RecruitingNot ApplicableNCT06602167

Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome

Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome: a Randomized Controlled Trial


Sponsor

Affiliated Hospital of Qinghai University

Enrollment

220 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study hypothesizes that electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment is effective in preventing Hand-Foot Syndrome (HFS) caused by capecitabine. It aims to explore the effectiveness of this combined approach in preventing HFS in patients with malignant tumors undergoing oral capecitabine treatment. Further exploration of prevention and treatment methods may enhance the quality of life for patients during the treatment process.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether electroacupuncture (acupuncture with mild electrical stimulation) combined with self-administered acupressure (applying pressure to specific points at home) can prevent or reduce hand-foot syndrome — a painful skin condition that can occur as a side effect of the chemotherapy drug capecitabine. **You may be eligible if...** - You are 18 or older - You have gastrointestinal cancer or breast cancer confirmed by pathology - You are about to start treatment with capecitabine for the first time (at a minimum daily dose of 2000 mg/m²) - Your overall health is good (ECOG 0–2) and your blood counts and organ function are adequate - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have previously used capecitabine or other drugs known to cause hand-foot syndrome (such as sorafenib or sunitinib) - You have had surgery or radiation in the past 4 weeks - You have existing skin conditions that might interfere with the study - You have a known drug or alcohol dependency - You are pregnant or breastfeeding - You are afraid of or allergic to acupuncture needles Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTTrue electroacupuncture + True self-administered acupressure

True electroacupuncture: Participants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi" is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2Hz for 30 minutes. True self-administered acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes.

DRUGDoctor-prescribed treatment

Doctor-prescribed treatment: At the beginning of capecitabine, patients will be treated with doctor-recommended medications, including oral celecoxib, topical diclofenac, and other skin protectants.

COMBINATION_PRODUCTSham electroacupuncture + Sham self-administered acupressure

Sham electroacupuncture: The sham electroacupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi" sensation. Sham self-administered acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi".


Locations(1)

Qinghai University Affiliated Hospital

Xining, Qinghai, China

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NCT06602167


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