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

NCT ID: NCT05949307

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-03-29

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.

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.

Conditions

Hand-Foot Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture group

receive acupuncture treatment

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: DEVICE

acupuncture

Laser acupuncture group

receive laser acupuncture treatment

Group Type: EXPERIMENTAL

laser acupuncture

Intervention Type: DEVICE

laser acupuncture

Sham laser acupuncture group

receive sham-laser acupuncture treatment

Group Type: SHAM_COMPARATOR

Sham-laser acupuncture

Intervention Type: DEVICE

Sham-laser acupuncture

Interventions

acupuncture

acupuncture

Intervention Type: DEVICE

laser acupuncture

laser acupuncture

Intervention Type: DEVICE

Sham-laser acupuncture

Sham-laser acupuncture

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu-Chen Lee

Chief and Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CMUH112-REC1-020

Identifier Type: -

Identifier Source: org_study_id