Actively Recruiting
Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome: a Randomized Controlled Trial
Led by Affiliated Hospital of Qinghai University · Updated on 2024-12-12
220
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining electroacupuncture with self-administered acupressure and doctor-prescribed treatments can help prevent Hand-Foot Syndrome (HFS) in patients with malignant tumors undergoing oral capecitabine therapy. The study is a randomized, triple-blinded controlled trial designed to explore the preventive effects of this combined approach on HFS and to improve quality of life during cancer treatment. Participants are randomly assigned to receive either true electroacupuncture plus true self-administered acupressure along with doctor-prescribed medications, or sham electroacupuncture plus sham self-administered acupressure with the same medications. True electroacupuncture involves two treatments in the first week of each cycle with electrical stimulation, followed by self-administered acupressure in weeks 2 and 3. The doctor-prescribed treatment includes oral celecoxib, topical diclofenac, and skin protectants. The sham group receives minimally invasive needle insertion without electrical stimulation and non-acupressure point massage without pressure causing the "deqi" sensation, but with the same medication regimen. During the study, participants are monitored for HFS incidence, severity, onset, duration, and pain or sensory changes from the start of capecitabine treatment until 12 weeks after treatment ends. The HFS-14 questionnaire is used regularly to assess patient-reported symptoms and adverse events. Researchers track capecitabine dosage, HFS grades, and quality of life to understand treatment impact. The study duration and follow-up allow thorough evaluation of the combined preventive approach.
CONDITIONS
Brief Title
Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign a written informed consent form
- Male or female aged 18 years or older
- Diagnosed with gastrointestinal or breast cancer by pathology and starting capecitabine treatment for the first time
- Eastern Cancer Collaboration Group performance status of 0-2
- Receiving palliative or adjuvant chemotherapy with capecitabine (minimum daily dose 2000 mg/m²)
- Expected lifespan of at least 3 months
- Laboratory values: platelet count ≥ 100 × 10⁹/L, white blood cell count > 3.0 × 10⁹/L, hemoglobin ≥ 10.0 g/dL, normal liver and kidney function
- Using adequate contraception
You will not qualify if you...
- Previous use of capecitabine, liposome doxorubicin, or tyrosine kinase inhibitors that may cause Hand-Foot Syndrome
- Initial capecitabine dose less than 800 mg/m²
- Radiation therapy or surgery within 4 weeks before starting treatment
- Skin diseases that might interfere with trial results
- Known drug or alcohol abuse
- Pregnant or breastfeeding women
- Participation in another clinical trial with investigational drugs within 30 days prior to this study
- Fear of electroacupuncture or allergy to stainless steel needles or capecitabine components
- Received acupuncture or moxibustion with lymphedema in the area stimulated
- Unresolved chemotherapy- or radiotherapy-related toxicities above grade 2, except stable sensory neuropathy
- Any unresolved skin toxicity from previous treatments except hair loss
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of capecitabine treatment cycles (varies per participant)
Participants receive electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment or sham electroacupuncture combined with sham self-administered acupressure plus the same doctor-prescribed treatment while undergoing capecitabine chemotherapy.
Two electroacupuncture treatments in the first week and self-administered acupressure in weeks 2 and 3 of each treatment cycle
Duration - Up to 12 weeks after end of treatment
Participants are monitored for hand-foot syndrome symptoms and quality of life for up to 12 weeks after the end of capecitabine treatment.
Regular assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000
Actively Recruiting
Research Team
J
Jiuda Zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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