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
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
| Condition | Stage III Ovarian Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8, Stage IIIB Ovarian Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Lung Non-Small Cell Carcinoma, Stage I Ovarian Cancer AJCC v8, Stage IA Ovarian Cancer AJCC v8, Stage IB Ovarian Cancer AJCC v8, Stage IC Ovarian Cancer AJCC v8, Stage II Ovarian Cancer AJCC v8, Stage IIA Ovarian Cancer AJCC v8, Stage IIB Ovarian Cancer AJCC v8, Stage IIIA1 Ovarian Cancer AJCC v8, Stage IIIA2 Ovarian Cancer AJCC v8, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma |
|---|---|
| Treatment | questionnaire administration, Chemotherapy, Functional Assessment |
| Clinical Study Identifier | NCT03939481 |
| Sponsor | Southwest Oncology Group |
| Last Modified on | 6 May 2021 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer