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

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

NCT ID: NCT06602167

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

Conditions: Official terms:
Gastrointestinal Neoplasms
Hand-Foot Syndrome
Syndrome

Conditions: Keywords:
electroacupuncture
capecitabine
self-administered acupressure
Hand-foot syndrome
Breast cancer
Gastrointestinal cancers

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Combination Product
Intervention name: True electroacupuncture + True self-administered acupressure
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.
Arm group label: True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group

Intervention type: Drug
Intervention name: Doctor-prescribed treatment
Description: 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.
Arm group label: Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group
Arm group label: True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group

Intervention type: Combination Product
Intervention name: Sham electroacupuncture + Sham self-administered acupressure
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".
Arm group label: Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Qinghai University Affiliated Hospital

Address:
City: Xining
Zip: 810000
Country: China

Contact:

Phone: 13327661976
Email: jiudazhao@126.com

Start date: September 15, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Affiliated Hospital of Qinghai University
Agency class: Other

Source: Affiliated Hospital of Qinghai University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06602167