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Exercise + Nutrition Education for Peripheral Neuropathy
Phase 2
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
Be female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
Awards & highlights
Study Summary
This trial is testing whether exercise or nutrition education can help relieve side-effects from chemotherapy-induced peripheral neuropathy, which causes severe pain and numbness.
Who is the study for?
This trial is for women with breast cancer who are about to start taxane chemotherapy. They must be able to read English, be at least 18 years old, and have a life expectancy of at least six months. Participants should not already be active in exercise routines and must not have physical limitations that prevent them from exercising or MRI scans if applicable.Check my eligibility
What is being tested?
The study compares the effects of an exercise program (EXCAP Exercise) versus nutrition education on chemotherapy-induced peripheral neuropathy (CIPN). It aims to understand how these interventions might influence inflammation and body awareness, helping design future studies.See study design
What are the potential side effects?
Since this trial involves exercise and educational interventions rather than drugs, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. There are no drug-related side effects involved.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for taxane chemotherapy without other nerve-damaging treatments.
Select...
I am female.
Select...
I have breast cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)
Secondary outcome measures
Numbness and tingling
Patient-reported sensory symptoms of CIPN
Sensory loss
+1 moreOther outcome measures
Cardiovascular function
Immunological function
Musculoskeletal function
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 Intervention
Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.
Group II: Nutrition EducationActive Control1 Intervention
Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EXCAP Exercise
2017
N/A
~30
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,170 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,086 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,473 Patients Enrolled for Peripheral Neuropathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any conditions that prevent me from having an MRI scan.You are not currently exercising regularly.I have health issues that prevent me from doing intense exercise or walking programs.I am 18 years old or older.I am scheduled for taxane chemotherapy without other nerve-damaging treatments.I am female.I have breast cancer.Your doctor thinks you have at least six months left to live.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise
- Group 2: Nutrition Education
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.
How many individuals can be enrolled in this research endeavor?
"Affirmative. The information available on clinicaltrials.gov reveals that this medical research, which first opened its doors to participants in April of 2019, is currently enrolling patients. 80 individuals are needed at a single site for the trial's completion."
Answered by AI
Are there any unfilled vacancies in this experiment for participants?
"Correct. According to clinicaltrials.gov, this research is actively searching for participants and has been since April 15th 2019. The current version of the trial was last modified on June 30th 2022 - 80 patients are needed from a single site."
Answered by AI
Has EXCAP Exercise been authorized by the FDA?
"The safety of EXCAP Exercise has been assessed as a 2 due to the Phase 2 trial, which indicates that there are preliminary data suggesting it is secure but no clinical trials have yet come out in support of efficacy."
Answered by AI
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