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

Primary Purpose

Hand-Foot Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
laser acupuncture
Sham-laser acupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand-Foot Syndrome focused on measuring acupuncture, laser acupuncture, chemotherapy, target therapy, hand-foot syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cancer patients receiving chemotherapy or targeted therapy Age over 20 years old Western medicine diagnoses hand-foot syndrome Sign the consent form Exclusion Criteria: Pregnant or planning to become pregnant Serious arrhythmia (or cardiac pacemaker installed) Epilepsy Severe organ failure, such as heart and lung failure, liver and kidney failure Psychiatric history, unable to cooperate with acupuncture and assessors Those who received traditional Chinese medicine treatment for hand-foot skin reaction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Acupuncture group

    Laser acupuncture group

    Sham laser acupuncture group

    Arm Description

    receive acupuncture treatment

    receive laser acupuncture treatment

    receive sham-laser acupuncture treatment

    Outcomes

    Primary Outcome Measures

    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)
    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)
    The change of Dermatology Life Quality Index (questionnaire)
    evaluate quality of life assessed by Dermatology Life Quality Index
    The change of EORTC QLQ-C30 (questionnaire)
    evaluate quality of life assessed by EORTC QLQ-C30
    The change of LF/HF before and after treatment
    testing LF/HF assessed by ANSWatch wrist monitor
    The change of temperature of limbs before and after treatment
    testing temperature assessed by Thermal Imaging Analysis

    Secondary Outcome Measures

    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)
    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)
    The change of Dermatology Life Quality Index (questionnaire)
    evaluate quality of life assessed by Dermatology Life Quality Index
    The change of EORTC QLQ-C30 (questionnaire)
    evaluate quality of life assessed by EORTC QLQ-C30
    The change of LF/HF before and after treatment
    testing LF/HF assessed by ANSWatch wrist monitorng LF/HF
    The change of temperature of limbs before and after treatment
    testing temperature assessed by Thermal Imaging Analysis

    Full Information

    First Posted
    June 28, 2023
    Last Updated
    July 9, 2023
    Sponsor
    China Medical University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05949307
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    March 29, 2024 (Anticipated)
    Study Completion Date
    March 29, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Medical University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hand-Foot Syndrome
    Keywords
    acupuncture, laser acupuncture, chemotherapy, target therapy, hand-foot syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture group
    Arm Type
    Experimental
    Arm Description
    receive acupuncture treatment
    Arm Title
    Laser acupuncture group
    Arm Type
    Experimental
    Arm Description
    receive laser acupuncture treatment
    Arm Title
    Sham laser acupuncture group
    Arm Type
    Sham Comparator
    Arm Description
    receive sham-laser acupuncture treatment
    Intervention Type
    Device
    Intervention Name(s)
    acupuncture
    Intervention Description
    acupuncture
    Intervention Type
    Device
    Intervention Name(s)
    laser acupuncture
    Intervention Description
    laser acupuncture
    Intervention Type
    Device
    Intervention Name(s)
    Sham-laser acupuncture
    Intervention Description
    Sham-laser acupuncture
    Primary Outcome Measure Information:
    Title
    The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0
    Description
    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)
    Time Frame
    Change from Baseline severity of hand-foot syndrome at 3 weeks
    Title
    The change of scores of Visual analogue scale (VAS)
    Description
    pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain)
    Time Frame
    Change from Baseline severity of pain at 3 weeks
    Title
    The change of Dermatology Life Quality Index (questionnaire)
    Description
    evaluate quality of life assessed by Dermatology Life Quality Index
    Time Frame
    Change from Baseline quality of life at 3 weeks
    Title
    The change of EORTC QLQ-C30 (questionnaire)
    Description
    evaluate quality of life assessed by EORTC QLQ-C30
    Time Frame
    Change from Baseline quality of life at 3 weeks
    Title
    The change of LF/HF before and after treatment
    Description
    testing LF/HF assessed by ANSWatch wrist monitor
    Time Frame
    Change from Baseline LF/HF at 3 weeks
    Title
    The change of temperature of limbs before and after treatment
    Description
    testing temperature assessed by Thermal Imaging Analysis
    Time Frame
    Change from Baseline temperature at 3 weeks
    Secondary Outcome Measure Information:
    Title
    The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0
    Description
    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)
    Time Frame
    Change from Baseline severity of hand-foot syndrome at 6 weeks
    Title
    The change of scores of Visual analogue scale (VAS)
    Description
    pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain)
    Time Frame
    Change from Baseline severity of pain at 6 weeks
    Title
    The change of Dermatology Life Quality Index (questionnaire)
    Description
    evaluate quality of life assessed by Dermatology Life Quality Index
    Time Frame
    Change from Baseline quality of life at 6 weeks
    Title
    The change of EORTC QLQ-C30 (questionnaire)
    Description
    evaluate quality of life assessed by EORTC QLQ-C30
    Time Frame
    Change from Baseline quality of life at 6 weeks
    Title
    The change of LF/HF before and after treatment
    Description
    testing LF/HF assessed by ANSWatch wrist monitorng LF/HF
    Time Frame
    Change from Baseline LF/HF at 6 weeks
    Title
    The change of temperature of limbs before and after treatment
    Description
    testing temperature assessed by Thermal Imaging Analysis
    Time Frame
    Change from Baseline temperature at 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cancer patients receiving chemotherapy or targeted therapy Age over 20 years old Western medicine diagnoses hand-foot syndrome Sign the consent form Exclusion Criteria: Pregnant or planning to become pregnant Serious arrhythmia (or cardiac pacemaker installed) Epilepsy Severe organ failure, such as heart and lung failure, liver and kidney failure Psychiatric history, unable to cooperate with acupuncture and assessors Those who received traditional Chinese medicine treatment for hand-foot skin reaction

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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