Heading Off Peripheral Neuropathy With Exercise (NCT00869804) | Clinical Trial Compass
TerminatedNot Applicable
Heading Off Peripheral Neuropathy With Exercise
Stopped: Could not recruit total numbers needed. PI left institution.
United States19 participantsStarted 2009-03-25
Plain-language summary
Chemotherapy for the treatment of breast cancer can affect nerves and muscles leading to loss of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle weakness. This study will explore if exercises such as walking and strength training may prove helpful in preventing or lessening chemotherapy-induced peripheral neuropathy from chemotherapy, making the therapy easier to tolerate and increasing overall quality of life.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 19 or older with newly diagnosed Stage I-IIIa invasive breast cancer who are to be treated with a taxane-based chemotherapy regimen (with paclitaxel or docetaxel) and thus are at risk for the development of CIPN.
Exclusion Criteria:
* any disease (e.g. diabetes, HIV) that results in peripheral neuropathy;
* any disease or disorder that results in muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke, preexisting cardiopulmonary disease);
* any disease or disorder that would preclude strength training exercises (such as bone metastasis, osteoporosis);
* individuals with diagnosed lymphedema or advanced disease (\> Stage IIIa, or metastatic disease) at high risk for bone metastases and pathologic fracture will be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — do you know why it was stopped, and does that affect how much we can trust any findings about exercise reducing neuropathy symptoms from chemotherapy?
2Since the trial was specifically looking at exercise as a way to prevent or reduce neuropathic symptoms during breast cancer chemotherapy, is there any current evidence from other completed studies that would tell us whether exercise actually helps with chemo-related nerve damage?
3The trial was listed as Phase NA, which suggests it may have been a very early or pilot study — does that mean the approach of using exercise for neuropathy prevention is still largely experimental, and should I be cautious about relying on it as a strategy?
4Given that this study was terminated and may not have produced clear results on the effect size for reducing neuropathic symptoms, what other proven options do we have to help manage or prevent peripheral neuropathy if I need chemotherapy?
5If exercise was being studied as a supportive care strategy alongside chemotherapy for breast cancer, is it still something you'd recommend I try, even without a completed trial behind it, and are there any risks to exercising during my treatment that I should know about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.