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

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ClinicalTrials.gov Identifier: NCT05949307
Recruitment Status : Not yet recruiting
First Posted : July 18, 2023
Last Update Posted : July 18, 2023
Sponsor:
Information provided by (Responsible Party):
Yu-Chen Lee, China Medical University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hand-Foot Syndrome Device: acupuncture Device: laser acupuncture Device: Sham-laser acupuncture Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : March 29, 2024
Estimated Study Completion Date : March 29, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0 [ Time Frame: Change from Baseline severity of hand-foot syndrome at 3 weeks ]
    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)

  2. The change of scores of Visual analogue scale (VAS) [ Time Frame: Change from Baseline severity of pain at 3 weeks ]
    pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain)

  3. The change of Dermatology Life Quality Index (questionnaire) [ Time Frame: Change from Baseline quality of life at 3 weeks ]
    evaluate quality of life assessed by Dermatology Life Quality Index

  4. The change of EORTC QLQ-C30 (questionnaire) [ Time Frame: Change from Baseline quality of life at 3 weeks ]
    evaluate quality of life assessed by EORTC QLQ-C30

  5. The change of LF/HF before and after treatment [ Time Frame: Change from Baseline LF/HF at 3 weeks ]
    testing LF/HF assessed by ANSWatch wrist monitor

  6. The change of temperature of limbs before and after treatment [ Time Frame: Change from Baseline temperature at 3 weeks ]
    testing temperature assessed by Thermal Imaging Analysis


Secondary Outcome Measures :
  1. The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0 [ Time Frame: Change from Baseline severity of hand-foot syndrome at 6 weeks ]
    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)

  2. The change of scores of Visual analogue scale (VAS) [ Time Frame: Change from Baseline severity of pain at 6 weeks ]
    pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain)

  3. The change of Dermatology Life Quality Index (questionnaire) [ Time Frame: Change from Baseline quality of life at 6 weeks ]
    evaluate quality of life assessed by Dermatology Life Quality Index

  4. The change of EORTC QLQ-C30 (questionnaire) [ Time Frame: Change from Baseline quality of life at 6 weeks ]
    evaluate quality of life assessed by EORTC QLQ-C30

  5. The change of LF/HF before and after treatment [ Time Frame: Change from Baseline LF/HF at 6 weeks ]
    testing LF/HF assessed by ANSWatch wrist monitorng LF/HF

  6. The change of temperature of limbs before and after treatment [ Time Frame: Change from Baseline temperature at 6 weeks ]
    testing temperature assessed by Thermal Imaging Analysis


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yu-Chen Lee, Chief and Attending Physician, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT05949307    
Other Study ID Numbers: CMUH112-REC1-020
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: July 18, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yu-Chen Lee, China Medical University Hospital:
acupuncture
laser acupuncture
chemotherapy
target therapy
hand-foot syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Hand-Foot Syndrome
Syndrome
Disease
Pathologic Processes
Drug Eruptions
 Dermatitis
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders