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.
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;
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;
The initial dose of capecitabine is less than 800mg/m²;
Radiation therapy or surgery should be performed within 4 weeks before the start of treatment;
Skin diseases that may interfere with clinical trial results;
Parallel
True electroacupuncture + True self-administered acupressure
Combination productTrue 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
DrugDoctor-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 electroacupuncture + Sham self-administered acupressure
Combination productSham 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".
HFS incidence rate (Compare the difference between the two groups)
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS. Grade 1: Minimal skin changes or dermatitis (eg, erythema, oedema, or hyperkeratosis) without pain； Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living. The more severe the grade, the more it affects the quality of life of patients.
The incidence of HFS grade 2-3 (Compare the difference between the two groups)
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS. Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; ; limiting self-care activities of daily living. The more severe the grade, the more it affects the quality of life of patients.
The occurrence time of grade 1-3 HFS (Compare the difference between the two groups)
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS. Grade 1: Minimal skin changes or dermatitis (eg, erythema, oedema, or hyperkeratosis) without pain； Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living. The more severe the grade, the more it affects the quality of life of patients.
The occurrence time of grade 2-3 HFS (Compare the difference between the two groups)
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS. Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living. The more severe the grade, the more it affects the quality of life of patients.
The difference in duration (weeks) of grade 1 to 3 HFS between the two groups
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS. Grade 1: Minimal skin changes or dermatitis (eg, erythema, oedema, or hyperkeratosis) without pain； Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living. The more severe the grade, the more it affects the quality of life of patients.
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