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

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ClinicalTrials.gov Identifier: NCT05641571
Recruitment Status : Not yet recruiting
First Posted : December 7, 2022
Last Update Posted : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
CIPN - Chemotherapy-Induced Peripheral Neuropathy Behavioral: The home-based extremity exercise program Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Effects of an Exercise Intervention on Taxane-induced Peripheral Neuropathy in Breast Cancer Survivors
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise group
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.
 Behavioral: The home-based extremity exercise program
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.
No Intervention: Observational group
The observational group will need to record the extra exercise performed and the exercise prescription will be distributed after the study.


Outcome Measures
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Primary Outcome Measures :
  1. The incidence and severity of peripheral neuropathy [ Time Frame: Change of peripheral neuropathy from baseline measure at 6 months ]
    Total Neuropathy Score- clinical version, pain 0~100 Visual Analogue Scale, Identification Pain Questionnaire


Secondary Outcome Measures :
  1. The score change in quality of life [ Time Frame: Change of quality of life from baseline measure at 6 months ]
    Functional Assessment for Chronic disease Therapy- Taxane


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641571


Contacts
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Contact: Ya-Jung Wang, PhD 886-919-706218 wangyj@mail.dyu.edu.tw

Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
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Principal Investigator: Chih-Chiang Hung, Doctor Taichung Veterans General Hospital
More Information
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Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT05641571    
Other Study ID Numbers: CF22200A
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Taichung Veterans General Hospital:
Taxane-induced peripheral neuropathy, extremity exercise
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases