Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome

Last updated: December 9, 2024
Sponsor: Affiliated Hospital of Qinghai University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stomach Cancer

Digestive System Neoplasms

Gastric Ulcers

Treatment

True electroacupuncture + True self-administered acupressure

Sham electroacupuncture + Sham self-administered acupressure

Doctor-prescribed treatment

Clinical Study ID

NCT06602167
AHQU-2024001
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sign a written informed consent form;

  2. Male or female ≥ 18 years old;

  3. Patients with gastrointestinal cancer or breast cancer who are diagnosed with cancerby pathology will receive capecitabine treatment for the first time according to thelabel;

  4. The performance status of the Eastern Cancer Collaboration Group is 0-2;

  5. Palliative or adjuvant chemotherapy with capecitabine (combination or monotherapy,minimum daily total dose of capecitabine 2000 mg/m^2);

  6. Expected lifespan ≥ 3 months;

  7. Laboratory requirements: platelet count ≥ 100 × 10^9/L, white blood cellcount>3.0 × 10^9/L, hemoglobin ≥ 10.0 g/dL, normal liver and kidneyfunction;

  8. Adequate contraception.

Exclusion

Exclusion Criteria:

  1. Previous use of capecitabine or liposome doxorubicin or any other tyrosine kinaseinhibitor that may induce HFS (such as sorafenib, sunitinib, and apatinib) forchemotherapy;

  2. The initial dose of capecitabine is less than 800mg/m^2;

  3. Radiation therapy or surgery should be performed within 4 weeks before the start oftreatment;

  4. Skin diseases that may interfere with clinical trial results;

  5. Known drug/alcohol abuse;

  6. Pregnant women or lactating patients;

  7. Participate in another clinical trial and the patient has received theinvestigational drug within the last 30 days prior to the start of treatment (i.e.follow-up in the previous trial was not exclusive);

  8. Known patients who are afraid of electroacupuncture stimulation or allergic tostainless steel needles or any component of capecitabine;

  9. Receive any acupuncture and moxibustion treatment ,there is lymphedema in the areastimulated by acupuncture;

  10. Patients with any chemotherapy- or radiotherapy-related toxicities that have notsubsided to grade 2 or lower will be excluded, except for stable sensory neuropathy.

  11. Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, exceptfor hair loss, will also be grounds for exclusion.

Study Design

Total Participants: 220
Treatment Group(s): 3
Primary Treatment: True electroacupuncture + True self-administered acupressure
Phase:
Study Start date:
October 08, 2024
Estimated Completion Date:
December 31, 2027

Study 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 electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment on HFS in patients with malignant tumors receiving oral capecitabine and to improve the quality of life for patients during treatment. Participants are randomly assigned to one of two groups: a true electroacupuncture combined with true self-administered acupressure group, or a sham electroacupuncture combined with sham self-administered acupressure group. The true electroacupuncture combined with true self-administered acupressure group receives true electroacupuncture combined with true self-administered acupressure plus doctor-prescribed treatment(oral administration of celecoxib, external application of diclofenac, and other skin protectants). The sham electroacupuncture combined with sham self-administered acupressure group receives sham electroacupuncture combined with sham self-administered acupressure plus the same doctor-prescribed treatment. HFS will be assessed following the initiation of capecitabine treatment, with records kept of the capecitabine dosage, the severity of HFS, onset time, and duration of symptoms. In addition, the HFS-14 questionnaire was used to assess the condition of patients at each cycle.

Connect with a study center

  • Qinghai University Affiliated Hospital

    Xining, Qinghai 810000
    China

    Active - Recruiting

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