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

NCT05641571 | Unknown

• 1 other identifier: CF22200A
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Keywords

Taxane-induced peripheral neuropathy, extremity exercise

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of peripheral neuropathy

  Total Neuropathy Score- clinical version, pain 0\~100 Visual Analogue Scale, Identification Pain Questionnaire

  Change of peripheral neuropathy from baseline measure at 6 months

Secondary Outcomes (1)

• The score change in quality of life

  Change of quality of life from baseline measure at 6 months

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Observational group

NO INTERVENTION

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

Interventions

The home-based extremity exercise program BEHAVIORAL

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.

Exercise group

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants who have peripheral neuropathy before chemotherapy or regular exercise are excluded.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Related Publications (1)

• Wang YJ, Hung MC, Wu CJ, Huang CC, Cao HW. Effects of an exercise program on chemotherapy-induced peripheral neuropathy in newly diagnosed breast cancer individuals receiving taxanes: a randomized controlled trial. Support Care Cancer. 2025 Nov 10;33(12):1036. doi: 10.1007/s00520-025-10121-8.

  PMID: 41212417 DERIVED

Study Officials

• Chih-Chiang Hung, Doctor

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Jung Wang, PhD

CONTACT

886-919-706218; wangyj@mail.dyu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: December 7, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share