Status:
RECRUITING
Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome
Lead Sponsor:
Affiliated Hospital of Qinghai University
Conditions:
Capecitabine
Hand-foot Syndrome
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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....
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 electr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06602167
Start Date
October 8 2024
End Date
December 31 2027
Last Update
December 12 2024
Active Locations (1)
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1
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000