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Effects of an Exercise Intervention on Taxane-induced Peripheral Neuropathy in Breast Cancer Survivors

Primary Purpose

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The home-based extremity exercise program
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for CIPN - Chemotherapy-Induced Peripheral Neuropathy focused on measuring Taxane-induced peripheral neuropathy, extremity exercise

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Participants will be randomly allocated to the experimental or observational group using the two strata: (1) adjuvant or neoadjuvant and (2) paclitaxel, docetaxel, or Taxane plus Platinum. Exclusion Criteria: Participants who have peripheral neuropathy before chemotherapy or regular exercise are excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise group

    Observational group

    Arm Description

    The 3~6 months home-based extremity exercise program will be intervened between newly diagnosed with breast cancer to the completion of chemotherapy. Participants have to perform a total of 50 minutes of exercise including the Ten Skilled Hand exercise fourth a day, 5 minutes each time and Buerger Allen exercise twice a day, 15 minutes each time.

    The observational group will need to record the extra exercise performed and the exercise prescription will be distributed after the study.

    Outcomes

    Primary Outcome Measures

    The incidence and severity of peripheral neuropathy
    Total Neuropathy Score- clinical version, pain 0~100 Visual Analogue Scale, Identification Pain Questionnaire

    Secondary Outcome Measures

    The score change in quality of life
    Functional Assessment for Chronic disease Therapy- Taxane

    Full Information

    First Posted
    October 26, 2022
    Last Updated
    November 30, 2022
    Sponsor
    Taichung Veterans General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05641571
    Brief Title
    Effects of an Exercise Intervention on Taxane-induced Peripheral Neuropathy in Breast Cancer Survivors
    Official Title
    Effects of an Exercise Intervention on Taxane-induced Peripheral Neuropathy in Breast Cancer Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taichung Veterans General Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to examine the effects of an exercise program on the management of TIPN in breast cancer survivors. This experimental study utilizes purposive sampling to recruit 88 adults, newly diagnosed with stage I~III breast cancer women, who are expected to be treated with Taxane chemotherapy in a medical center located in central Taiwan. Participants will be randomly allocated to the experimental or observational group. The main outcomes are peripheral neuropathy and neuropathic pain. The 3~6 months home-based extremity exercise program will be intervened between newly diagnosed with breast cancer to the completion of chemotherapy. Participants have to perform a total of 50 minutes of exercise including the Ten Skilled Hand exercise fourth a day, 5 minutes each time and Buerger Allen exercise twice a day, 15 minutes each time. This study expects that the extremity exercise program will be able to prevent and manage peripheral neuropathy and neuropathic pain via increasing blood circulation. Moreover, the exercise program may also improve functioning and QOL in breast cancer survivors receiving Taxane chemotherapy.
    Detailed Description
    The incidence of breast cancer increases yearly. Taxane is one of the main chemotherapy drugs for breast cancer treatment. Taxane-induced peripheral neuropathy (TIPN) impairs breast cancer survivors' functioning, increases the risk of falls, and impacts quality of life (QOL). As TIPN worsens, there is a need to decrease chemotherapy dosage or terminate treatment. This may reduce the effect of chemotherapy, in addition, to increasing survivor's mortality. Up to date, no evidence-based, effective nonpharmacologic intervention to prevent or manage TIPN. Furthermore, no interventions were recommended by the U.S. Food and Drug Administration or TIPN expert organizations to prevent or treat TIPN. Therefore, the purpose of this study is to examine the effects of an exercise program on the management of TIPN in breast cancer survivors. This experimental study utilizes purposive sampling to recruit 88 adults, newly diagnosed with stage I~III breast cancer women, who are expected to be treated with Taxane chemotherapy in a medical center located in central Taiwan. Participants will be randomly allocated to the experimental or observational group using the two strata: (1) adjuvant or neoadjuvant and (2) paclitaxel, docetaxel, or Taxane plus Platinum. Participants who have peripheral neuropathy before chemotherapy or regular exercise are excluded. The four-measure points are as the followings: (T1) before chemotherapy, (T2) after the completion of the first Taxane, (T3) the completion of half chemotherapy regimen, and (T4) the completion of chemotherapy. The main outcomes are peripheral neuropathy and neuropathic pain. The blood circulation of extremities, functional status, falls and QOL are also measured. SPSS 22 is used to enter and analyze data. Mean, standard deviation, frequency, and percentage are utilized to describe the distribution of the sample and research variables. Chi-squared and generalized estimating equation is used to detect the difference and change over time between the two groups. The 3~6 months home-based extremity exercise program will be intervened between newly diagnosed with breast cancer to the completion of chemotherapy. Participants have to perform a total of 50 minutes of exercise including the Ten Skilled Hand exercise fourth a day, 5 minutes each time and Buerger Allen exercise twice a day, 15 minutes each time. The observational group will need to record the extra exercise performed and the exercise prescription will be distributed after the study. This study expects that the extremity exercise program will be able to prevent and manage peripheral neuropathy and neuropathic pain via increasing blood circulation. Moreover, the exercise program may also improve functioning and QOL in breast cancer survivors receiving Taxane chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    CIPN - Chemotherapy-Induced Peripheral Neuropathy
    Keywords
    Taxane-induced peripheral neuropathy, extremity exercise

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The 3~6 months home-based extremity exercise program will be intervened between newly diagnosed with breast cancer to the completion of chemotherapy. Participants have to perform a total of 50 minutes of exercise including the Ten Skilled Hand exercise fourth a day, 5 minutes each time and Buerger Allen exercise twice a day, 15 minutes each time. The observational group will need to record the extra exercise performed and the exercise prescription will be distributed after the study.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise group
    Arm Type
    Experimental
    Arm Description
    The 3~6 months home-based extremity exercise program will be intervened between newly diagnosed with breast cancer to the completion of chemotherapy. Participants have to perform a total of 50 minutes of exercise including the Ten Skilled Hand exercise fourth a day, 5 minutes each time and Buerger Allen exercise twice a day, 15 minutes each time.
    Arm Title
    Observational group
    Arm Type
    No Intervention
    Arm Description
    The observational group will need to record the extra exercise performed and the exercise prescription will be distributed after the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    The home-based extremity exercise program
    Intervention Description
    Participants have to perform a total of 50 minutes of exercise including the Ten Skilled Hand exercise fourth a day, 5 minutes each time and Buerger Allen exercise twice a day, 15 minutes each time before chemotherapy to the completion of chemotherapy.
    Primary Outcome Measure Information:
    Title
    The incidence and severity of peripheral neuropathy
    Description
    Total Neuropathy Score- clinical version, pain 0~100 Visual Analogue Scale, Identification Pain Questionnaire
    Time Frame
    Change of peripheral neuropathy from baseline measure at 6 months
    Secondary Outcome Measure Information:
    Title
    The score change in quality of life
    Description
    Functional Assessment for Chronic disease Therapy- Taxane
    Time Frame
    Change of quality of life from baseline measure at 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants will be randomly allocated to the experimental or observational group using the two strata: (1) adjuvant or neoadjuvant and (2) paclitaxel, docetaxel, or Taxane plus Platinum. Exclusion Criteria: Participants who have peripheral neuropathy before chemotherapy or regular exercise are excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ya-Jung Wang, PhD
    Phone
    886-919-706218
    Email
    wangyj@mail.dyu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chih-Chiang Hung, Doctor
    Organizational Affiliation
    Taichung Veterans General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of an Exercise Intervention on Taxane-induced Peripheral Neuropathy in Breast Cancer Survivors

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