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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hand-Foot Syndrome
• Intervention / Treatment: Device: acupuncture; Device: laser acupuncture; Device: Sham-laser acupuncture

Detailed Description

The investigators design a single-center, sham-controlled, assessor- and subject- blind, randomized clinical trial. 60 subjects will be equally and randomly divided into an acupuncture group, laser acupuncture, and sham-laser acupuncture groups in the 6-week trial. Each subject receives acupuncture, laser acupuncture, or sham-laser acupuncture three times a week for three consecutive weeks depending on their group, with a total of 9 times interventions. Outcome measures include Common adverse events evaluation standard version 5.0 (CTCAE) and Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI) and assessment of cancer patients' quality of life questionnaire (EORTC QLQ-C30). ANSWatch and Thermal Image Camera are also used to assess those subjects. Those outcome measures will be conducted at baseline, the 3rd and the 6th week after the interventions.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Cancer patients receiving chemotherapy or targeted therapy
2. Age over 20 years old
3. Western medicine diagnoses hand-foot syndrome
4. Sign the consent form

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; receive acupuncture treatment	Device: acupuncture; acupuncture
Experimental: Laser acupuncture group; receive laser acupuncture treatment	Device: laser acupuncture; laser acupuncture
Sham Comparator: Sham laser acupuncture group; receive sham-laser acupuncture treatment	Device: Sham-laser acupuncture; Sham-laser acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 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 6 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 6 weeks
The change of EORTC QLQ-C30 (questionnaire)	evaluate quality of life assessed by EORTC QLQ-C30	Change from Baseline quality of life at 6 weeks
The change of LF/HF before and after treatment	testing LF/HF assessed by ANSWatch wrist monitorng LF/HF	Change from Baseline LF/HF at 6 weeks
The change of temperature of limbs before and after treatment	testing temperature assessed by Thermal Imaging Analysis	Change from Baseline temperature at 6 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): March 29, 2024
• Study Completion (Estimated): March 29, 2024

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 9, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: chemotherapy; acupuncture; target therapy; laser acupuncture; hand-foot syndrome
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Skin Diseases; Disease; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Syndrome; Hand-Foot Syndrome
• Other Study ID Numbers: CMUH112-REC1-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No