Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome
Recruiting · NCT06602167 · Interventional (participants receive a specific treatment) · Lead sponsor: Affiliated Hospital of Qinghai University
View the official record on ClinicalTrials.gov →Interventions studied
Doctor-prescribed treatmentSham electroacupuncture + Sham self-administered acupressureTrue electroacupuncture + True self-administered acupressure
What this trial is 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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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;
- 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;
- Receive any acupuncture and moxibustion treatment ,there is lymphedema in the area stimulated by acupuncture;
- 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.
- Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, except for hair loss, will also be grounds for exclusion.
Where it is running
1 location listed.
- Qinghai University Affiliated Hospital - Xining, Qinghai, China