Previously submitted to: JMIR Research Protocols (no longer under consideration since Nov 14, 2023)
Date Submitted: May 23, 2023
Open Peer Review Period: May 23, 2023 - Jul 18, 2023
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Electroacupuncture for chemotherapy-induced gastrointestinal dysfunction in colorectal cancer: protocol for a 3-arm multi-center RCT
ABSTRACT
Background:
Colorectal cancer (CRC) is the third most common cancer in the world, and chemotherapy is still the mainstay of treatment for CRC. However, gastrointestinal dysfunction is the major side effect of colorectal cancer patients receiving chemotherapy. Numerous studies have reported that acupuncture can improve gastrointestinal dysfunction such as nausea, vomiting, diarrhea, and constipation after chemotherapy. Nevertheless, the efficacy of acupuncture treatment for chemotherapy-induced gastrointestinal dysfunction for colorectal cancer remain unclear. This trial was designed to evaluate the efficacy of electroacupuncture in alleviating gastrointestinal dysfunction after chemotherapy for CRC.
Objective:
This study aims to examine if acupuncture at acupoints, compared with non-acupoint or no acupuncture treatment (patients on the waiting list), can improve GI dysfunction induced by chemotherapy in CRC patients.
Methods:
This is a 3-arm multi-center, randomized controlled study. A total of 231 CRC patients with gastrointestinal dysfunction after chemotherapy will be included in this study. Eligible patients will be randomly assigned to 3 groups: the electroacupuncture group (EA), the sham electroacupuncture group (SEA), and the conventional treatment group (CT). Each eligible participant will go through baseline of 0-day, treatment of 3-day and follow-up of 7-day. Patients in the EA and SEA groups will receive 3 times of acupuncture/sham acupuncture treatment during the treatment phase. The Gastrointestinal symptom rating scale will serve as the primary endpoint. The secondary outcomes will include the Patient Self-Reported Outcomes, the Functional Assessment of Cancer Therapy-Colorectal (V4.0), Zung's Self-Rating Anxiety Scale and Zung's Self-Rating Depression Scale. All assessments will carried out at baseline, after the 3-day intervention or observation period and after completing 7-day follow-up.
Results:
Not applicable
Conclusions:
This study will evaluate the efficacy of electroacupuncture on gastrointestinal dysfunction after chemotherapy in colorectal cancer patients. Clinical Trial: ChiCTR2200062317
Citation
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