TerminatedNot Applicable

Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel

Stopped: PI decision due to low accrual and lack of funding

United States33 participantsStarted 2010-11-03

Plain-language summary

RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving paclitaxel.

Who can participate

Age range

18 Years

Sex

FEMALE

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: * Women with histologically confirmed diagnosis of breast cancer (any stage) * Must be receiving either adjuvant or neo-adjuvant dose-dense anthracycline/taxane-based chemotherapy * Specifically, this study seeks to characterize neuropathies associated with patients receiving paclitaxel cycles separated by two week intervals * Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation * Prior chemotherapies are permitted, except with prior treatments with taxanes * Required lab values: CBC, Comprehensive Chemistry Panel * Desired lab values: If the patient's record also includes TSH, HbA1c, and folate, then those will be recorded as well * All patients will have given signed, informed consent prior to registration Exclusion Criteria: * Patients must not have received any prior taxane treatments * Patients must not have a history of peripheral neuropathy (regardless of cause) * Patient must not have a history of diabetes mellitus * Patient must not have a history of Raynaud's disease * Men are not eligible

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

To assess the primary aim of the study to determine the differences in "tingling" and "numbness" (measured on a 0-10 numeric rating scale) between the treated and untreated extremities.

Timeframe: Periodically during study treatment

To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater.

Timeframe: After completion of study treatment

Trial details

NCT IDNCT01243541

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04-04

View on ClinicalTrials.gov More Chemotherapeutic Agent Toxicity trials