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.
