Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT06602167

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

Led by Affiliated Hospital of Qinghai University · Updated on 2024-12-12

220

Participants Needed

1

Research Sites

168 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent
  • Male or female aged 18 years or older
  • Diagnosed with gastrointestinal or breast cancer by pathology
  • Receiving capecitabine treatment for the first time
  • Eastern Cancer Collaboration Group performance status of 0 to 2
  • Receiving palliative or adjuvant chemotherapy with capecitabine (minimum daily dose 2000 mg/m2)
  • Expected lifespan of at least 3 months
  • Platelet count at least 100 x 10^9/L, white blood cell count above 3.0 x 10^9/L, hemoglobin at least 10.0 g/dL, normal liver and kidney function
  • Using adequate contraception
Not Eligible

You will not qualify if you...

  • Previous use of capecitabine, liposome doxorubicin, or tyrosine kinase inhibitors causing HFS (e.g., sorafenib, sunitinib, apatinib)
  • Initial capecitabine dose less than 800 mg/m2
  • Radiation therapy or surgery within 4 weeks before treatment start
  • Skin diseases that may interfere with trial results
  • Known drug or alcohol abuse
  • Pregnancy or lactation
  • Participation in another clinical trial with investigational drug use within 30 days prior to treatment
  • Fear of electroacupuncture stimulation or allergy to stainless steel needles or capecitabine components
  • Receiving acupuncture or moxibustion with lymphedema in stimulated area
  • Unresolved chemotherapy- or radiotherapy-related toxicities above grade 2 (except stable sensory neuropathy)
  • Any unresolved skin toxicity from previous chemotherapy or radiotherapy except hair loss

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qinghai University Affiliated Hospital

Xining, Qinghai, China, 810000

Actively Recruiting

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Research Team

J

Jiuda Zhao

CONTACT

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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