Major Program
Supportive Care and Symptom Management
Research Group
Community Oncology and Prevention Trials
Sponsor
University of South Florida
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT04621721
This two-group, randomized control trial (RCT) will test the effects of a home-based, 16 week
gait/balance training plus resistance (exercise bands) exercise program as compared to an
educational cancer survivorship attention control condition to address persistent
taxane-induced peripheral neuropathy in 312 patients treated for invasive breast cancer with
taxanes at 1 year or more after completion of therapy. Assessments of lower extremity muscle
strength, gait/balance, nerve conduction, neuropathy symptoms, and quality of life (QOL) will
be performed.
The proposed exercise intervention addresses gait/balance impairments and motor (resistance)
components of taxane-induced peripheral neuropathy. The mechanism by which the intervention
achieves the proposed outcomes is though 1) increasing endoneurial blood flow to peripheral
nerves and mitochondria resulting in reduction in neuropathic symptoms (including pain) and
clinical manifestations of peripheral neuropathy, while improving gait/balance in those with
persistent neuropathy; 2) The subsequent increase in nutrient supply allows the mitochondria
to function more efficiently, and may alleviate the neuropathic manifestations of
taxane-induced peripheral neuropathy. 15
This is the first study proposing to test the home-delivery of an exercise intervention
specifically aimed at persistent (long-term) taxane-induced neuropathy. If successful, this
study will provide the only evidence-based intervention for patients suffering from
persistent neuropathy from neurotoxic chemotherapy. Additionally, the home-delivery format
makes this intervention easily translated into clinical practice.
Specific Aims:
In a sample of patients who completed a taxane-containing chemotherapy regimen (> 1 year) for
breast cancer and who have a persistent neuropathy (VAS score of > 3) the specific aims of
this RCT are:
1. To test the efficacy of a 16-week -delivered program of gait/balance training plus
resistance exercise, compared to an educational attention control condition in
increasing muscle strength, improving gait/balance and nerve conduction parameters,
decreasing the severity of taxane-induced peripheral neuropathy symptoms, and increasing
quality of life.
2. To evaluate for differences in muscle strength, gait/balance, sensory (sural) and motor
(peroneal) nerve conduction, peripheral neuropathy symptoms, and quality of life (QOL)
between patients who receive the exercise program, compared to those in an educational
attention control condition controlling for age, BMI, taxane cycles and intervals,
neuropathic pain, neuropathy/pain medications, current resistance exercise participation
and falls/near falls experienced.
gait/balance training plus resistance (exercise bands) exercise program as compared to an
educational cancer survivorship attention control condition to address persistent
taxane-induced peripheral neuropathy in 312 patients treated for invasive breast cancer with
taxanes at 1 year or more after completion of therapy. Assessments of lower extremity muscle
strength, gait/balance, nerve conduction, neuropathy symptoms, and quality of life (QOL) will
be performed.
The proposed exercise intervention addresses gait/balance impairments and motor (resistance)
components of taxane-induced peripheral neuropathy. The mechanism by which the intervention
achieves the proposed outcomes is though 1) increasing endoneurial blood flow to peripheral
nerves and mitochondria resulting in reduction in neuropathic symptoms (including pain) and
clinical manifestations of peripheral neuropathy, while improving gait/balance in those with
persistent neuropathy; 2) The subsequent increase in nutrient supply allows the mitochondria
to function more efficiently, and may alleviate the neuropathic manifestations of
taxane-induced peripheral neuropathy. 15
This is the first study proposing to test the home-delivery of an exercise intervention
specifically aimed at persistent (long-term) taxane-induced neuropathy. If successful, this
study will provide the only evidence-based intervention for patients suffering from
persistent neuropathy from neurotoxic chemotherapy. Additionally, the home-delivery format
makes this intervention easily translated into clinical practice.
Specific Aims:
In a sample of patients who completed a taxane-containing chemotherapy regimen (> 1 year) for
breast cancer and who have a persistent neuropathy (VAS score of > 3) the specific aims of
this RCT are:
1. To test the efficacy of a 16-week -delivered program of gait/balance training plus
resistance exercise, compared to an educational attention control condition in
increasing muscle strength, improving gait/balance and nerve conduction parameters,
decreasing the severity of taxane-induced peripheral neuropathy symptoms, and increasing
quality of life.
2. To evaluate for differences in muscle strength, gait/balance, sensory (sural) and motor
(peroneal) nerve conduction, peripheral neuropathy symptoms, and quality of life (QOL)
between patients who receive the exercise program, compared to those in an educational
attention control condition controlling for age, BMI, taxane cycles and intervals,
neuropathic pain, neuropathy/pain medications, current resistance exercise participation
and falls/near falls experienced.
Intervention
Gait/balance & resistive exercise
Condition
Breast Cancer Female, Chemotherapy-induced Peripheral Neuropathy, Gait Disorders, Neurologic, Balance; Distorted, Muscle Weakness
Investigators
Vu Tuan, MD, Ming Ji, PhD, Teran Wodzinski Patricia, PhD, Haladay Douglas, PhD