The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL

  • STATUS
    Recruiting
  • days left to enroll
    61
  • participants needed
    100
  • sponsor
    Columbia University
Updated on 24 January 2021
paclitaxel
cancer
breast cancer
docetaxel
cancer treatment
taxane
neuralgia
peripheral neurotoxicity

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.

Description

Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent side effect resulting from the administration of cytotoxic chemotherapeutic agents. The incidence of CIPN can vary on the type of agent used, the frequency with which it is given, and the cumulative dose. Unfortunately, for some patients, symptoms may persist even after discontinuation of the drug due to irreversible nerve damage. As of now, there are no established agents for CIPN prevention.

This is a randomized, placebo-controlled clinical selection trial of interventions for CIPN in patients treated with docetaxel every 3 weeks or paclitaxel on a weekly schedule. Patients will be randomly assigned to receive either frozen gloves and socks, compression gloves and socks, or "loose" gloves and socks (placebo arm) during chemotherapy infusion to study the best intervention at reducing neuropathic pain.

Details
Condition CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
Treatment Cryotherapy, Compression therapy, Loose glove/sock
Clinical Study IdentifierNCT03873272
SponsorColumbia University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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%, see Appendix A)

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)
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