Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine… (NCT06602167) | Clinical Trial Compass
RecruitingNot Applicable
Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome
China220 participantsStarted 2024-10-08
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
1
HFS incidence rate (Compare the difference between the two groups)
Timeframe: Capecitabine started treatment until 12 weeks after the end of treatment
✕. The initial dose of capecitabine is less than 800mg/m\^2;
✕. Radiation therapy or surgery should be performed within 4 weeks before the start of treatment;
✕. Skin diseases that may interfere with clinical trial results;
✕. Known drug/alcohol abuse;
✕. Pregnant women or lactating patients;
✕. 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);
✕. Known patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles or any component of capecitabine;