrative or complementary interventions that were not considered in this review. The findings considered were limited to women with breast cancer. Quality rating of evidence was not discussed individually.
These guidelines provided an evidence-based evaluation of various integrative therapies in women with breast cancer. This set of interventions is not all-inclusive; however, it does provide some guidance to clinicians and others regarding evidence strength in these areas as assessed by this specific study group.
Greenlee, H., Crew, K.D., Capodice, J., Awad, D., Buono, D., Shi, Z., . . . Hershman, D.L. (2016). Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer. Breast Cancer Research and Treatment, 156, 453–464.
To investigate electroacupuncture to prevent or reduce chemotherapy-induced peripheral neuropathy (PN) associated with taxanes
Women with breast cancer scheduled to receive 12 weeks of adjuvant or neoadjuvant paclitaxel were recruited. Patients were randomized to receive either 12 weekly electroacupuncture or sham electroacupuncture treatment. These were done within two days of the weekly chemotherapy administration. A standard acupuncture protocol was used. The sham procedure did not include any true acupuncture points, and no electric current was transmitted. Study assessments were conducted at weeks 6, 12, and 16.
PHASE OF CARE: Active antitumor treatment
Single-blind, sham-controlled, randomized, controlled trial
In the sham group, 45% completed all sessions, and 59% completed the electroacupuncture sessions. The number of sessions attended ranged from 1–12. There were no differences in pain scores at weeks 6 and 12. At week 16, the worst pain in the sham group returned to baseline but increased in the acupuncture group (p = 0.03). There were no differences between groups in biothesiometer or pegboard test results. At week 16, those receiving actual acupuncture reported higher pain on the FACT questionnaires.
Women who received electroacupuncture reported greater increases in pain over time compared to controls. There were no other differences in neuropathy findings between groups.
The findings of this study did not support the use of electroacupuncture to prevent or mitigate symptoms of PN in women receiving paclitaxel chemotherapy.
Green, M.D., Koelbl, H., Baselga, J., Galid, A., Guillem, V., Gascon, P., . . . International Pegfilgrastim 749 Study Group. (2003). A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Annals of Oncology, 14, 29–35.
The purpose of the study was to evaluate the efficacy of a single fixed 6 mg dose of pegfilgrastim compared with daily filgrastim.
Patients were randomly assigned to receive either a single fixed dose injection of 6 mg pegfilgrastim on day 2 of their treatment cycle or daily injections of filgrastim 5 mcg/kg per day, begun about 24 hours after chemotherapy until documented absolute neutrophil count (ANC) of 10 x 109/L or greater. Chemotherapy dose reductions were permitted if patients had grade 3-4 non-hemopoetic toxicities.
Active antitumor treatment
Double-blind randomized phase III
In cycle 1, mean duration of neutropenia was 1.8 days with pegfilgrastim and 1.6 days in the filgrastim group—no significant difference. There were no differences between groups for duration of grade 4 neutropenia during other treatment cycles. The safety profile of pegfilgrastim was similar to that for filgrastim.
A single fixed dose of pegfilgrastim per chemotherapy cycle is as safe and effective as daily filgrastim injections.
No significant study limitations were identified.
This study demonstrated that a single fixed dose of pegfilgrastim was as safe and effective as daily filgrastim in these patients. The ability to provide the same effectiveness with fewer injections can be beneficial to patients.
Grealish, L., Lomasney, A., & Whiteman, B. (2000). Foot massage: A nursing intervention to modify the distressing symptoms of pain and nausea in patients hospitalized with cancer. Cancer Nursing, 23, 237-243.
All participants were in the inpatient setting. No further setting description was provided.
Evidence suggested that massage reduces feelings of nausea. No significant difference was found between the control session pretest mean nausea score and post-test mean nausea score. In contrast, the mean nausea scores for the massage sessions decreased.
Graziano, F., Bisonni, R., Catalano, V., Silva, R., Rovidati, S., Mencarini, E., . . . Lai, V. (2002). Potential role of levocarnitine supplementation for the treatment of chemotherapy-induced fatigue in non-anaemic cancer patients. British Journal of Cancer, 86, 1854–1857.
L-carnitine is essential for glucose and lipid turnover and has a role in maintaining energy metabolism.
A high daily fractionated dose L-carnitine 2-g solution was given twice daily (BID) for seven days. Ifosfamide and cisplatin cause increased renal excretion and alter the usual enzyme pathways, potentially causing asthenia with impaired energy metabolism.
The study included 50 nonanemic adults with stage IV solid tumors receiving combination chemotherapy, including ifosfamide or cisplatin, with palliative treatment intent.
Not described
The study used a prospective, nonrandomized, single-arm trial, open-label, pre-/posttest design.
Functional Assessment of Cancer Therapy-Fatigue (FACT-F), 13 items with ratings from zero to four
All 50 patients were evaluable; 20 patients had fatigue at the first cycle and 30 had fatigue at the second cycle. L-carnitine levels were greater than 30 μm in 100% of the patients, and it was well tolerated. Fatigue was ameliorated in 90% (n = 45) with L-carnitine (p < 0.001). Of the nonresponders, three patients were stable and two got worse.
Cost of supplements and monitoring levels of L-carnitine is unknown.