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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05641571
Other study ID # CF22200A
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date December 31, 2023

Study information

Verified date November 2022
Source Taichung Veterans General Hospital
Contact Ya-Jung Wang, PhD
Phone 886-919-706218
Email wangyj@mail.dyu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 88
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • CIPN - Chemotherapy-Induced Peripheral Neuropathy
  • Peripheral Nervous System Diseases

Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
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Not yet recruiting NCT05959811 - Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients N/A
Recruiting NCT05928429 - Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer N/A
Recruiting NCT05556447 - Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN) N/A
Recruiting NCT05560516 - Qutenza Versus Duloxetine in Chemotherapy-induced Peripheral Neuropathy (CIPN) N/A
Completed NCT03873272 - The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL N/A