Effect of electroacupuncture on chemotherapy-induced diarrhea: study protocol for a randomized controlled trial

Chemotherapy-induced diarrhea (CID) is one of the side effects of chemotherapy. Diarrhea not only affects the overall treatment effectiveness but also reduces patients' quality of life. Severe diarrhea can lead to electrolyte imbalance and even be life-threatening. Although acupuncture has been widely used in clinical practice and its effectiveness for managing functional diarrhea has been recognized, there is no sound evidence of its efficacy in managing CID. Therefore, the aim of the proposed randomized controlled trial is to examine the effectiveness and potential risks of using acupuncture for the management of CID and to describe its protocol herein.

This trial will be conducted in a double-blinded manner and comprise two arms that will be investigated across multiple centers in parallel. The study cohort will comprise 168 outpatients who have CID from six Chinese hospitals. The patients will be randomly and equally divided between an intervention group (electroacupuncture) and a control group (micro-electroacupuncture). In the former, acupuncture will be performed with the conventional method to induce the de qi sensation, and in the latter group, acupuncture will be performed with a sham procedure that does not involve the insertion of needles. The acupoints ST25, SP14, SP6, and ST37 will be applied in the two methods. These procedures will be performed three times a week for four consecutive weeks. The number of days on which CID occurred, the incidence of CID, and fecal characteristics are considered as the primary outcomes, and the Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea subscale score and the World Health Organization Quality of Life assessment are considered as secondary outcomes. The patients will be closely observed for complications and fluctuations in vital signs.

If the findings from the trial demonstrate the effectiveness and safety of using acupuncture to treat CID, they could serve as evidence for the clinical application of acupuncture as a complementary treatment for cancer patients during chemotherapy.

Chinese Clinical Trial Registry, ChiCTR2000035715, registered on August 16, 2020.