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Exercise Program for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients (B-HAPI Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
B-HAPI Trial 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.Check my eligibility
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.See study design
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.
B-HAPI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
B-HAPI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Balance Change
Change in Lower Extremity Muscle Strength
Change in Lower Extremity Nerve Conduction
+3 moreSecondary outcome measures
Change in Body Mass Index
Accidental Falls
Change in Neuropathic Pain
+1 moreOther outcome measures
Participant age
Taxane cycles
B-HAPI 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.
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Who is running the clinical trial?
University of South FloridaLead Sponsor
407 Previous Clinical Trials
186,497 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
250 Patients Enrolled for Peripheral Neuropathy
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,355 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,473 Patients Enrolled for Peripheral Neuropathy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman over 21 who finished treatment for breast cancer with taxane-based chemotherapy.I have swelling due to lymphedema or my condition puts me at high risk for bone issues.I have a condition like diabetes or HIV that causes nerve damage or muscle weakness.I do not have any health conditions that prevent me from exercising.My nerve pain score is over 3, similar to severe diabetic nerve pain.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Attention Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the limit of participants in this clinical trial?
"Affirmative. Clinicaltrials.gov data highlights that this study, first published on August 14th 2020, is actively recruiting participants. The trial requires 312 volunteers from a single medical facility to participate."
Answered by AI
What results is the research team hoping to achieve with this trial?
"This trial's primary goal is to observe any changes over the course of 16 weeks. Secondary endpoints include monitoring a participant's Body Mass Index, which will be measured using Tanita body composition analyzers; tracking medications used for neuropathic pain and documenting dosage change/no change; and assessing severity of pain, its impact on daily life, location of pain etc., via Brief Pain Inventory."
Answered by AI
Is this investigation looking to enroll new participants?
"Affirmative, the research posted on clinicaltrials.gov implies that this trial is actively accepting participants. After being initially shared on August 14th 2020 and updated most recently on November 5th 2020, 312 recruits are still needed from a singular site."
Answered by AI
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