Prevention of Paclitaxel Neuropathy With Cryotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cryotherapy

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.

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type OTHER

Paclitaxel

Intervention Type DRUG

Interventions

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Cryotherapy

Intervention Type OTHER

Paclitaxel

Intervention Type DRUG

Other Intervention Names

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Cold therapy Elasto gel™ Taxol Taxanes

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No