← Back to Search

Exercise Program for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients (B-HAPI Trial)

N/A

Waitlist Available

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female breast cancer survivors (>21) who completed treatment for invasive breast cancer with taxane-based chemotherapy

Participants with a peripheral neuropathy score of > 3 by VAS rating consistent with studies of diabetic peripheral neuropathy

Must not have

Presence of any disease (e.g. diabetes, HIV) that results in peripheral neuropathy or muscle weakness

Individuals with symptomatic lymphedema or advanced disease at high risk for bone metastases and pathologic fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effects of a 16 week gait/balance training plus resistance exercise program to address persistent taxane-induced peripheral neuropathy in 312 patients treated for breast cancer.

Who is the study for?

This trial is for female breast cancer survivors over 21 who finished taxane-based chemotherapy at least a year ago and are experiencing persistent neuropathy with a pain score of more than 3. It's not for those with other diseases causing neuropathy or muscle weakness, conditions preventing exercise, symptomatic lymphedema, or advanced disease risking bone fractures.

What is being tested?

The study tests a home-based program combining gait/balance training with resistance exercises against an educational control group to improve muscle strength, balance, nerve function, reduce neuropathy symptoms from taxane chemotherapy, and enhance quality of life in participants.

What are the potential side effects?

Since the intervention involves physical activity through gait/balance and resistance exercises at home, potential side effects may include typical exercise-related issues such as muscle soreness or strain. However, serious side effects are unlikely given the non-invasive nature of the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 21 who finished treatment for breast cancer with taxane-based chemotherapy.

Select...

My nerve pain score is over 3, similar to severe diabetic nerve pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a condition like diabetes or HIV that causes nerve damage or muscle weakness.

Select...

I have swelling due to lymphedema or my condition puts me at high risk for bone issues.

Select...

I do not have any health conditions that prevent me from exercising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change over time from baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change over time from baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change over time from baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Balance Change

Change in Lower Extremity Muscle Strength

Change in Lower Extremity Nerve Conduction

+3 more

Secondary study objectives

Change in Body Mass Index

Accidental Falls

Change in Neuropathic Pain

+1 more

Other study objectives

Participant age

Taxane cycles

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Attention Control GroupActive Control1 Intervention

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.

0 / 5Eligibility criteria met