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Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy, Chemotherapeutic Toxicity, Chemotherapeutic Agent Toxicity

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hilotherm Chemo Care
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Breast Cancer, Cervix Cancer, Endometrium Cancer, Ovarial Cancer, CIPN, Taxane

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 18 years and older

Exclusion Criteria:

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

Sites / Locations

  • Medical University InnsbruckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cryocompression

Cryotherapy

Arm Description

Patients in this group receive cryocompression for the hands.

Patients in this group receive cryotherapy for the hands.

Outcomes

Primary Outcome Measures

NCV (nerve conduction velocity)
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
CTCAE 4.03
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
SWME (Semmes Weinstein monofilament examination)
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
tuning-fork-test
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
EORTC QoLCIPN20
Patient-reported outcomes (PRO)
Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)
Patient-reported outcomes (PRO)

Secondary Outcome Measures

National Cancer Institute Common Toxicity Criteria version 2
Changes of nails
time frame until polyneuopathy occurs
time frame until polyneuopathy occurs whilst receiving Taxanes

Full Information

First Posted
October 21, 2020
Last Updated
November 16, 2020
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT04632797
Brief Title
Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy
Official Title
CROPSI Study A Randomized, Observer-blinded Clinical Trial Evaluating Effectiveness of Cryotherapy vs. Cryocompression for Preventing CIPN in Women Undergoing Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
February 3, 2022 (Anticipated)
Study Completion Date
February 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In this randomized, observer blinded, monocentric study 196 patients will be included in a four years period. The patients will be 1 to 1 randomized in either cryocompression or cryotherapy. Patients who are not eligible for either cryocompression or cryotherapy will be included in the control group. Additionally every patient (excluding the control group) receives cryotherapy for the feet. Before receiving the first chemotherapy CTCAE, Semmes-Weinstein monofilament examination (SWME), vibration test for hand and feet, and nerve conduction velocity (NCV) only for hands.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Chemotherapeutic Toxicity, Chemotherapeutic Agent Toxicity
Keywords
Breast Cancer, Cervix Cancer, Endometrium Cancer, Ovarial Cancer, CIPN, Taxane

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1 to 1 randomization in either cryocompression or cryotherapy of the hands
Masking
None (Open Label)
Masking Description
It is an observer blinded study.
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryocompression
Arm Type
Active Comparator
Arm Description
Patients in this group receive cryocompression for the hands.
Arm Title
Cryotherapy
Arm Type
Active Comparator
Arm Description
Patients in this group receive cryotherapy for the hands.
Intervention Type
Device
Intervention Name(s)
Hilotherm Chemo Care
Intervention Description
Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.
Primary Outcome Measure Information:
Title
NCV (nerve conduction velocity)
Description
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Time Frame
4 years
Title
CTCAE 4.03
Description
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Time Frame
4 years
Title
SWME (Semmes Weinstein monofilament examination)
Description
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Time Frame
4 years
Title
tuning-fork-test
Description
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Time Frame
4 years
Title
EORTC QoLCIPN20
Description
Patient-reported outcomes (PRO)
Time Frame
4 years
Title
Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)
Description
Patient-reported outcomes (PRO)
Time Frame
4 years
Secondary Outcome Measure Information:
Title
National Cancer Institute Common Toxicity Criteria version 2
Description
Changes of nails
Time Frame
4 years
Title
time frame until polyneuopathy occurs
Description
time frame until polyneuopathy occurs whilst receiving Taxanes
Time Frame
4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 18 years and older Exclusion Criteria: PNP >/= 2 neuralgia metastases in bones, metastases in soft tissue (located in skin, hands or feet) Raynaud syndrome peripheral arterial ischemia hand-feet syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Brunner
Phone
+4351250481194
Email
c.brunner@tirol-kliniken.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Brunner
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy

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