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Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity


N/A
18 Years
N/A
Open (Enrolling)
Female
Chemotherapeutic Agent Toxicity, Pain, Peripheral Neuropathy, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Therapy-related Toxicity

Thank you

Trial Information

Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity


PRIMARY OBJECTIVES: I. Differences in "tingling" and "numbness" (measured on 0-10 numeric
rating scale; as measured by NPSI) between treated and untreated extremities at conclusion
of paclitaxel therapy). SECONDARY OBJECTIVES: I. Differences in nail toxicity between
treated and untreated extremities as measured by NCI-CTC v4.0 from baseline to conclusion of
taxane therapy and at each time point (after each infusion and at conclusion of taxane
therapy). II. Differences in peripheral sensory neuropathy subscale of NCI-CTC v 4.0 between
treated and untreated extremities at each time point (after each infusion and at conclusion
of paclitaxel therapy). III. Differences in pain intensity (0-10 from BPI) between treated
and untreated extremities at each time point (after each infusion and at conclusion of
paclitaxel therapy). IV. Differences in quantitative sensory testing between treated and
untreated extremities at each time point (after each infusion and at conclusion of
paclitaxel therapy). OUTLINE: Patients are randomized to 1of 2 treatment arms. ARM I.
Patients 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: Patients 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. In both arms, treatment repeats every 2 weeks for 4 courses in the
absences of unacceptable toxicity.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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.

Outcome Time Frame:

Periodically during study treatment

Safety Issue:

No

Principal Investigator

Judith Paice, PhD, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

NU 10CC03

NCT ID:

NCT01243541

Start Date:

October 2010

Completion Date:

October 2015

Related Keywords:

  • Chemotherapeutic Agent Toxicity
  • Pain
  • Peripheral Neuropathy
  • Recurrent Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Therapy-related Toxicity
  • Breast Neoplasms
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location

Northwestern UniversityChicago, Illinois  60611