Clinical trial · Interventional
The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL
Randomized Controlled Selection Trial of Cryotherapy vs. Compression Therapy for the Prevention of Taxane-induced Peripheral Neuropathy in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CIPN - Chemotherapy-Induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression Therapy | Device | — | UNRESOLVED |
| Cryotherapy | Device | — | UNRESOLVED |
| Loose glove/sock | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Cryotherapy
- 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.
- interventionNames
- Device: Cryotherapy
- type
- ACTIVE_COMPARATOR
- label
- Compression Therapy
- 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.
- interventionNames
- Device: Compression Therapy
- type
- PLACEBO_COMPARATOR
- label
- Control arm (Loose glove/sock)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDAccordino 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