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Cryotherapy for Peripheral Neuropathy (CONTRoL Trial)

Q: Are individuals over 20 years of age eligible for this research initiative?

This clinical trial is seeking individuals aged 18 to 99 years of age.

Q: Are there any restrictions to join this clinical experiment?

This clinical trial seeks 100 participants suffering from a peripheral nervous system disorder and aged 18 to 99. Applicants must meet the following qualifications: Eastern Cooperative <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A), Age greater or equal to 18 years., Scheduled for at least 12 weeks of adjuvant or neoadjuvant paclitaxel or docetaxel treatment.

Q: Are there any spots still available for participants in this research?

Clinicaltrials.gov confirms that this study is no longer recruiting patients, having been initially posted on April 25th 2019 and last edited July 21st 2022. However, there are currently 161 other trials actively in search of trial participants.

N/A

Waitlist Available

Led By Melissa Accordino, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

CONTRoL Trial Summary

This trial is testing whether cold therapy, compression therapy, or placebo reduces neuropathic pain caused by chemotherapy.

Eligible Conditions

Chemotherapy-induced Peripheral Neuropathy

CONTRoL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Average Time to Complete 'Timed Get up and go' Test

Change in NCI-CTCAE Grade for CIPN

Comfort With Intervention Scale Score

+4 more

CONTRoL Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: CryotherapyActive Control1 Intervention

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.

Group II: Compression TherapyActive Control1 Intervention

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.

Group III: Control arm (Loose glove/sock)Placebo Group1 Intervention

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.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,770 Total Patients Enrolled

2 Trials studying Peripheral Neuropathy

76 Patients Enrolled for Peripheral Neuropathy

Melissa Accordino, MDPrincipal InvestigatorColumbia University

3 Previous Clinical Trials

259 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over 20 years of age eligible for this research initiative?

"This clinical trial is seeking individuals aged 18 to 99 years of age."

Answered by AI

Are there any restrictions to join this clinical experiment?

"This clinical trial seeks 100 participants suffering from a peripheral nervous system disorder and aged 18 to 99. Applicants must meet the following qualifications: Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A), Age greater or equal to 18 years., Scheduled for at least 12 weeks of adjuvant or neoadjuvant paclitaxel or docetaxel treatment."

Answered by AI

Are there any spots still available for participants in this research?

"Clinicaltrials.gov confirms that this study is no longer recruiting patients, having been initially posted on April 25th 2019 and last edited July 21st 2022. However, there are currently 161 other trials actively in search of trial participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL

Melissa K Accordino 2019. "The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03873272.