NCT04632797

Brief Summary

This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes. Patients who are not eligible for either cryocompression or cryotherapy are included in a control group. The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2024

Completed
Last Updated

November 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

October 21, 2020

Last Update Submit

November 16, 2020

Conditions

Chemotherapy-induced Peripheral NeuropathyChemotherapeutic ToxicityChemotherapeutic Agent Toxicity

Keywords

Breast CancerCervix CancerEndometrium CancerOvarial CancerCIPNTaxane

Outcome Measures

Primary Outcomes (6)

  • NCV (nerve conduction velocity)

    Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°

    4 years

  • CTCAE 4.03

    Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°

    4 years

  • SWME (Semmes Weinstein monofilament examination)

    Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°

    4 years

  • tuning-fork-test

    Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°

    4 years

  • EORTC QoLCIPN20

    Patient-reported outcomes (PRO)

    4 years

  • Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)

    Patient-reported outcomes (PRO)

    4 years

Secondary Outcomes (2)

  • National Cancer Institute Common Toxicity Criteria version 2

    4 years

  • time frame until polyneuopathy occurs

    4 years

Study Arms (2)

Cryocompression

ACTIVE COMPARATOR

Patients in this group receive cryocompression for the hands.

Device: Hilotherm Chemo Care

Cryotherapy

ACTIVE COMPARATOR

Patients in this group receive cryotherapy for the hands.

Device: Hilotherm Chemo Care

Interventions

Hilotherm Chemo CareDEVICE

Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.

CryocompressionCryotherapy

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with breast cancer or other gynecological tumors
  • planned neoadjuvant, adjuvant or palliative chemotherapy
  • \</= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line)
  • at least three cycles of chemotherapy with taxanes
  • written consent
  • years and older

You may not qualify if:

  • PNP \>/= 2
  • neuralgia
  • metastases in bones, metastases in soft tissue (located in skin, hands or feet)
  • Raynaud syndrome
  • peripheral arterial ischemia
  • hand-feet syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Christine Brunner

    Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Brunner

CONTACT

+4351250481194c.brunner@tirol-kliniken.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
It is an observer blinded study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1 to 1 randomization in either cryocompression or cryotherapy of the hands
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2020

First Posted

November 17, 2020

Study Start

February 3, 2020

Primary Completion

February 3, 2022

Study Completion

February 3, 2024

Last Updated

November 17, 2020

Record last verified: 2020-02

Locations

AU(1)