The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL

NCT03873272 | Completed Results DMC FDA Device

• 1 other identifier: AAAR9515
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Keywords

Neuropathy; CIPN; Cryotherapy; Compression therapy

Outcome Measures

Primary Outcomes (1)

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

  The primary endpoint is the change in FACT NTX at 12 weeks from the start of chemotherapy. The change in FACT NTX will be dichotomized into a good outcome (change in FACT NTX less than 5 from baseline to week 12) versus a poor outcome (change in FACT NTX greater than or equal to 5 from baseline to week 12). The FACT-NTX subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. The scale is graded 0-4. A low score indicates a good effect. This change in FACT-NTX scale score indicates the proportion of patients with successful outcomes.

  Baseline, 12 weeks

Secondary Outcomes (8)

• Change in NCI-CTCAE Grade for CIPN

  Baseline, 12, and 24 weeks

• Change in Nail Toxicity

  Baseline, 12 weeks, 24 weeks

• Comfort With Intervention Scale Score

  Up to 24 weeks

• Vibration Perception and Disappearance Threshold

  Up to 24 weeks

• Subjects Perceived Pain and Pressure Using Neuropen Test

  Up to 24 weeks

Study Arms (3)

Cryotherapy

ACTIVE COMPARATOR

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.

Device: Cryotherapy

Compression Therapy

ACTIVE COMPARATOR

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.

Device: Compression Therapy

Control arm (Loose glove/sock)

PLACEBO COMPARATOR

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.

Device: Loose glove/sock

Interventions

Cryotherapy 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.

Cryotherapy

Compression Therapy 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.

Compression Therapy

Loose glove/sock 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.

Control arm (Loose glove/sock)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%,)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 38060077 DERIVED

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Melissa Accordino, MD
• Organization: Columbia University Irving Medical Center

mkg2134@cumc.columbia.edu

646-317-4692

Study Officials

• Melissa Accordino, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: The preferred intervention can be selected during the ongoing enrollment as soon as the pre-specified selection criteria are met, and further enrollment will cease.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 13, 2019
• Study Start: April 25, 2019
• Primary Completion: September 12, 2022
• Study Completion: February 2, 2023
• Last Updated: October 3, 2024
• Results First Posted: May 25, 2023

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)