Purpose

This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Studying certain risk factors, such as age, gender, pre-existing conditions, and the type of treatment for cancer may help doctors estimate how likely patients are to develop the nerve disorder.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


Inclusion Criteria:

- Patients must have stage I, II, or III primary non-small cell lung, primary breast, or
primary ovarian cancer based on clinical or pathologic evaluation. Patients with Stage
IV disease are not eligible.

- Patients must be planning to start treatment with a taxane-based chemotherapy as part
of one of the study-approved taxane regimens (docetaxel chemotherapy regimens for
treatment of breast or ovarian cancer, or paclitaxel chemotherapy regimen for
treatment of breast, non-small cell lung, or ovarian cancer) within 14 days after
registration. (Note that docetaxel or paclitaxel may be administered with a
non-neurotoxic chemotherapy, such as cyclophosphamide, and/or biologic agent, such as
trastuzumab, and/or carboplatin. Additionally, nab-paclitaxel may not be substituted
for paclitaxel for purposes of this study.)

- Patients who will receive treatment in the setting of any other clinical trial are
eligible as long as it is one of the study-approved regimens. Patients may receive
additional treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as
part of another clinical trial in addition to any regimen approved in this study.

- Patients must not have received a taxane (paclitaxel, docetaxel, or protein-bound
paclitaxel), platinum (cisplatin, carboplatin, or oxaliplatin), vinca alkaloid
(vinblastine, vincristine, or vinorelbine), or bortezomib-based chemotherapy regimen
prior to registration. (Note that while patients must not have received carboplatin in
the past, patients may receive a carboplatin-containing regimen after registration as
part of the docetaxel or paclitaxel regimen.)

- Patients who can complete Patient-Reported Outcome (PRO) instruments in English or
Spanish must:

- Agree to complete PROs at all scheduled assessments

- Complete the baseline PRO forms prior to registration

- Patients with pre-existing neuropathy are eligible, including those with diabetes and
neurological conditions such as multiple sclerosis or Parkinson?s disease.

- Patients must agree to submit required specimens for defined translational medicine.

- Patients must be offered the opportunity to submit additional optional specimens for
future, unspecified translational medicine and banking. With patient?s consent,
specimens must be submitted.

- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines.

- As a part of the OPEN registration process the treating institution's identity is
provided in order to ensure that the current (within 365 days) date of institutional
review board approval for this study has been entered in the system.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Observational (non-study chemo, questionnaire, assessments) Patients receive chemotherapy regimen per treating physician for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires at weeks 4, 8, 12, 24 and 52.
  • Drug: Chemotherapy
    Given chemotherapy regimen
    Other names:
    • Chemo
    • Chemotherapy (NOS)
    • Chemotherapy, Cancer, General
  • Other: Functional Assessment
    Functional and sensory clinician assessments
  • Other: Questionnaire Administration
    Patient and physician reported responses

Recruiting Locations

Tulane University Health Sciences Center
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-988-6121

More Details

Status
Recruiting
Sponsor
Southwest Oncology Group

Study Contact

Detailed Description

PRIMARY OBJECTIVES: I. To develop and validate a clinical risk prediction model using clinical factors for the development of peripheral neuropathy in patients receiving taxane-based chemotherapy regimens. SECONDARY OBJECTIVES: I. To examine patient-reported outcomes (PROs) and objective measures of chemotherapy induced peripheral neuropathy (CIPN) to better define the phenotype of peripheral neuropathy in this patient population. II. To assess the incidence of CIPN within one year in this patient population. III. To identify predictors of treatment dose reductions, delays, and discontinuations associated with CIPN symptoms in this patient population. OTHER OBJECTIVES: I. To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN. OUTLINE: Patients receive chemotherapy regimen per treating physician for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires at weeks 4, 8, 12, 24 and 52.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.