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Clinical Trials in Mexico / NCT03939481
Active, not recruiting Observational

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

NCT03939481 · tracked via the Priya Life Science Mexico tracker
Phase
Observational
Started
2019-05-14
Last updated
2026-06-08

Condition(s) studied

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Lung Non-Small Cell CarcinomaPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Stage I Lung Cancer AJCC v8Stage I Ovarian Cancer AJCC v8Stage IA Ovarian Cancer AJCC v8Stage IA1 Lung Cancer AJCC v8Stage IA2 Lung Cancer AJCC v8Stage IA3 Lung Cancer AJCC v8Stage IB Lung Cancer AJCC v8Stage IB Ovarian Cancer AJCC v8Stage IC Ovarian Cancer AJCC v8Stage II Lung Cancer AJCC v8Stage II Ovarian Cancer AJCC v8Stage IIA Lung Cancer AJCC v8Stage IIA Ovarian Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage IIB Ovarian Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8

Investigational drug(s) / intervention(s)

ChemotherapyFunctional AssessmentQuestionnaire Administration

Chemotherapy: Given chemotherapy regimen

Functional Assessment: Functional and sensory clinician assessments

Questionnaire Administration: Patient and physician reported responses

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (169)

FacilityCityRegionStatus
Kaiser Permanente-Deer Valley Medical Center Antioch California
Kaiser Permanente Dublin Dublin California
Kaiser Permanente-Fremont Fremont California
Kaiser Permanente-Fresno Fresno California
Kaiser Permanente-Oakland Oakland California
Desert Regional Medical Center Palm Springs California
Kaiser Permanente-San Francisco San Francisco California
Kaiser Permanente-Santa Teresa-San Jose San Jose California
Kaiser Permanente San Leandro San Leandro California
Kaiser San Rafael-Gallinas San Rafael California
Kaiser Permanente Medical Center - Santa Clara Santa Clara California
Kaiser Permanente-Santa Rosa Santa Rosa California
Kaiser Permanente Medical Center-Vacaville Vacaville California
Kaiser Permanente-Vallejo Vallejo California
Kaiser Permanente-Walnut Creek Walnut Creek California
Rocky Mountain Regional VA Medical Center Aurora Colorado
Bayhealth Hospital Kent Campus Dover Delaware
Bayhealth Hospital Sussex Campus Milford Delaware
Florida Gynecologic Oncology Fort Myers Florida
Regional Cancer Center-Lee Memorial Health System Fort Myers Florida
Sacred Heart Hospital Pensacola Florida
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
Straub Clinic and Hospital Honolulu Hawaii
University of Hawaii Cancer Center Honolulu Hawaii
Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
Kapiolani Medical Center for Women and Children Honolulu Hawaii
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
Hawaii Cancer Care - Savio ‘Aiea Hawaii
Pali Momi Medical Center ‘Aiea Hawaii
Centralia Oncology Clinic Centralia Illinois
Carle on Vermilion Danville Illinois
Cancer Care Specialists of Illinois - Decatur Decatur Illinois
Decatur Memorial Hospital Decatur Illinois
Carle Physician Group-Effingham Effingham Illinois
Crossroads Cancer Center Effingham Illinois
Little Company of Mary Hospital Evergreen Park Illinois
Edward Hines Jr VA Hospital Hines Illinois
Carle Physician Group-Mattoon/Charleston Mattoon Illinois
Trinity Medical Center Moline Illinois

+ 129 more sites — see the full list on the official registry below.

More SWOG Cancer Research Network trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03939481 on ClinicalTrials.gov ↗ ← All trials in Mexico