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

Affiliated Hospital of Qinghai University

Status: Enrolling

Conditions: Breast Cancer; Hand-foot Syndrome; Capecitabine; Self-administered Acupressure; Electroacupuncture; Gastrointestinal Cancers

Treatments: Combination Product: Sham electroacupuncture + Sham self-administered acupressure; Drug: Doctor-prescribed treatment; Combination Product: True electroacupuncture + True self-administered acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06602167

AHQU-2024001

Details and patient eligibility

About

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.

Full description

This study is a parallel-group, blinded (blinding applies to participants, evaluators, investigators, and statisticians) randomized controlled trial designed to explore the preventive effect of electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment on HFS in patients with malignant tumors receiving oral capecitabine and to improve the quality of life for patients during treatment. Participants are randomly assigned to one of two groups: a true electroacupuncture combined with true self-administered acupressure group, or a sham electroacupuncture combined with sham self-administered acupressure group. The true electroacupuncture combined with true self-administered acupressure group receives true electroacupuncture combined with true self-administered acupressure plus doctor-prescribed treatment(oral administration of celecoxib, external application of diclofenac, and other skin protectants). The sham electroacupuncture combined with sham self-administered acupressure group receives sham electroacupuncture combined with sham self-administered acupressure plus the same doctor-prescribed treatment. HFS will be assessed following the initiation of capecitabine treatment, with records kept of the capecitabine dosage, the severity of HFS, onset time, and duration of symptoms. In addition, the HFS-14 questionnaire was used to assess the condition of patients at each cycle.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Sign a written informed consent form;
2. Male or female ≥ 18 years old;
3. 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;
4. The performance status of the Eastern Cancer Collaboration Group is 0-2;
5. Palliative or adjuvant chemotherapy with capecitabine (combination or monotherapy, minimum daily total dose of capecitabine 2000 mg/m^2);
6. Expected lifespan ≥ 3 months;
7. 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;
8. Adequate contraception.

Exclusion criteria

1. Previous use of capecitabine or liposome doxorubicin or any other tyrosine kinase inhibitor that may induce HFS (such as sorafenib, sunitinib, and apatinib) for chemotherapy;
2. The initial dose of capecitabine is less than 800mg/m^2;
3. Radiation therapy or surgery should be performed within 4 weeks before the start of treatment;
4. Skin diseases that may interfere with clinical trial results;
5. Known drug/alcohol abuse;
6. Pregnant women or lactating patients;
7. Participate in another clinical trial and the patient has received the investigational drug within the last 30 days prior to the start of treatment (i.e. follow-up in the previous trial was not exclusive);
8. Known patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles or any component of capecitabine;
9. Receive any acupuncture and moxibustion treatment ,there is lymphedema in the area stimulated by acupuncture;
10. Patients with any chemotherapy- or radiotherapy-related toxicities that have not subsided to grade 2 or lower will be excluded, except for stable sensory neuropathy.
11. Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, except for hair loss, will also be grounds for exclusion.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups

True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group

Experimental group

Description:

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.

Treatment:

Combination Product: True electroacupuncture + True self-administered acupressure

Drug: Doctor-prescribed treatment

Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group

Sham Comparator group

Description:

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.

Treatment:

Drug: Doctor-prescribed treatment

Combination Product: Sham electroacupuncture + Sham self-administered acupressure