Murphy, J., Stacey, D., Crook, J., Thompson, B., & Panetta, D. (2000). Testing control of radiation-induced diarrhea with a psyllium bulking agent: A pilot study. Canadian Oncology Nursing Journal, 10(3), 96–100.
To study the effectiveness of psyllium fiber (Metamucil®) taken during pelvic radiation treatment for prostate or gynecological cancer
The experimental group received 1–2 teaspoons psyllium fiber. The control group did not receive any psyllium fiber. Patients in both groups were given a booklet titled “Nutritional Guidelines to Help Control Diarrhea.” Patients kept diaries from day 1 of recruitment through 28 days post-treatment, recording the number of bowel movements per day, consistency of stools, amount of antidiarrhea medication taken, and daily dose of psyllium fiber (for the experimental group).
This was a nonblinded, randomized controlled trial.
Psyllium fiber is a well-tolerated, low-cost, effective intervention for reducing the incidence and severity of radiation-induced diarrhea in patients undergoing pelvic radiation treatment for prostate or gynecologic cancer.
Murakami, M., Hashimoto, H., Yamaguchi, K., Yamaguchi, I., Senba, S., & Siraishi, T. (2013). Effectiveness of palonosetron for preventing delayed chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy in patients with gastrointestinal cancer. Supportive Care in Cancer, 22(4), 905–909.
To determine the effectiveness of palonosetron when compared to granisetron in controlling nausea and vomiting in people with gastrointestinal cancer who were receiving moderately emetogenic chemotherapy
Patients with gastrointestinal cancer receiving their initial dose of induction chemotherapy (moderately emetogenic) either received 3 mg of granisetron or 0.75 mg of palonosetron on day 1 of treatment in addition to standard treatment (6.6 mg IV dexamethasone on day 1 and 8 mg oral dexamethasone on days 2 and 3). Effectiveness of the antiemetics was evaluated on day 5 by comparing occurrence of acute and delayed nausea and vomiting between the two groups.
Prospective observational design, no random assignment of conditions, and no blinding of conditions
The Multinational Association of Supportive Care in Cancer's (MASCC's) Antiemesis Tool (MAT) with additional items about anorexia added. The MAT contains eight items assessing acute and delayed nausea and vomiting and one item assessing anorexia. Participants were asked to complete this measure five days after receiving chemotherapy.
Overall nausea and delayed nausea were significantly lower in the palonosetron group as compared to the granisetron group (p < 0.01). The differences between acute nausea, overall vomiting, delayed vomiting, and acute vomiting were not statistically significant.
Palonosetron effectively controls delayed nausea caused by moderately emetogenic chemotherapy as compared to granisetron in patients with gastrointestinal cancer.
Palonosetron appears to be effective in controlling delayed nausea and would be a useful antiemetic to prescribe for those receiving regimens consisting of moderately emetogenic chemotherapy.
Munoz Langa, J., Gascon, P., de Castro, J., & the Spanish Society of Clinical Oncology. (2012). SEOM clinical guidelines for myeloid growth factors. Clinical and Translational Oncology, 14, 491–498.
The purpose of the study was to facilitate practice based on clinical evidence by establishing practice guidelines on the use of myeloid growth factors. Adults in hematology and oncology were studied.
The resource type was evidence-based guideline. The process of development included a review of the meta-analysis, systematic Cochrane review, and a review of several randomized clinical trials.
The Cochrane database was reviewed. Keywords included neutropenia, febrile neutropenia, myeloid growth factors, G-CSF, clinical practice guidelines, filgrastim, and pegfilgrastim
Active antitumor treatment
This article did not discuss the specific evidence, but outlined benefits of treatment with colony-stimulating factor (CSF) and its use in chemotherapy regimens. Distinguished use as secondary or therapeutic and reviewed the different types of CSFs to be used with which tumor types. The volume of citations was 35.
The use of CSF for primary prophylaxis should be based on the risk of an episode of febrile neutropenia based on disease and chemotherapy regimen. Chemotherapy regimens with risk of febrile neutropenia greater than 20% of primary prophylaxis with CSF is recommended; 10%–20% febrile neutropenia CSF should be considered and less than 10% risk CSF is not recommended. Secondary prophylaxis following an episode of febrile neutropenia or dose-limiting neutropenia, CSF should be considered if not given previously or in cases in which a reduction or delay of the dose is associated with poor prognosis. Therapeutic use when patients present with febrile neutropenia is recommended based on the existing risk factors for poor clinical outcomes or for developing infection-associated complications.
Risk factors are older than age 65 years, sepsis syndrome, severe neutropenia, absolute neutrophil count (ANC) less than 100 mcl or prolonged duration of more than 10 days, pneumonia, invasive fungal infection or other clinically documented infections, hospitalization at time of fever, and prior episode of febrile neutropenia.
Provides professional evidence-based guidelines for use of CSFs for prophylaxis and treatment of febrile neutropenia. Recommendations here are consistent with those of past versions, and are consistent with those of the National Comprehensive Cancer Network and other relevant professional groups.
Mukhopadhyay, S., Kwatra, G., Pamela, A.K., & Badyal, D. (2017). Role of olanzapine in chemotherapy-induced nausea and vomiting on platinum-based chemotherapy patients: A randomized controlled study. Supportive Care in Cancer, 25, 145–154.
To evaluate the efficacy of olanzapine in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving platinum-based chemotherapy and prophylactic palonosetron and dexamethasone
This was a randomized, controlled, assessor-blind study.
Patients recorded the frequency and time of emetic episodes and the frequency and time of rescue antiemetics for the first five days. Patients also used the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) to record the control of nausea and vomiting and intensity of symptoms from days 1–5. Patients also recorded any adverse effects on days 1, 3, and 8–10 and as needed, as well as the duration and severity of the adverse effect. A trained nurse assessed all patients between day 8–10. At this time, the patients' overall quality of life was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30), version 3, questionnaire.
For patients receiving platinum-based chemotherapy, olanzapine is an effective addition for the prevention of CINV. The only side effect listed is more sedation.
Findings not generalizable
Olanazpine is effective for the prevention of CINV in this sample with few adverse effects. It may not be generalizable, but more studies are supporting its use.
Mueller-Lissner, S., Kamm, M.A., Wald, A., Hinkel, U., Koehler, U., Richter, E., & Bubeck, J. (2010). Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of sodium picosulfate in patients with chronic constipation. American Journal of Gastroenterology, 105, 897–903.
To evaluate the effectiveness of sodium picosulfate for constipation.
Patients were randomized to receive either sodium picosulfate or matching placebo drops as treatment. If the study treatment was not effective, 10 mg bisacodyl was used as rescue medication. Patients were allowed to titrate the number of study drug drops to best meet their bowel function needs.
This was a double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The use of laxative with sodium picosulfate in patients with chronic constipation may improve complete spontaneous BMs.
Nurses need to be aware of other agents for the treatment of constipation, as well as the pharmacodynamics in which these agents work.
Mousset, S., Hermann, S., Klein, S. A., Bialleck, H., Duchscherer, M., Bomke, B., . . . Martin, H. (2005). Prophylactic and interventional granulocyte transfusions in patients with haematological malignancies and life-threatening infections during neutropenia. Annals of Hematology, 84, 734–741.
To describe one organization’s experience and findings with the use of prophylactic and interventional granulocyte infusions.
Two different approaches with granulocyte transfusions were used: (1) as an intervention for patients with progressive life-threatening infections and (2) to prevent the recurrence of infections in patients at high risk, including those undergoing allogeneic peripheral stem cell transplant. Patients receiving prophylactic treatment were scheduled for granulocyte transfusion from the beginning of neutropenia in the treatment cycle. As an intervention, transfusions were given to patients with an absolute neutrophil count (ANC) less than 100/mm3 if they had a life-threatening infection despite other prophylactic antimicrobial treatment or severe infections during a previous neturopenic period, with a high risk of recurrence. Timing and frequency of granulocyte transfusions were not described, but it was stated that transfusions were stopped if the ANC was greater than 500/mm3 48 hours after the last transfusion. Outcomes were evaluated 30 days after the first transfusion.
Patients were undergoing the active antitumor treatment phase of care.
This was a descriptive observational study.
European Organization for Research and Treatment of Cancer (EORTC) criteria for the classification of fungal infections
This study described the use of granulocyte transfusions and findings between prophylactic and interventional use related to fungal infections.
* Results reporting provides individual case details but little analysis of results and only analysis of difference between prophylactic use and interventional use in a small subset of patients who developed fungal infections. There was no information regarding antifungal prophylaxis or other aspects of care that can be expected to affect these outcomes. Reporting of percentages varied between the sample percent, cycles, or episodes of transfusion. Many of the cases reported as fungal infection were actually possible rather than actual according to the EORTC criteria used. There was no subgroup analysis between various sample groups with different infection risks.
This study provided minimal information; it described an experience in using granulocyte transfusions.
Moukharskaya, J., Abrams, D.M., Ashikaga, T., Khan, F., Schwartz, J., Wilson, K., . . . Ades, S. (2016). Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim. Supportive Care in Cancer, 24, 3085–3093.
To investigate the effects of prophylactic antihistamine on colony-stimulating factor(CSF)–related bone pain
The study included observation and treatment phases. Patients receiving pegfilgrastim completed pain surveys during the observation phase. Patients who developed significant pain were randomized to loratadine 10 mg daily or a matched placebo for seven days beginning on the day of pegfilgrastim administration. Rescue analgesics were recorded. Bone pain was assessed at baseline and on day 8 during both study phases.
Significant bone pain occurred in 30.5% of patients and worst pain score increased on average from 1.6 to 3.6 during the eight days following pegfilgrastim (p < 0.001). Patients receiving taxanes were more likely to develop significant pain (50.8% versus 23%, p < 0.001). There were no significant differences in baseline pain scores or change in pain scores between study groups. There were no significant differences between groups in analgesic use. Among patients receiving taxane, 90% benefited from loratadine, compared to 27.3% in the placebo arm (p = 0.0008). Both study groups receiving taxanes showed increased worst pains scores from baseline.
In the total sample, antihistamine prophylaxis did not demonstrate a benefit for prevention of CSF-induced bone pain. Findings suggest that there may be some effects for patients receiving taxanes; however, the sample size is too small to draw firm conclusions.
This study did not show any benefit of antihistamine for prevention of CSF-related bone pain. Findings suggest that further research in this area is needed, and specific examination of any benefits in patients receiving taxanes should be further investigated.
Motallebnejad, M., Akram, S., Moghadamnia, A., Moulana, Z., & Omidi, S. (2008). The effect of topical application of pure honey on radiation-induced mucositis: A randomized clinical trial. Journal of Contemporary Dental Practice, 9(3), 40–47.
Patients received 20 mL pure, natural honey 14 minutes before radiotherapy, then 20 mL 15 minutes and six hours after radiotherapy. Honey was rinsed and gradually swallowed to coat the oral and pharyngeal mucosa.
OMAS scores were significantly lower for the honey group than the control group for all weeks (p = 0.000). Significant differences were noted during week six of therapy. Mean weight loss was significantly higher in the control group (p = 0.000).
Moss, E. L., Simpson, J. S., Pelletier, G., & Forsyth, P. (2006). An open-label study of the effects of bupropion SR on fatigue, depression and quality of life of mixed-site cancer patients and their partners. Psycho-Oncology, 15, 259–267.
Bupropion sustained release (SR) was administered for four weeks at the maximum tolerated dose. Dosing was initiated at 100 mg in the morning and adjusted in increments of 50 mg, based on tolerability and effects, to a maximum of 300 mg daily. It was given in divided doses of either 100 or 150 mg. The dose was not increased if the maximum tolerable dose had been identified. The dose was 300 mg per day until the Brief Fatigue Inventory (BFI) score had dropped to less than 50% of the initial value. Following dose escalation, a four-week, fixed-dose phase occurred at the maximum tolerated dose, during which efficacy and safety measures were assessed every two weeks. The average dose for bupropion SR was 214 mg per day (standard deviation = 80 mg).
The study used a prospective, variable dose, open-label trial design.
Moslehi, A., Taghizadeh-Ghehi, M., Gholami, K., Hadjibabaie, M., Jahangard-Rafsanjani, Z., Sarayani, A., ... Ghavamzadeh, A. (2014). N-acetyl cysteine for prevention of oral mucositis in hematopoietic SCT: A double-blind, randomized, placebo-controlled trial. Bone Marrow Transplantation, 49(6), 818–823.
To determine the effect of n-acetyl cysteine (NAC) on the incidence and severity of oral mucositis glutathione peroxidase-1 activity
Patients were randomized to groups by a researcher not involved in the assessment of study outcomes. This same researcher also provided either the study drug or the placebo to the administrating nurse. Nurses were not blinded to the study groups, but treating physicians and those involved in the assessment of study data were blinded to the groups.
The study group was given NAC at 100 mg/kg of body weight diffused in 500 ml dextrose solution 5%. The drug was infused over a three-hour period beginning on the same day as high-dose chemotherapy (HDC) and continuing until 15 days post-transplantation. A placebo infusion was given to control subjects. Patients were assessed daily beginning the first day of HDC and continuing for 21 days post-transplantation or until mucositis resolved.
PHASE OF CARE: Active antitumor treatment
Double-blind, randomized, placebo-controlled study
The overall incidence of all grades of oral mucositis (OM) did not differ between groups. The incidence of severe OM (grades 3 and 4) was significantly lower in the intervention group (23.7%) compared to the control group (45.2%) (p = 0.04). No patients in the intervention group developed grade 4 mucositis while seven patients in the control group developed grade 4 mucositis. Patients who received NAC had a significantly shorter duration of mucositis (6.24 days) compared to controls (8.12 days) (p = 0.02). There was no difference in the time to onset of mucositis between groups. The use of parenteral opioid analgesics was not significantly different between study groups.
In this study, patients in the intervention group experienced less severe oral mucositis. No patients who received NAC developed grade 4 mucositis. Additionally, patients receiving NAC had a shorter duration of oral mucositis compared to controls. There was, however, no difference in the overall incidence of all grades of mucositis (grades 0–4) and no difference in the time to onset of mucositis between groups.
NAC was shown to decrease the severity and duration of OM and was well tolerated by the patients in this study. Patients undergoing transplant can benefit from these findings as the toxicities of increased pain, potential for infection, impaired nutritional intake, and prolonged hospitalization can be decreased. Nurses should carefully asses patients for the presence of mucositis during treatment with HDC and continue assessments until mucositis has resolved.