N/A Completed N=63 Randomized Prevention

The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Source: ClinicalTrials.gov NCT03873272 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

May 2023

Primary outcomePrimary: Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline) — 0.45; 0.59; 0.52 Proportion of Patients

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.

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	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.