Clinical trial NCT05949307: The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome
Official title: The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hand-Foot Syndrome
Keywords: acupuncture
laser acupuncture
chemotherapy
target therapy
hand-foot syndrome
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0
timeFrame: Change from Baseline severity of hand-foot syndrome at 3 weeks
measure: The change of scores of Visual analogue scale (VAS)
timeFrame: Change from Baseline severity of pain at 3 weeks
measure: The change of Dermatology Life Quality Index (questionnaire)
timeFrame: Change from Baseline quality of life at 3 weeks
measure: The change of EORTC QLQ-C30 (questionnaire)
timeFrame: Change from Baseline quality of life at 3 weeks
measure: The change of LF/HF before and after treatment
timeFrame: Change from Baseline LF/HF at 3 weeks
measure: The change of temperature of limbs before and after treatment
timeFrame: Change from Baseline temperature at 3 weeks
Secondary outcomes:
measure: The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0
timeFrame: Change from Baseline severity of hand-foot syndrome at 6 weeks
measure: The change of scores of Visual analogue scale (VAS)
timeFrame: Change from Baseline severity of pain at 6 weeks
measure: The change of Dermatology Life Quality Index (questionnaire)
timeFrame: Change from Baseline quality of life at 6 weeks
measure: The change of EORTC QLQ-C30 (questionnaire)
timeFrame: Change from Baseline quality of life at 6 weeks
measure: The change of LF/HF before and after treatment
timeFrame: Change from Baseline LF/HF at 6 weeks
measure: The change of temperature of limbs before and after treatment
timeFrame: Change from Baseline temperature at 6 weeks
Other outcomes:
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