Recruiting

Physical Activity

Sponsor:

University of South Florida

Code:

NCT04621721

Conditions

Breast Cancer Female

Chemotherapy-induced Peripheral Neuropathy

Gait Disorders, Neurologic

Balance; Distorted

Muscle Weakness

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Gait/balance & resistive exercise

Study Details

Brief summary:

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.

Conditions

Breast Cancer Female

Chemotherapy-induced Peripheral Neuropathy

Gait Disorders, Neurologic

Balance; Distorted

Muscle Weakness

Study ID

NCT04621721

Start date

Aug 14, 2020

Status verified date

Jul, 2020

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Jul 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female breast cancer survivors (>21) with who completed treatment for invasive breast cancer with taxane-based chemotherapy, and who have a peripheral neuropathy score of > 3 by VAS rating consistent with studies of diabetic peripheral neuropathy.

Exclusion Criteria:

  • any disease (e.g. diabetes, HIV) that results in peripheral neuropathy or muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke,); any disease that would preclude exercise (preexisting cardiopulmonary disease, bone metastasis). Individuals with symptomatic lymphedema or advanced disease at high risk for bone metastases and pathologic fracture will be excluded.

Study Design

Enrollment

312 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Group

The intervention will consist of a 16-week, home-based gait/balance training and progressive resistance exercises for lower extremities using resistance power bands. Participants will be given the home-based gait/balance training and progressive resistance exercise training access via a link or by DVD, and the resistance training band, and wide, firm foam surface. The intervention group will begin with light warm-up and stretching activity then a 10 minute each of gait/balance and 10 minutes of resistive (strength) training components. The program begins with light stretching to address any range of motion limitations that may affect ability to maintain balance and postural stability, and consisted of hamstring quadricep, gastroc, and soleus stretches. During stretching exercises, participants held each stretch for 10-15 seconds, repeating each stretch 2-3 times for each lower extremity. Stretching exercises do not change during the intervention.

active comparator: Attention Control Group

The Attention Control group will receive an educational intervention via a journal in which to record their clinic appointments, and standardized American Cancer Society pamphlets which have been adjusted to fit within the journal binding for easy reference. At each data collection encounter, the intervention research assistant will discuss the information in each pamphlet, allowing time for questions related to the material. The educational materials consist of 1) Emotions and Breast Cancer; 2) Body Image and Sexuality After Breast Cancer; 3) Follow up Care After Breast Cancer Treatment; 4) Nutrition and Cancer. Sessions last approximately 45-60 minutes and occur at the same intervals as the intervention group and will precede data collection. Attention Control group participants will receive telephone calls every other week which will entail a social visit and reminder of data collection/attention intervention appointments to further equalize contact.

Interventions

Gait/balance & resistive exercise

Walking forward and back, walking with head motion, static standing, Standing Partial Tandem, Tandem Standing heel to toe, Standing with head turns Single leg stance and March in place. Resistance exercises include: calf raises, lunges, supine leg curls and extensions.

Primary outcome measure

  • Gait Change [ Time Frame: Change from Baseline to week 16 ]
  • Balance Change [ Time Frame: Change from Baseline to week 16 ]
  • Change in Lower Extremity Muscle Strength [ Time Frame: Change from Baseline to week 16 ]
  • Change in Lower Extremity Nerve Conduction [ Time Frame: Change from Baseline to week 16 ]
  • Change in Neuropathy Symptoms [ Time Frame: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks ]
  • Neuropathy Quality of Life [ Time Frame: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks ]

Central Contacts and Locations

Central contacts

Constance Visovsky

8139743831cvisovsk@usf.edu

Jillian Coury

8139745117coury@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Constance Visovsky

813-974-3831cvisovsk@usf.edu

Jillian Coury

8139745117coury@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Nov 9, 2020

Last verified

Jul, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2020-11-09.