Martin-Broto, J., Cleeland, C.S., Glare, P.A., Engellau, J., Skubitz, K.M., Blum, R.H., . . . Atchison, C. (2014). Effects of denosumab on pain and analgesic use in giant cell tumor of bone: Interim results from a phase II study. Acta Oncologica, 53, 1173–1179.
To describe the effect of denosumab on pain and analgesic use in patients with giant cell tumor of bone (GCTB)
Patients were split into two groups, cohort 1, which contained patients with unresectable disease or multiple lesions, and cohort 2, which contained patients with resectable disease but for whom surgery was associated with high morbidity. Patients received denosumab every four weeks with additional doses on days 8 and 15. Pain was assessed with the Brief Pain Inventory Short Form at baseline and each visit for the first six months and every three months thereafter.
Denosumab is a reasonable treatment choice for pain relief in patients with GCTB with unresectable disease, disease with multiple lesions, or for patients in whom resection would be associated with high morbidity. This treatment would reduce radiotherapy-related risks and provide a medical option for treating patients in who surgical intervention (the treatment of choice) is not a option or is presented as a high-risk option.
Denosumab is an easy drug to administer that has few side effects. Education on the drug and its administration would be required to effectively treat patients limited to this option. Nurses could help advocate for patients with unresectable disease or disease associated with high morbidity with surgery. This could be an alternative to radiation if patients are unable to receive radiation or are concerned about the low but present risk of secondary tumors from radiation treatment.
Marti-Carvajal, A.J., Anand, V., & Sola, I. (2015). Treatment for disseminated intravascular coagulation in patients with acute and chronic leukemia. Cochrane Database of Systematic Reviews, 6, CD008562.
STUDY PURPOSE: To assess the benefits and harms of pharmacologic interventions for treating patients with leukemia experiencing disseminated intravascular coagulation (DIC) to update a prior systematic review
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Not specified or not applicable
Interventions included human activated protein C versus heparin, recombinant human soluble thrombomodulin versus heparin, tanexamic acid versus placebo, and dermatan sulfate versus heparin. Only one study was found for each intervention. No significant differences in bleeding with protein C or dermatan sulfate existed. Recombinant human soluble thrombomodulin was associated with improvement in bleeding symptoms compared to heparin, and lower scoring of hemorrhagic problems with tranexamic acid compared to placebo.
Insufficient high quality evidence exists to fully evaluate these interventions.
Extremely limited evidence regarding the effects of pharmacologic interventions for the management of DIC and associated bleeding exists compared to usual practice using heparin.
Martenson, J.A., Halyard, M.Y., Sloan, J.A., Proulx, G.M., Miller, R.C., Deming, R.L., … Atherton, P.J. (2008). Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: Results of north central cancer treatment group N00CA. Journal of Clinical Oncology, 26, 5248-5253.
To determine the effectiveness of octreotide in reducing treatment-related diarrhea during radiation therapy to the pelvis
Patients were randomized to receive octreotide acetate or placebo. Patients in the treatment group were given 100 µg subcutaneous octreotide acetate on day 1 followed by 20 mg intramuscular octreotide acetate on days 2 and 29. Patients in the control group received placebo by the same routes on the same days.
This was a multisite, collaborative trial of North Central Cancer Treatment Group.
Patients were undergoing the active treatment phase of care.
This was a double-blinded, randomized control trial.
A Bowel Function Questionnaire and a Uniscale Quality of Life (QOL) measure were used.
No statistically significant differences were found between groups. Octreotide did not reduce the severity or incidence of diarrhea during pelvic radiation therapy. Abdominal cramps were worse in patients on the octreotide arm, but the difference was not statistically significant (p = 0.053). Patients receiving octreotide experienced significantly more problems with nocturnal bowel movements (70% versus 45%, p = 0.004), clustering (90% versus 69%, p = 0.004), and blood with bowel movements (57% versus 35%, p = 0.01).
Octreotide did not result in improvement in diarrhea in this population and was associated with more problems. Octreotide did not have an effect on the severity or incidence of diarrhea during pelvic radiation therapy. Some gastroinstestinal (GI) symptoms were worse in patients receiving octreotide compared to placebo.
More clinical research is needed to evaluate the effective prevention of diarrhea during pelvic radiation therapy. Long-acting octreotide (LAO) should not be used outside of a controlled clinical trial setting.
Martenson, J.A., Bollinger, J.W., Sloan, J.A., Novotny, P.J., Urias, R.E., Michalak, J.C., … Levitt, R. (2000). Sucralfate in the prevention of treatment-induced diarrhea in patients receiving pelvic radiation therapy: A North Central Cancer Treatment Group phase III double-blind placebo-controlled trial. Journal of Clinical Oncology, 18(6), 1239–1245.
Patients receiving pelvic external beam radiation therapy were randomly assigned to receive sulcrafate (2 gm four times per day) or placebo.
The study reported on 123 evaluable patients. The treatment group consisted of 62 patients, and the placebo group consisted of 61 patients. The two groups were balanced in terms of factors such as diagnosis, functional status, radiation dosage, and tumor status.
This was a double-blind, randomized controlled trial.
More patients in the treatment group reported fecal incontinence and a need for protective clothing than in the control group (34% versus 16%, p = 0.04). Physician-reported severity of nausea was worse in the treatment group compared to the control group (p = 0.3), although this was not a specific study endpoint.
Sulcrafate did not decrease pelvic radiation therapy-related bowel toxicity by any of the endpoints measured and seems to have aggravated some gastrointestinal symptoms.
Although the patient questionnaire approximated the physician scale, provider assessments of subjective data such as cramping and straining can be unreliable if not obtained directly from the subject.
Marshall-McKenna, R., Morrison, A., Stirling, L., Hutchison, C., Rice, A.M., Hewitt, C., . . . McCartney, E. (2015). A randomised trial of the cool pad pillow topper versus standard care for sleep disturbance and hot flushes in women on endocrine therapy for breast cancer. Supportive Care in Cancer, 24, 1821–1829.
To identify if the cool pad pillow topper (CPPT) decreases sleep disturbance, minimizing the effects of hot flashes. The CPPT is a commercial product promoted to improve quality of sleep disrupted by hot flashes.
The intervention arm of pre- and postmenopausal women received during four weeks standard care consisting in booklets with advice on exercise, physical activity, diet, and the reduction of caffeine and alcohol plus the CPPT. The CPPT is an approved commercial product that removes heat from the body and can be placed on top, outside, or inside the pillowcase.
The instruments for the intervention group were the sleep diaries to evaluate amount of time asleep and changes in sleep disturbance. The number of hot flashes and the severity at night were evaluated with the hot flash score (HFS), both completed daily for four weeks from the point of randomization; they also record number of alcohol units consumed, if any sleeping pills were taken, and the frequency nightwear changed. The Functional Assessment of Cancer Therapy-Breast (FACT-B) and Hospital Anxiety and Depression Scale (HADS) were used at two points—at randomization and at the end of the study.
CPPT is effective as a self-management strategy to reduce sleep disturbance and the severity/frequency of hot flashes. CPPT did not impact quality of life (QOL) or anxiety but reduction in depression was observed. The CPPT appears to be an effective intervention in conjunction with current standard care.
Nurses could recommend the use of the CPPT as no risk or harm is expected and it helps control hot flashes and sleep disturbances associated with endocrine therapies. This is a pilot only; would recommend additional research to note if results are reproducible.
Maroun, J.A., Anthony, L.B., Blais, N., Burkes, R., Dowden, S.D., Dranitsaris, G., . . . Wong, R. (2007). Prevention and management of chemotherapy-induced diarrhea in patients with colorectal cancer: A consensus statement by the Canadian Working Group on Chemotherapy-Induced Diarrhea. Current Oncology, 14, 12–20.
RESOURCE TYPE: Consensus-based guideline
PROCESS OF DEVELOPMENT: Review of selected literature and retrospective review of 63 patients hospitalized for CID
PHASE OF CARE: Active antitumor treatment
No specific broad search and literature review were used. A few study findings are cited. No information was provided regarding the strength of evidence cited.
Algorithm and consensus recommendations are provided for management of CID. Although these guidelines are aimed specifically at colorectal cancer cases, principles are likely to apply to other tumor types. Whether the mechanisms of diarrhea, and, therefore, effective treatments, are the same with various chemotherapy agents is unclear, and research is limited in this area. Prophylactic use of octreotide is suggested for patients who had diarrhea in a previous cycle of treatment in order to attempt to avoid the need for dose reductions or treatment delays.
Markiewicz, M., Dzierzak-Mietla, M., Frankiewicz, A., Zielinska, P., Koclega, A., Kruszelnicka, M., & Kyrcz-Krzemien, S. (2012). Treating oral mucositis with a supersaturated calcium phosphate rinse: comparison with control in patients undergoing allogeneic hematopoietic stem cell transplantation. Supportive Care in Cancer, 20, 2223–2229.
To evaluate the efficacy of supersaturated calcium phosphate rinse (SCPR) with customary care (topical mouth solutions) on measures of severity and consequent interventions and complications
In the treatment group, patients rinsed their mouths four times daily with the SCPR. In the control group, patients received customary topical mouth care with the extract of salvia leaves (twice daily), providone-iodine mouth solution (1% water solution of iodide with polyvinylpyrrolidone) once daily, and fluconazole mouth solution (50 mg fluconazole, 50 mg glycerine, 10 g vitamin A, and 10 g vitamin E with or without 2.5 g benzociaine) twice daily.
The SCPR treatment was administered from the first day of conditioning until patients reached the absolute neutrophil count of greater or equal to 0.2 g/l (a value that was considered an indication of the beginning of neutrophil recovery). Patients self-assessed the level of pain in the mouth and pharynx using a 0–10 visual analog scale (VAS) and measured swallowing problems using a 0–5 VAS.
The same experienced hematologist performed a physical examination of the oral cavity each day throughout the study, ranking cases according to the World Health Organization (WHO) scale for grading oral toxic effects of cancer treatment.
This was a single-site study conducted in an inpatient setting. The study was conducted at the Department of Hematology and Bone Marrow Transplantation at the Medical University of Silesia in Katowice, Poland, in 2009.
This was a prospective randomized, non-blinded, controlled trial with 40 consecutive patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). Half of the patients received treatment with the supersaturated rinse, and the remaining half received customary care with topical mouth solutions. Patients enrolled in this study underwent transplantation in the Medical University of Silesia in Katowice, Poland, in 2009.
The World Health Organization scale (WHO) was used to measure severity of mucositis. Duration was recorded in days. Peak mean pain in mouth was recorded using a 0–10 visual analog scale (VAS). Peak mean swallowing problems were recorded using a 0–5 VAS. Days to absolute neutrophil count of more than 0.5 g/L and days to platelets of more than 20 g/L were recorded.
Interventions and complications were measured in terms of duration of analgesics used (days), duration of total parenteral nutrition (TPN) (days), use of granulocyte colony-stimulating factor (G-CSF), incidence of acute graft-versus-host disease (aGVHD), degree of aGVHD, and incidence of infectious complications.
The findings in this prospective randomized, controlled study confirm findings in a 1992 report of a double-blind, prospective, randomized, controlled trial of 95 patients undergoing HSCT. In that trial, SCPR produced statistically significantly lower measures of pain duration, disease course duration, use of analgesics (morphine), and duration of time to absolute neutrophil recovery than did a fluoride rinse, demonstrating the SCPR regimen has a significant positive effect on oral mucositis associated with chemotherapy and radiotherapy.
These results warrant confirmation in controlled, multicenter, randomized trials. The use of a supersaturated calcium phosphate rinse holds promise for the prevention and early resolution of oral mucositis and appears to have no significant side effects when used four times daily in patients receiving stem cell transplant.
Markes, M., Brockow, T., & Resch, K. L. (2006). Exercise for women receiving adjuvant therapy for breast cancer. Cochrane Database of Systematic Reviews, CD005001.
Databases searched were Cochrane Breast Cancer Specialised Register, MEDLINE, EMBASE, CINAHL, SPORTDiscus, PsycINFO, SIGLE, ProQuest Digital Dissertations, and Conference Papers Index through July 2004.
Treatment evaluated aerobic (walking or cycle ergometer interval training) or resistance exercise, or a combination of both. Exercise programs were of moderate or low intensity, and the interventions included a mixture of supervised and self-directed programs, delivered individually, or in groups.
To be included in this meta-analysis, the exercise intervention had to be of at least six weeks' duration and had to coincide with the adjuvant treatment regimen rather than follow it. Trials in which the exercise intervention was part of a complex intervention (e.g., complete decongestive lymphatic therapy) and trials restricted to local muscular endurance (e.g., training of shoulders, back, or legs only) instead of including all major muscle groups or restricted to stretching exercises were also excluded.
Seven randomized trials and two nonrandomized, controlled trials involving 452 participants met the inclusion criteria. Five trials, involving 317 participants, were used in the meta-analysis specifically for the outcome of fatigue.
Outcomes were physical fitness, psychological distress, symptoms (pain and fatigue), quality of life, body weight or lean body mass, and immune function. Fatigue was evaluated predominantly using the Piper Fatigue Scale. Meta-analysis of the trials in which fatigue was included as an outcome did not identify a statistically significant improvement in fatigue for participants in the exercise intervention groups compared to the control (nonexercising) groups. Statistically significant improvements for cardiorespiratory fitness, anxiety, sleep disturbance, and nausea relief were found.
The methodologic quality of the studies was overall moderate.
Marinangeli, F., Ciccozzi, A., Aloisio, L., Colangeli, A., Paladini, A., Bajocco, C., . . . Varrassi. G. (2007). Improved cancer pain treatment using combined fentanyl-TTS and tramadol. Pain Practice, 4, 307–312.
To facilitate dose escalation of strong opioids by using an opioid-tramadol combination
Of 70 patients, 35 were treated conventionally, with increasing transdermal fentanyl (group F). The other 35 patients received oral tramadol added to their fentanyl before each increment of their transdermal opioid (group T). Patients started fentanyl therapy by taking 25, 50, 75, or 100 mcg/hour, the amount based on equianalgesic dosing. Maximum tramadol dose was 400 mg/day. Rectal tramadol was not used.
The study was conducted in Italy.
Randomized open-label, prospectively evaluated study
Authors used a visual analog scale (VAS) to measure pain.
The combination of a strong opioid and a weak opioid, to treat severe cancer pain, allowed a more gradual increase of analgesic delivery. Therefore, the combination treatment minimized periods of overdosing and underdosing. Combination treatment as specified is a useful alternative, especially when disease and pain progress quickly.
Severe nausea and vomiting occurred in six patients in group T and three in group F, possibly due to a synergistic effect between fentanyl and tramadol. This study was insufficiently powered to show statistically significant differences relating to uncommon or serious side effects.
The greater number of fentanyl dose changes associated with higher fentanyl consumption in group F may support the hypothesis that tolerance is a pharmacologic effect, rather than a result of the rapid progression of disease. Additional study of the synergistic effect of tramadol and fentanyl, with respect to severe nausea and vomiting, is needed.
Marchioro, G., Azzarello, G., Viviani, F., Barbato, F., Pavanetto, M., Rosetti, F., … Vinante, O. (2000). Hypnosis in the treatment of anticipatory nausea and vomiting in patients receiving cancer chemotherapy. Oncology, 59, 100–104.
To evaluate the use of hypnosis in the management of anticipatory nausea and vomiting
Patients received two hours of training in progressive relaxation, followed by a one-hour hypnosis program. No drugs were given in association with the hypnotherapy. After the intervention, patients immediately went to their scheduled chemotherapy.
All patients were from an outpatient setting.
A Visual Analog Scale (VAS) was used to measure complete response (CR) (mild nausea with no vomiting), major response (moderate to severe nausea and one vomiting episode), or no response (none of the above).
In all of the 16 patients in the study, anticipatory nausea and vomiting disappeared. Major responses (moderate to severe nausea, with one vomiting episode) to chemotherapy-induced emesis control occurred in 14 of the 16 patients.
Caution should be used regarding patient selection; some patients should not be hypnotized.