May 1, 2019
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May 6, 2019
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May 5, 2022
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March 1, 2019
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February 28, 2025 (Final data collection date for primary outcome measure)
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Development of peripheral neuropathy [ Time Frame: 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 as the taxane-based chemotherapy regimens in this study are expected to be completed within 8 to 18 weeks. The presence of CIPN will be captured at 52 weeks to evaluate the duration of neuropathy which is anticipated to wane after treatment discontinuation.
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Same as current
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- CIPN symptoms [ Time Frame: Up to 52 weeks ]
Patients experiencing a treatment change attributed to CIPN symptoms
- Dose Changes [ Time Frame: Up to 52 weeks ]
Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan)
- Health-related Quality of Life [ Time Frame: Up to 52 weeks ]
Assessed using the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). The PROMIS-29 is a well validated assessment tool that offers both qualitative and quantitative measures of health-related quality of life. The PROMIS-29 includes 29 questions evaluating areas of physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning.
- Visual Analog Toxicity Score [ Time Frame: Up to 52 weeks ]
Assessed using the Visual Analog Toxicity Score. The Visual Analog Toxicity Score is a single question asking the physician to rate how the physician feels the patient's disease and treatment affects their daily life on a scale from 0 (no symptoms and no effect on life) to 10 (severe effects of treatment and patient would rather be dead).
- Patient Reported Symptom [ Time Frame: Up to 52 weeks ]
Assessed using the Patient Reported Symptom Burden Score. The Patient Reported Symptom Score at baseline contains one question to assess how cancer symptoms affect the patient's life (scale 0 [no burden at all] to 10 [a great burden]). At follow-up, the Symptom Burden Score contains five questions: 1) to assess burden of side effects of cancer treatment on life (scale 0 [no burden at all] to 10 [a great burden]), 2) to assess severity of side effects from cancer treatment (scale 0 [no side effects]) to 10 [side effects extremely severe and unbearable]), 3) to assess tolerability of side effects for set time periods (yes/no), 4) to assess level at which treatment would be considered intolerable (scale 0 [side effects not severe at all] to 10 [side effects extremely severe and unbearable]), and 5) to assess the burden of cancer symptoms and treatment symptoms (scale 0 [no burden at all] to 10 [a great burden]).
- Leisure-time Exercise Habits [ Time Frame: Up to 52 weeks ]
Assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ). The GSLTPAQ is a brief 4 item self-administered questionnaire of usual leisure-time exercise habits over a typical 7-day period. The Leisure Score Index (LSI) is calculated based on the first 3 questions. The LSI scores can be used to classify respondents into active (LSI > 24) and insufficiently active (LSI < 23) categories.
- Patient-Reported Outcomes [ Time Frame: Up to 52 weeks ]
Assessed using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE [CTCAE Version 5.0]). PRO-CTCAE assesses 78 adverse events by self-report with 124 items. Each item uses a plain language term for the adverse event, the attribute of interest, and the standard recall period of "the past 7 days".
- National Cancer Institute-Common Terminology Criteria for Adverse Events [ Time Frame: Up to 52 weeks ]
The NCI-CTCAE is a subjective method to evaluate CIPN performed by a healthcare professional. The treating physician will grade the subject's dysesthesia, paresthesia, neuralgia, peripheral sensory neuropathy, and peripheral motor neuropathy on a scale of 0 to 5 depending on the severity. The advantage of the NCI-CTCAE is that the assessment is quick and easy for providers to perform, (8) but it is limited by the subjectivity of interpretation, lack of detail about location, type, and severity of impairment, and narrow scoring range.
- Assess incidence of CIPN [ Time Frame: Up to 52 weeks ]
Assessed using European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 (CIPN-20). The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.
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- Patients experiencing a treatment change attributed to CIPN symptoms [ Time Frame: Up to 52 weeks ]
- Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan) [ Time Frame: Up to 52 weeks ]
- Health-related Quality of Life [ Time Frame: Up to 52 weeks ]
Assessed using the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). The PROMIS-29 is a well validated assessment tool that offers both qualitative and quantitative measures of health-related quality of life. The PROMIS-29 includes 29 questions evaluating areas of physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning.
- Visual Analog Toxicity Score [ Time Frame: Up to 52 weeks ]
Assessed using the Visual Analog Toxicity Score. The Visual Analog Toxicity Score is a single question asking the physician to rate how the physician feels the patient's disease and treatment affects their daily life on a scale from 0 (no symptoms and no effect on life) to 10 (severe effects of treatment and patient would rather be dead).
- Patient Reported Symptom [ Time Frame: Up to 52 weeks ]
Assessed using the Patient Reported Symptom Burden Score. The Patient Reported Symptom Score at baseline contains one question to assess how cancer symptoms affect the patient's life (scale 0 [no burden at all] to 10 [a great burden]). At follow-up, the Symptom Burden Score contains five questions: 1) to assess burden of side effects of cancer treatment on life (scale 0 [no burden at all] to 10 [a great burden]), 2) to assess severity of side effects from cancer treatment (scale 0 [no side effects]) to 10 [side effects extremely severe and unbearable]), 3) to assess tolerability of side effects for set time periods (yes/no), 4) to assess level at which treatment would be considered intolerable (scale 0 [side effects not severe at all] to 10 [side effects extremely severe and unbearable]), and 5) to assess the burden of cancer symptoms and treatment symptoms (scale 0 [no burden at all] to 10 [a great burden]).
- Leisure-time Exercise Habits [ Time Frame: Up to 52 weeks ]
Assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ). The GSLTPAQ is a brief 4 item self-administered questionnaire of usual leisure-time exercise habits over a typical 7-day period. The Leisure Score Index (LSI) is calculated based on the first 3 questions. The LSI scores can be used to classify respondents into active (LSI > 24) and insufficiently active (LSI < 23) categories.
- Patient-Reported Outcomes [ Time Frame: Up to 52 weeks ]
Assessed using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE [CTCAE Version 5.0]). PRO-CTCAE assesses 78 adverse events by self-report with 124 items. Each item uses a plain language term for the adverse event, the attribute of interest, and the standard recall period of "the past 7 days".
- National Cancer Institute-Common Terminology Criteria for Adverse Events [ Time Frame: Up to 52 weeks ]
The NCI-CTCAE is a subjective method to evaluate CIPN performed by a healthcare professional. The treating physician will grade the subject's dysesthesia, paresthesia, neuralgia, peripheral sensory neuropathy, and peripheral motor neuropathy on a scale of 0 to 5 depending on the severity. The advantage of the NCI-CTCAE is that the assessment is quick and easy for providers to perform, (8) but it is limited by the subjectivity of interpretation, lack of detail about location, type, and severity of impairment, and narrow scoring range.
- Assess incidence of CIPN [ Time Frame: Up to 52 weeks ]
Assessed using European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 (CIPN-20). The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.
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Not Provided
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Performance status [ Time Frame: Up to 52 weeks ] Assessed using the Zubrod performance status scale. This scale is used to evaluate the patient's performance status is an attempt to quantify cancer patients' general well-being and activities of daily life.
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Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
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A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
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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.
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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.
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Observational
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Observational Model: Cohort Time Perspective: Prospective
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Not Provided
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Not Provided
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Non-Probability Sample
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Participants with stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer
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- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB 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
- 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
- Lung Non-Small Cell Carcinoma
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB 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
- 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
- Stage I Lung Cancer AJCC v8
- Stage I Ovarian Cancer AJCC v8
- Stage IA Ovarian 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 IB Ovarian Cancer AJCC v8
- Stage IC Ovarian Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage II Ovarian Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Stage IIA Ovarian Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Stage IIB Ovarian Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IIIA1 Ovarian Cancer AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
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- 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
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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.
Interventions:
- Drug: Chemotherapy
- Other: Functional Assessment
- Other: Questionnaire Administration
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Not Provided
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Active, not recruiting
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1336
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1050
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February 28, 2026
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February 28, 2025 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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Chile, Colombia, Mexico, United States
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NCT03939481
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S1714 NCI-2018-01568 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) S1714 ( Other Identifier: SWOG ) SWOG-S1714 ( Other Identifier: DCP ) S1714 ( Other Identifier: CTEP ) UG1CA189974 ( U.S. NIH Grant/Contract )
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Yes
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Not Provided
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Not Provided
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Southwest Oncology Group
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Same as current
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Southwest Oncology Group
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Same as current
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National Cancer Institute (NCI)
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Principal Investigator: |
Meghna S Trivedi |
Southwest Oncology Group |
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Southwest Oncology Group
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May 2022
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