Home-Based Physical Activity Intervention for Taxane-Induced CIPN

NCT04621721 | Unknown DMC

• 2 other identifiers: Pro000400351R01CA229681-01A1
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (6)

• Gait Change

  Gait analysis will be performed using a GAITRite System with 3D motion capture with integrated force platform. Gait variables to be used in analysis are ankle plantar/flexor torque

  Change from Baseline to week 16

• Balance Change

  Balance analysis will be performed using the Neurocom Balance Master Sensory Organization Test

  Change from Baseline to week 16

• Change in Lower Extremity Muscle Strength

  Isokinetic dynamometry (Biodex 3.0) Hip flexors, hip abductors, knee flexors, knee extensors, and ankle dorsiflexors will be tested

  Change from Baseline to week 16

• Change in Lower Extremity Nerve Conduction

  Nerve conduction studies of the sural \& peroneal nerve action potentials will be tested by Dr. Vu, USF Department of Neurology.

  Change from Baseline to week 16

• Change in Neuropathy Symptoms

  FACT-Taxane Additional Concerns subscale53 Addresses symptoms specific to neuropathy. Likert scale: 0 (not at all) - 4 (very much).

  Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks

• Neuropathy Quality of Life

  FACT-Taxane (version 4) 54 A total Quality of Life score can be obtained by summing the subscale scores and will be used for in the data analysis.

  Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Secondary Outcomes (4)

• Change in Neuropathic Pain

  Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks

• Change in Body Mass Index

  Change from Baseline to week16

• Change in Neuropathy or Pain Medications

  Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks

• Change in Falls or near falls in last month

  Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Other Outcomes (2)

• Participant age

  Baseline

• Taxane cycles

  Baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Gait/balance & resistive exercise

Attention Control Group

ACTIVE COMPARATOR

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.

Behavioral: Gait/balance & resistive exercise

Interventions

Gait/balance & resistive exercise BEHAVIORAL

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.

Attention Control Group; Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female breast cancer survivors age 21 and above
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (2)

• Ozorio Dutra SV, Schwab L, Coury J, Ji M, Visovsky C. Process evaluation protocol plan for a home-based physical activity intervention versus educational intervention for persistent taxane-induced peripheral neuropathy (B-HAPI study): a randomized controlled trial. BMC Cancer. 2024 Jun 27;24(1):777. doi: 10.1186/s12885-024-12444-x.

  PMID: 38937667 DERIVED

• Teran-Wodzinski P, Haladay D, Vu T, Ji M, Coury J, Adams A, Schwab L, Visovsky C. Assessing gait, balance, and muscle strength among breast cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): study protocol for a randomized controlled clinical trial. Trials. 2022 Apr 27;23(1):363. doi: 10.1186/s13063-022-06294-w.

  PMID: 35477489 DERIVED

MeSH Terms

Conditions

Gait Disorders, Neurologic; Muscle Weakness

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathologic Processes

Central Study Contacts

Constance Visovsky

CONTACT

8139743831; cvisovsk@usf.edu

Jillian Coury

CONTACT

8139745117; coury@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the investigator, co-investigators, statistician and data collectors will be blinded to study assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: November 9, 2020
• Study Start: August 14, 2020
• Primary Completion: July 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)