The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL

Columbia University

Status: Completed

Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy

Treatments: Device: Compression Therapy; Device: Cryotherapy; Device: Loose glove/sock

Study type: Interventional

Funder types: Other

Identifiers

NCT03873272

AAAR9515

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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63 participants in 3 patient groups, including a placebo group

Cryotherapy

Active Comparator group

Description:

Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.

Treatment:

Device: Cryotherapy

Compression Therapy

Active Comparator group

Description:

Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.

Treatment:

Device: Compression Therapy

Control arm (Loose glove/sock)

Placebo Comparator group

Description:

Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.

Treatment:

Device: Loose glove/sock