Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer

  • STATUS
    Recruiting
  • End date
    Feb 28, 2026
  • participants needed
    1050
  • sponsor
    Southwest Oncology Group
Updated on 17 November 2020
Investigator
Site Public Contact
Primary Contact
University of Maryland Shore Medical Center at Easton (58.4 mi away) Contact
+103 other location
diabetes
paclitaxel
cancer
cyclophosphamide
oxaliplatin
carboplatin
chemotherapy regimen
docetaxel
aspart
neuropathy
cancer chemotherapy
investigational therapy
ovarian cancer
vinorelbine
taxane
biologics
tingling

Summary

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.

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.

Details
Treatment questionnaire administration, Chemotherapy, Functional Assessment
Clinical Study IdentifierNCT03939481
SponsorSouthwest Oncology Group
Last Modified on17 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Lung Non-Small Cell Carcinoma or Prognostic Stage IB Breast Cancer AJCC v8 or Stage IIIC Ovarian Cancer AJCC v8 or Stage IIIA Ovarian Cancer AJCC v8 o...?
Do you have any of these conditions: Stage II Lung Cancer AJCC v8 or Anatomic Stage IA Breast Cancer AJCC v8 or Stage IIIB Lung Cancer AJCC v8 or Lung Non-Small Cell Carcinoma or Anatomic...?
Do you have any of these conditions: Stage IIB Lung Cancer AJCC v8 or Anatomic Stage IIIA Breast Cancer AJCC v8 or Prognostic Stage IB Breast Cancer AJCC v8 or Stage IIIA2 Ovarian Cancer ...?
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
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