Hingmire, S., & Raut, N. (2015). Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens. South Asian Journal of Cancer, 4, 7–10.
To assess the safety and efficacy of aprepitant for chemotherapy-induced nausea and vomiting (CINV) prophylaxis with highly emetogenic cheomtherapy (HEC) or moderately emetogenic chemotherapy (MEC) regimens
Patients received 125 mg aprepitant on day 1 and 80 mg along with palonosetron and dexamethasone
PHASE OF CARE: Active antitumor treatment
Open-label, prospective, observational
For all regimens, CR rates were 96.8%, 93.7%, and 92% for acute, delayed, and overall phases. Nine percent reported side effects; the most common was hiccoughs.
Triple drug antiemetic prophylaxis was effective to manage CINV in most patients.
This study adds to the substantial body of evidence for the efficacy of triple drug antiemetic regimens for the prevention of CINV.
Hines, S., Ramis, M.A., Pike, S., & Chang, A.M. (2014). The effectiveness of psychosocial interventions for cognitive dysfunction in cancer patients who have received chemotherapy: A systematic review. Worldviews on Evidence-Based Nursing, 11, 187–193.
PHASE OF CARE: Late effects and survivorship
The authors indicated that there was insufficient evidence to recommend these interventions and concluded that future research involving CBT interventions for CRCD are unlikely to yield different findings. However, this systematic review and meta-analysis is limited because CBT and neuropsychological interventions and instruments differed, resulting in the inability to pool results.
The authors indicated that additional research using CBT for CRCD is unlikely to indicate efficacy. However, this review was limited by the limited number of studies reviewed, its lack of longitudinal timepoints, and the differences between the CRCD interventions.
Hindley, A., Zain, Z., Wood, L., Whitehead, A., Sanneh, A., Barber, D., & Hornsby, R. (2014). Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiation therapy: Results of a randomized trial. International Journal of Radiation Oncology, Biology, Physics, 90, 748–755.
To demonstrate the potential benefits of topical mometasone furoate (MF) for the prevention of acute radiation reactions with a primary measure/endpoint being the mean modified Radiation Therapy Oncology Group (RTOG) score
Double-blinded, randomized, controlled trial
This study demonstrated that MF cream may be beneficial in reducing the severity of acute radiation skin reactions when compared to diprobase cream applied daily to the irradiated area on the breast during three weeks of RT and two weeks post-RT.
The findings of this study demonstrated that the use of MF cream was more effective than an aqueous cream for the prevention of severe radiodermatitis in women receiving radiation therapy for breast cancer. Mixed results have been seen in various studies using different topical corticosteroids, suggesting that specific steroid selection is important. Overall findings suggest that it may be important to begin topical treatment use prior to radiation rather than using steroids for the treatment of radiodermatitis after it has developed. The optimal schedule for the use of such treatments has not been determined, and it has varied across studies.
Hilpert, F., Stahle, A., Tome, O., Burges, A., Rossner, D., Spatke, K., . . . du Bois, A. (2005). Neuroprotection with amifostine in the first-line treatment of advanced ovarian cancer with carboplatin/paclitaxel-based chemotherapy—A double-blind, placebo-controlled, randomized phase II study from the Arbeitsgemeinschaft Gynäkologische Onkologoie (AGO) Ovarian Cancer Study Group. Supportive Care in Cancer, 13, 797–805.
Women with ovarian cancer scheduled for treatment with carboplatin or paclitaxel-based chemotherapy were randomized to receive either IV premedication with amifostine 740 mg/m2 or placebo for 30 minutes. Data were collected at baseline, after each cycle of chemotherapy, and at three and six months after completion of chemotherapy.
The sample consisted of 71 women with advanced ovarian cancer.
The study was a double-blind, randomized, placebo-controlled study.
Thirty-seven women received amifostine and 34 received the placebo infusion. A significant protective effect of amifostine was found in vibration, two-point discrimination, and deep tendon reflexes. No significant differences were observed for single sensory or motor symptoms; however, amifostine improved sensory neuropathy according to the NCI-CTCAE criteria. Inconsistent results were reported in regard to quality of life.
Higginson, I.J., Bausewein, C., Reilly, C.C., Gao, W., Gysels, M., Dzingina, M., . . . Moxham, J. (2014). An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: A randomised controlled trial. The Lancet. Respiratory Medicine, 2, 979–987.
To assess the effectiveness of a short-term breathlessness support service in facilitating breathlessness mastery in patients with advanced disease
This was a single-blinded, randomized, controlled trial. Research nurses and interviewers were blinded to the treatment allocation. Participants, the trial coordinator, and the trial administrator were aware of the treatment allocation.
An integrative approach to managing breathlessness within a support service improves patient mastery of breathlessness.
Additional research and education on the structure and process of an integrative breathlessness support service for patients with advanced cancer is warranted.
Higashikawa, F., Noda, M., Awaya, T., Nomura, K., Oku, H., & Sugiyama, M. (2010). Improvement of constipation and liver function by plant-derived lactic acid bacteria: A double-blind, randomized trial. Nutrition, 26, 367–374.
To evaluate the effects of yogurts made with different types of lactic acid bacteria (LAB) on the gastrointestinal system.
Participants were recruited via advertisement. Consenting patients were assigned using stratified randomization by defecation frequencies to receive one of three types of yogurt.
Participants consumed 100 g of yogurt daily for a six-week period. Data were collected from clinic visits at two-week intervals.
Hiroshima, Japan
This was a randomized, double-blind study.
Bristol Stool Form Scale
In healthy adults, Lb. plantarum SN13T may improve serum lipid levels and liver function. Actual effects in relieving constipation are unclear.
Effects in relieving constipation are unclear in healthy adults. Additional studies are warranted that include a larger sample and patients with cancer.
Hidderley, M., & Holt, M. (2004). A pilot randomized trial assessing the effects of autogenic training in early stage cancer patients in relation to psychological status and immune system responses. European Journal of Oncology Nursing, 8(1), 61–65.
The intervention was autogenic training (AT), a type of meditation, with mental exercises:
Measurements were taken at baseline and at the end of two monthly periods. Patients were observed for evidence of meditative state. Group 1 (control) received one home visit, and group II (intervention) received one home visit plus two months of AT intervention.
The study reported on a sample of 31 women with early-stage breast cancer.
A randomized controlled trial design was used.
Results showed a p value of 0.0027 between groups for anxiety. T and B cell markers remained similar in both groups. The AT group reported improved HADS anxiety levels (t = 2.00, p = 0.092). There was no statistical difference in HADS scores for patients within the group.
Hesketh, P.J., & Sanz-Altamira, P. (2012). Aprepitant, dexamethasone, and palonosetron in the prevention of doxorubicin/cyclophosphamide-induced nausea and vomiting. Supportive Care in Cancer, 20(3), 653-656.
To evaluate the effectiveness of aprepitant, dexamethasone, and palonosetron in the prevention of nausea and vomiting in patients with breast cancer receiving an initial cycle of doxorubicin and cyclophosphamide (AC)
Patients were asked to keep a diary recording the number and timing of any episodes of vomiting or retching, frequency and timing of use of rescue antiemetics, degree of nausea using a four-point categorical scale, and notation of other medications taken. The patients were called by a study coordinator at 24, 48, 72, 96, and 120 hours after starting chemotherapy to assist the patients in the completion of the diary.
The study was conducted at a single outpatient setting at Lahey Clinic Medical Center in Burlington, MA.
This was a prospective trial.
Patients recorded in diaries the number and timing of any episodes of vomiting or retching, frequency and timing of rescue antiemetic use, and degree of nausea using a four-point categorical scale.
The aprepitant, dexamethasone, and palonosetron appeared to be well tolerated and effective at preventing emesis, with no emesis rates ranging from 92%–97% during the study period. However, 50% of patients still developed some degree of nausea and took antiemetic rescue medications, highlighting the need for further improvement in chemotherapy-induced nausea and vomiting (CINV) control in patients with breast cancer receiving AC.
AC is a common treatment regimen for breast cancer and is highly emetogenic. Further studies exploring ways to better control nausea in this patient population, including the use of nonpharmacologic strategies, are needed.
Hesketh, P.J., Warr, D.G., Street, J.C., & Carides, A.D. (2011). Differential time course of action of 5-HT3 and NK1 receptor antagonists when used with highly and moderately emetogenic chemotherapy (HEC and MEC). Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 19, 1297–1302.
To confirm the differential time course of action noted with a neurokinin 1 (NK1) receptor antagonist (RA) compared to a 5-HT3 RA in the setting of cisplatin-based chemotherapy using the database from three large, phase III trials
Multivariate logistic regression models were used to assess the impact of the first emesis at different time intervals of aprepitant regimens compared to control regimens using a modified intent-to-treat approach. The endpoint was the frequency of first emesis during distinct time intervals from administration of chemotherapy through 120 hours postadministration.
The trials reported on a total of 2,383 patients.
The mean age range of patients was 52–59 years.
The percentage of the sample that was male was not reported but assumed to range from 0%–65%. The percentage of females ranged from 35%–100%.
In study 1 and study 2, primary cancer diagnoses were respiratory, urogenital, digestive, and other. In study 3, primary diagnosis was breast cancer.
The majority (59%–80%) were Caucasian.
A total of 1,527 patients were receiving cisplatin-based HEC and 856 were receiving anthracycline plus cyclophosphamide-based moderately emetogenic chemotherapy (MEC).
All patients were in active treatment.
This was a post-hoc analysis.
Measurement instruments and methods were not specified in this article.
With cisplatin-based, highly emetogenic chemotherapy (HEC), the aprepitant regimen was associated with a lower incidence of first vomiting compared to the standard regimen beginning at the 15–18 hour interval and beyond. This lowered incidence was maintained until the 48–60 hour interval, with the first vomiting incidence reduced by 38%–77%.
With anthracycline-cyclophosphamide-based MEC, the first vomiting incidence was markedly lower, as early as the 3–6 hour interval. This effect was maintained up to the 9–12 hour interval, with the first vomiting incidence reduced by 38%–61%.
Emesis induced by cisplatin is biphasic with the initial peak within 2 hours of cisplatin and the second peak starting 16–18 hours and lasting 48 hours after cisplatin. 5-HT3 medications appear to be most effective in the first 12 hours after cisplatin while NK1-sensitive mechanisms appear to be more effective up to 60 hours after cisplatin.
Anthracycline and cyclophosphamide agents display a monophasic emesis pattern; therefore, better emetic control is noted with NK1-dependent medications much earlier in the treatment cycle.
No discussion was included on how data was collected within each study.
Cisplatin-based regimens require 5-HT3-dependent medications within the first 12 hours and NK1-dependent medications thereafter. Anthracycline- and cyclophosphamide-based regimens appear to be sensitive to both 5-HT3- and NK1-dependent medications.
Hesketh, P.J., Bosnjak, S.M., Nikolic, V., & Rapoport, B. (2011). Incidence of delayed nausea and vomiting in patients with colorectal cancer receiving irinotecan-based chemotherapy. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 19, 2063–2066.
To prospectively determine the frequency of delayed nausea and vomiting with irinotecan-based chemotherapy following day 1 prophylaxis with a 5-HT3 receptor antagonist and dexamethasone
All patients received irinotecan-based chemotherapy. All patients received a standard antiemetic regimen prior to chemotherapy consisting of dexamethasone (8 mg oral or IV) and a 5-HT3 receptor antagonist (8 mg IV or 24 mg oral ondansetron, 100 mg IV or oral dolasetron, and 1 mg IV or 2 mg oral granisetron) given immediately prior to the start of chemotherapy only. No routine antiemetics were prescribed after day one for prophylaxis or delayed emesis. Palonosetron was not permitted in this study. All patients received a prescription for rescue therapy, only to be used during the first 120 hours. Patients were monitored for 120 hours after the initiation of irinotecan by the study coordinator who called at timed intervals to assist patients in completing diaries. During this study, patients only were observed on their first cycle of the irinotecan-based chemotherapy.
The study was conducted at multiple outpatient settings through the St. Elizabeth’s Medical Center in Boston, MA; Holy Family Hospital in Methuen, MA; and the Institute for Radiology and Oncology of Serbia.
This was a prospective, observational study.
The results of the study showed efficacy in reducing or controlling delayed nausea and vomiting during the 24-hour period following administration of a camptothecin analogue, a moderately ematogenic antineoplastic agent, when dexamethasone and a 5-HT3 receptor antagonist was used as prophylaxis for acute chemotherapy-induced nausea and vomiting (CINV).
The use of dexamethasone and a 5-HT3 receptor antagonist prior to administration of a camptothecin analogue is recommended in the literature and has been shown to be beneficial in controlling acute CINV, which contributes in reducing delayed nausea and vomiting.