Prevention of Paclitaxel Neuropathy With Cryotherapy

Medical Oncology & Hematology Associates of Northern Virginia

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Paclitaxel; Other: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02230319

2014.1

Details and patient eligibility

About

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

Enrollment: 39 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Cryotherapy

Experimental group

Description:

Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes.

Treatment:

Other: Cryotherapy

Drug: Paclitaxel