The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/15/2019 |
| Start Date: | April 2019 |
| End Date: | December 2021 |
| Contact: | Lisa Olmos, RN |
| Email: | cancerclinicaltrials@cumc.columbia.edu |
| Phone: | 212-342-5162 |
Randomized Controlled Selection Trial of Cryotherapy vs. Compression Therapy for the Prevention of Taxane-induced Peripheral Neuropathy in Breast Cancer Patients
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.
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.
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.
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.
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.
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.
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)
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Melissa Accordino, MD
Phone: 212-305-1945
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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