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

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• Sign a written informed consent form;

• Male or female ≥ 18 years old;

• Patients with gastrointestinal cancer or breast cancer who are diagnosed with cancer by pathology will receive capecitabine treatment for the first time according to the label;

• The performance status of the Eastern Cancer Collaboration Group is 0-2;

• Palliative or adjuvant chemotherapy with capecitabine (combination or monotherapy, minimum daily total dose of capecitabine 2000 mg/m\^2);

• Expected lifespan ≥ 3 months;

• Laboratory requirements: platelet count ≥ 100 × 10\^9/L, white blood cell count\>3.0 × 10\^9/L, hemoglobin ≥ 10.0 g/dL, normal liver and kidney function;

• Adequate contraception.

Locations
Other Locations
China
Qinghai University Affiliated Hospital
RECRUITING
Xining
Contact Information
Primary
Jiuda Zhao
jiudazhao@126.com
869716230893
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 220
Treatments
Experimental: True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group
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. 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.
Sham_comparator: Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group
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. Doctor-prescribed treatment: All the drugs used are the same as those in the experimental group.
Related Therapeutic Areas
Sponsors
Leads: Affiliated Hospital of Qinghai University

This content was sourced from clinicaltrials.gov

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