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
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)
Number of Participants With Development of Peripheral Neuropathy — Up to 24 weeks Will be measured as an absolute increase of \>= 8 points over the baseline chemotherapy-induced peripheral neuropathy (CIPN)-20 sensory neuropathy subscale score. Will be collected before or at the 24-week assessment..
Trial sites (169)
Facility
City
Region
Status
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
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.
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