Study Stopped
PI decision due to low accrual and lack of funding
Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity
3 other identifiers
interventional
33
1 country
1
Brief Summary
RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving paclitaxel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2010
CompletedStudy Start
First participant enrolled
November 3, 2010
CompletedFirst Posted
Study publicly available on registry
November 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2014
CompletedAugust 20, 2019
August 1, 2019
3.4 years
October 29, 2010
August 16, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
To assess the primary aim of the study to determine the differences in "tingling" and "numbness" (measured on a 0-10 numeric rating scale) between the treated and untreated extremities.
Periodically during study treatment
To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater.
After completion of study treatment
Secondary Outcomes (1)
To compare the treated and untreated extremities at each time point with respect to the ratings in regards to the NCI-CTC v4.0, BPI, and QSTs.
Periodically during study treatment
Study Arms (2)
Arm I
EXPERIMENTALPatients wear an Elasto-Gel cold glove and sock on their dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel.The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes.
Arm II
EXPERIMENTALPatients wear an Elasto-Gel cold glove and sock on their non-dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel. The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes.
Interventions
Ancillary studies
In this therapeutic study, cold therapy is administered with an Elasto-Gel cold glove and sock (study device) that will be worn on your right hand and foot or your left hand and foot. The study device is a glycerine-based gel cold pack shaped like a mitten or sock with a cloth-like fabric kept at a constant temperature. The study device is not known to cause any major adverse affects and it is considered of non-significant risk. If you choose to participate in this study, you will be asked to wear a glove and sock at each paclitaxel infusion (4 treatments total). We hope the use of this study device will prevent or significantly reduce the onset and potential severity of paclitaxel-induced peripheral neuropathy and nail problems.
Study Treatment Assessment You will be asked permission for pictures to be taken of only your hands and feet. This is to have a visual documentation of symptom development during your treatment. This will be done at all six time points before you begin chemotherapy that day.
Eligibility Criteria
You may qualify if:
- Women with histologically confirmed diagnosis of breast cancer (any stage)
- Must be receiving either adjuvant or neo-adjuvant dose-dense anthracycline/taxane-based chemotherapy
- Specifically, this study seeks to characterize neuropathies associated with patients receiving paclitaxel cycles separated by two week intervals
- Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation
- Prior chemotherapies are permitted, except with prior treatments with taxanes
- Required lab values: CBC, Comprehensive Chemistry Panel
- Desired lab values: If the patient's record also includes TSH, HbA1c, and folate, then those will be recorded as well
- All patients will have given signed, informed consent prior to registration
You may not qualify if:
- Patients must not have received any prior taxane treatments
- Patients must not have a history of peripheral neuropathy (regardless of cause)
- Patient must not have a history of diabetes mellitus
- Patient must not have a history of Raynaud's disease
- Men are not eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judith Paice, PhD, RN
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 18, 2010
Study Start
November 3, 2010
Primary Completion
April 4, 2014
Study Completion
April 4, 2014
Last Updated
August 20, 2019
Record last verified: 2019-08