Trial Outcomes & Findings for Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose (NCT NCT02283983)

Last Updated: 2024-10-09

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

319 participants

Primary outcome timeframe

8 weeks post infusion of docetaxel

Results posted on

2024-10-09

Of 319 enrolled participants, 280 met inclusion criteria and were randomized to treatment

Participant milestones
Measure	Cryoprotection With Mittens and Booties Standard cryoprotection with mittens and booties mittens and booties cooling helmet	Standard Cryoprotection Proposal helmet without mittens and booties cooling helmet
Overall Study STARTED	141	139
Overall Study COMPLETED	123	120
Overall Study NOT COMPLETED	18	19

Reasons for withdrawal
Measure	Cryoprotection With Mittens and Booties Standard cryoprotection with mittens and booties mittens and booties cooling helmet	Standard Cryoprotection Proposal helmet without mittens and booties cooling helmet
Overall Study Inclusion criteria not met	0	1
Overall Study Withdrawal by Subject	4	2
Overall Study Protocol Violation	0	4
Overall Study Physician Decision	2	4
Overall Study Death	1	0
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	9	8
Overall Study Relapse	1	0

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Cryoprotection With Mittens and Booties n=141 Participants Standard cryoprotection with mittens and booties mittens and booties cooling helmet	Standard Cryoprotection n=133 Participants Proposal helmet without mittens and booties cooling helmet	Total n=274 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 11 • n=141 Participants	54 years STANDARD_DEVIATION 12 • n=133 Participants	54 years STANDARD_DEVIATION 11 • n=274 Participants
Sex: Female, Male Female	141 Participants n=141 Participants	133 Participants n=133 Participants	274 Participants n=274 Participants
Sex: Female, Male Male	0 Participants n=141 Participants	0 Participants n=133 Participants	0 Participants n=274 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

Timeframe: 8 weeks post infusion of docetaxel

Population: Intention-to-treat analysis. 6 patients removed from the analysis because no taxotere treatment was performed.

Outcome measures
Measure	Cryoprotection With Mittens and Booties n=141 Participants Standard cryoprotection with mittens and booties mittens and booties cooling helmet	Standard Cryoprotection n=133 Participants Proposal helmet without mittens and booties cooling helmet
Evaluation of the Occurrence of Nail Toxicity of Grade 2 of Common Toxicity Criteria for Adverse Effects V4.0 Evaluated at 8 Weeks Post Infusion of Docetaxel.	26 Participants	49 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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