Prevention of Paclitaxel Neuropathy With Cryotherapy

Breast Cancer Clinical Trial

Official title:

Prevention of Paclitaxel Neuropathy With Cryotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02230319
• Other study ID #: 2014.1
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 25, 2014
• Last updated: September 30, 2015
• Start date: October 2014
• Est. completion date: March 2017

Study information

• Verified date: September 2015
• Source: Medical Oncology & Hematology Associates of Northern Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: March 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Women 18 years of age or older

2. Histologically or cytological proven diagnosis of breast cancer Stage I- III.

3. Must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting.

4. May have received prior treatment including, radiation, surgery chemotherapy hormone and biologics.

5. Eastern Cooperative Oncology Group (ECOG) performance status = 1

6. Patient signed informed consent.

7. Patient willing and able to comply with scheduled visits and treatment plan.

Exclusion Criteria

1. Patient presents with Grade 2 or greater peripheral neuropathy.

2. History of Raynaud's Disease.

3. Patient presents open or poorly-healing wounds on the hands or feet.

4. Patients with cold intolerance.

5. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Cryotherapy

Drug:
• Paclitaxel

Locations

Country	Name	City	State
United States	Medical Oncology & Hematology Associates of Northern Virginia	Fairfax	Virginia
United States	Medical Oncology & Hematology Associates of Northern Virginia	Reston	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Medical Oncology & Hematology Associates of Northern Virginia	Inova Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.		From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.	No
Secondary	Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.		From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.	No