CompletedNot Applicable

The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL

United States63 participantsStarted 2019-04-25

Plain-language summary

The primary objective of this study is to select the best intervention from cold therapy, compression therapy and placebo at reducing neuropathic pain as measured by the change in the Neurotoxicity (NTX) component of the Functional Assessment of Cancer Therapy (FACT) - Taxane questionnaire, following 12 weeks of neoadjuvant/adjuvant chemotherapy with paclitaxel or docetaxel among breast cancer patients.

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age greater or equal to 18 years. * History of stage I-III breast cancer * Patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks * Signed informed consent * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%,) Exclusion Criteria: * Prior treatment with taxane or platinum based chemotherapy * Known history of neuropathy * Raynaud's phenomenon * Peripheral arterial ischemia * Cold intolerance * Current use of duloxetine which may mitigate chemotherapy-induced peripheral neuropathy (CIPN)

What they're measuring

Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline)

Timeframe: Baseline, 12 weeks

Trial details

NCT IDNCT03873272

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-12

Results submitted2023-04-28

View on ClinicalTrials.gov More CIPN - Chemotherapy-Induced Peripheral Neuropathy trials