The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL

NCT ID: NCT03873272

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-25
• Study Completion Date: 2023-02-02

Brief 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.

Detailed 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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cryotherapy

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.

Group Type: ACTIVE_COMPARATOR

Cryotherapy

Intervention Type: DEVICE

Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.

Compression Therapy

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.

Group Type: ACTIVE_COMPARATOR

Compression Therapy

Intervention Type: DEVICE

Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.

Control arm (Loose glove/sock)

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.

Group Type: PLACEBO_COMPARATOR

Loose glove/sock

Intervention Type: DEVICE

Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.

Interventions

Cryotherapy

Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.

Intervention Type: DEVICE

Compression Therapy

Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.

Intervention Type: DEVICE

Loose glove/sock

Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Melissa K Accordino

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Accordino, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

References

Accordino MK, Lee S, Leu CS, Levin B, Trivedi MS, Crew KD, Kalinsky K, Raghunathan R, Faheem K, Harden E, Taboada A, de Oliveira BD, Larson E, Franks L, Honan E, Law C, Hershman DL. Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer. Breast Cancer Res Treat. 2024 Feb;204(1):49-59. doi: 10.1007/s10549-023-07172-y. Epub 2023 Dec 7.

Reference Type: DERIVED

PMID: 38060077 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAR9515

Identifier Type: -

Identifier Source: org_study_id