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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Intervention / Treatment: Behavioral: The home-based extremity exercise program

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 Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Jung Wang, PhD; Phone Number: 886-919-706218; Email: wangyj@mail.dyu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score change in quality of life	Functional Assessment for Chronic disease Therapy- Taxane	Change of quality of life from baseline measure at 6 months

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Chih-Chiang Hung, Doctor, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Estimate): December 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Taxane-induced peripheral neuropathy, extremity exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: CF22200A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No