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

• Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Southwest Oncology Group

Tracking Information

• First Submitted Date: May 1, 2019
• First Posted Date: May 6, 2019
• Last Update Posted Date: August 8, 2019
• Actual Study Start Date: March 1, 2019
• Estimated Primary Completion Date: August 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 3, 2019)

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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03939481 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 3, 2019)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: May 3, 2019)

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.

Descriptive Information

• Brief Title: Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
• Official Title: A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
• Brief 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.

Detailed 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Participants with stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer

Condition

• 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

Intervention

• 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

Study Groups/Cohorts

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 3, 2019): 1050
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2025
• Estimated Primary Completion Date: August 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03939481
• Other Study ID Numbers: 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 )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Southwest Oncology Group
• Study Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Meghna S Trivedi; Southwest Oncology Group

• PRS Account: Southwest Oncology Group
• Verification Date: August 2019