Prevention of Paclitaxel Neuropathy With Cryotherapy

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02230319

Enrollment

Registered

2014-09-03

Start date

2014-10-31

Completion date

2017-03-31

Last updated

2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Cryotherapy, Cold therapy, Peripheral Neuropathy, Paclitaxel, Breast Cancer, Symptom management, Prevention

Brief summary

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

Interventions

OTHERCryotherapy

DRUGPaclitaxel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.

Secondary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026