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

Hand-Foot Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05949307
• Other study ID #: CMUH112-REC1-020
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 29, 2024

Study information

• Verified date: July 2023
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand-Foot Syndrome
• Syndrome

Intervention

Device:
• acupuncture
acupuncture
• laser acupuncture
laser acupuncture
• Sham-laser acupuncture
Sham-laser acupuncture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The change of temperature of limbs before and after treatment	testing temperature assessed by Thermal Imaging Analysis	Change from Baseline temperature at 6 weeks