Currently submitted to: JMIR Research Protocols
Date Submitted: Nov 28, 2019
Open Peer Review Period: Nov 27, 2019 - Jan 22, 2020
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Study protocol assessing the benefits of foot reflexology in digestive or lung cancer patients on platinum-based chemotherapy – Randomized controlled trial REFYO-R
Side effects of chemotherapy are feared by patients, specifically chemotherapy-induced nausea and vomiting. To relieve them, it is recommended to prescribe antiemetic drugs. However, some patients report that they are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in alternative and complementary medicines and express the desire that non-pharmacological treatments be used in hospitals. Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients. Some chemotherapy for lung and digestive cancer patients is moderately or highly emitting.
The primary objective of the present study is to assess the benefits of foot reflexology as a complement to conventional treatments on severity and frequency of chemotherapy-induced nausea and vomiting in digestive or lung cancer patients. The secondary objectives are quality of life, anxiety, and self-esteem.
This study is an open label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogic scale, and the frequency of this between the two groups.
The results of this trial are expected in the first quarter of 2020. Patient enrolment is currently ongoing.
The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend this use. The present study will provide evidence on the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs. Clinical Trial: The present study registered with clinicaltrials.gov: NCT03508180 (28/06/2018)
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