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AIM: There is significant recent interest in the role of ginger root (Zingiber officinale) as an adjuvant therapy for chemotherapy-induced nausea. The supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (SPICE) trial aims to assess the efficacy by reduced incidence and severity of chemotherapy-induced nausea and vomiting, and enhanced quality of life, safety and cost effectiveness of a standardised adjuvant ginger root supplement in adults undergoing single-day moderate-to-highly emetogenic chemotherapy.
METHODS: Multisite, double-blind, placebo-controlled randomised trial with two parallel arms and 1:1 allocation. The target sample size is n = 300. The intervention comprises four capsules of ginger root (totalling 60 mg of active gingerols/day), commencing the day of chemotherapy and continuing for five days during chemotherapy cycles 1 to 3. The primary outcome is chemotherapy-induced nausea-related quality of life. Secondary outcomes include nutrition status; anticipatory, acute and delayed nausea and vomiting; fatigue; depression and anxiety; global quality of life; health service use and costs; adverse events; and adherence.
RESULTS: During the five-month recruitment period from October 2017 to April 2018 at site A only, a total of n = 33 participants (n = 18 female) have been enrolled in the SPICE trial. Recruitment is expected to commence at Site B in May 2018.
CONCLUSIONS: The trial is designed to meet research gaps and could provide evidence to recommend specific dosing regimens as an adjuvant for chemotherapy-induced nausea and vomiting prevention and management.
Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (spice) trial: Protocol for a multi-centre double-blind placebo-controlled randomized trialCrichton, M., Marx, W., McCarthy, A., Marshall, S., Molassiotis, A., Ried, K., Bird, R., Lohning, A. E. & Isenring, E., Jun 2018, In : Supportive Care in Cancer. 26, S2, p. S169 eP245.
Research output: Contribution to journal › Meeting Abstract › Research › peer-reviewOpen AccessFile74 Downloads (Pure)