N/A
N=63
The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT03873272 ↗Enrolled (actual)
63
Serious AEs
11.1%
Results posted
May 2023
Primary outcome: Primary: Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline) — 0.45; 0.59; 0.52 Proportion of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryotherapy (Device); Compression Therapy (Device); Loose glove/sock (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline) |
0.45; 0.59; 0.52 | — |
| SECONDARY Change in NCI-CTCAE Grade for CIPN |
1; 0; 1; 10; 8; 7 | — |
| SECONDARY Change in Nail Toxicity |
0; 0; 1; 10; 7; 10 | — |
| SECONDARY Comfort With Intervention Scale Score |
4; 2; 0; 0; 0; 1 | — |
| SECONDARY Vibration Perception and Disappearance Threshold |
10.95; 7.70; 8.47; 20.55; 17.16; 13.29 | — |
| SECONDARY Subjects Perceived Pain and Pressure Using Neuropen Test |
3; 0; 0; 11; 18; 13 | — |
| SECONDARY Average Time to Complete 'Timed Get up and go' Test |
15.48; 12.36; 15.18; 17.45; 13.93; 14.84 | — |
| SECONDARY Tandem and Unipedal Stance Test |
6; 12; 11; 7; 7; 4 | — |
| SECONDARY Adherence to Study Intervention |
7; 16; 16; 13; 6; 5 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03873272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.