Prevention of Paclitaxel Neuropathy With Cryotherapy

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Oncology & Hematology Associates of Northern Virginia
• Collaborator: Inova Health System
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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.