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

NCT06602167 | Recruiting DMC

• 1 other identifier: AHQU-2024001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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. 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

Capecitabine; Hand-foot Syndrome; Electroacupuncture; Self-administered Acupressure; Breast Cancer; Gastrointestinal Cancers

Keywords

electroacupuncture; capecitabine; self-administered acupressure; Hand-foot syndrome; Breast cancer; Gastrointestinal cancers

Outcome Measures

Primary Outcomes (1)

• HFS incidence rate (Compare the difference between the two groups)

  The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS. Grade 1: Minimal skin changes or dermatitis (eg, erythema, oedema, or hyperkeratosis) without pain； Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living. The more severe the grade, the more it affects the quality of life of patients.

  Capecitabine started treatment until 12 weeks after the end of treatment

Secondary Outcomes (9)

• The incidence of HFS grade 2-3 (Compare the difference between the two groups)

  Capecitabine started treatment until 12 weeks after the end of treatment

• The occurrence time of grade 1-3 HFS (Compare the difference between the two groups)

  Capecitabine started treatment until 12 weeks after the end of treatment

• The occurrence time of grade 2-3 HFS (Compare the difference between the two groups)

  Capecitabine started treatment until 12 weeks after the end of treatment

• The difference in duration (weeks) of grade 1 to 3 HFS between the two groups

  Capecitabine started treatment until 12 weeks after the end of treatment

• The difference in duration (weeks) of grade 2 to 3 HFS between the two groups

  Capecitabine started treatment until 12 weeks after the end of treatment

Study Arms (2)

True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group

EXPERIMENTAL

True electroacupuncture: Participants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi" is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2Hz for 30 minutes. True self-administered acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes. Doctor-prescribed treatment: At the beginning of capecitabine, patients will be treated with doctor-recommended medications, including oral celecoxib, topical diclofenac, and other skin protectants.

Combination Product: True electroacupuncture + True self-administered acupressure; Drug: Doctor-prescribed treatment

Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group

SHAM COMPARATOR

Sham electroacupuncture: The sham electroacupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi" sensation. Sham self-administered acupressure: administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi". Doctor-prescribed treatment: All the drugs used are the same as those in the experimental group.

Drug: Doctor-prescribed treatment; Combination Product: Sham electroacupuncture + Sham self-administered acupressure

Interventions

True electroacupuncture + True self-administered acupressure COMBINATION_PRODUCT

True electroacupuncture: Participants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi" is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2Hz for 30 minutes. True self-administered acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes.

True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group

Doctor-prescribed treatment DRUG

Doctor-prescribed treatment: At the beginning of capecitabine, patients will be treated with doctor-recommended medications, including oral celecoxib, topical diclofenac, and other skin protectants.

Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group; True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group

Sham electroacupuncture + Sham self-administered acupressure COMBINATION_PRODUCT

Sham electroacupuncture: The sham electroacupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi" sensation. Sham self-administered acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi".

Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Hand-Foot Syndrome; Breast Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Jiuda Zhao

CONTACT

869716230893; jiudazhao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)