The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome

NCT05949307 | Unknown

• 1 other identifier: CMUH112-REC1-020
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chemotherapy or target therapy-induced hand-foot syndrome in cancer patients affects the quality of life. At present, there is no better treatment for this side effect of chemotherapy or target therapy. In severe cases, it is necessary to reduce the dose of chemotherapy or target therapy, which may affect the progress and effect of chemotherapy. In recent years, acupuncture has been widely used for many side effects of chemotherapy, such as numbness of hands and feet, gastrointestinal discomfort, and dizziness. There have been many studies have proved to be effective, but quite few studies explored the acupuncture treatment improves the hand-foot syndrome caused by chemotherapy or target therapy in cancer patients. Therefore, the investigators expect to evaluate the efficacy of acupuncture, and applying acupuncture or laser acupuncture to improve hand-foot syndrome caused by chemotherapy or target therapy in cancer patients in the future.

Conditions

Hand-Foot Syndrome

Keywords

acupuncture; laser acupuncture; chemotherapy; target therapy; hand-foot syndrome

Outcome Measures

Primary Outcomes (6)

• The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0

  Evaluate skin symptoms assessed by Common Terminology Criteria for Adverse Events version 5. 0 (total three grade. Grade 1 is minimal skin changes, and grade 3 is severe skin changes)

  Change from Baseline severity of hand-foot syndrome at 3 weeks

• The change of scores of Visual analogue scale (VAS)

  pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain)

  Change from Baseline severity of pain at 3 weeks

• The change of Dermatology Life Quality Index (questionnaire)

  evaluate quality of life assessed by Dermatology Life Quality Index

  Change from Baseline quality of life at 3 weeks

• The change of EORTC QLQ-C30 (questionnaire)

  evaluate quality of life assessed by EORTC QLQ-C30

  Change from Baseline quality of life at 3 weeks

• The change of LF/HF before and after treatment

  testing LF/HF assessed by ANSWatch wrist monitor

  Change from Baseline LF/HF at 3 weeks

• The change of temperature of limbs before and after treatment

  testing temperature assessed by Thermal Imaging Analysis

  Change from Baseline temperature at 3 weeks

Secondary Outcomes (6)

• The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0

  Change from Baseline severity of hand-foot syndrome at 6 weeks

• The change of scores of Visual analogue scale (VAS)

  Change from Baseline severity of pain at 6 weeks

• The change of Dermatology Life Quality Index (questionnaire)

  Change from Baseline quality of life at 6 weeks

• The change of EORTC QLQ-C30 (questionnaire)

  Change from Baseline quality of life at 6 weeks

• The change of LF/HF before and after treatment

  Change from Baseline LF/HF at 6 weeks

Study Arms (3)

Acupuncture group

EXPERIMENTAL

receive acupuncture treatment

Device: acupuncture

Laser acupuncture group

EXPERIMENTAL

receive laser acupuncture treatment

Device: laser acupuncture

Sham laser acupuncture group

SHAM COMPARATOR

receive sham-laser acupuncture treatment

Device: Sham-laser acupuncture

Interventions

acupuncture DEVICE

acupuncture

Acupuncture group

laser acupuncture DEVICE

laser acupuncture

Laser acupuncture group

Sham-laser acupuncture DEVICE

Sham-laser acupuncture

Sham laser acupuncture group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients receiving chemotherapy or targeted therapy
• Age over 20 years old
• Western medicine diagnoses hand-foot syndrome
• Sign the consent form

You may not qualify if:

• Pregnant or planning to become pregnant
• Serious arrhythmia (or cardiac pacemaker installed)
• Epilepsy
• Severe organ failure, such as heart and lung failure, liver and kidney failure
• Psychiatric history, unable to cooperate with acupuncture and assessors
• Those who received traditional Chinese medicine treatment for hand-foot skin reaction

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

Acupuncture Therapy

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief and Attending Physician

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 18, 2023
• Study Start: August 1, 2023
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07