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

Active, not recruiting

• Conditions: Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8
• Interventions: Drug: Chemotherapy; Other: Functional Assessment; Other: Questionnaire Administration

• Registration Number: NCT03939481
• Lead Sponsor: SWOG Cancer Research Network

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 Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Study Start: 2019-05-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-09-15
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1336

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (non-study chemo, questionnaire, assessments)	Chemotherapy	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.
Observational (non-study chemo, questionnaire, assessments)	Functional Assessment	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.
Observational (non-study chemo, questionnaire, assessments)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
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 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.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Toxicity Score	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).
CIPN symptoms	Up to 52 weeks	Patients experiencing a treatment change attributed to CIPN symptoms
Leisure-time Exercise Habits	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	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".
Dose Changes	Up to 52 weeks	Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan)
Health-related Quality of Life	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.
Patient Reported Symptom	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 \[a great burden\]).
National Cancer Institute-Common Terminology Criteria for Adverse Events	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	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.

Trial Locations

Locations (168)

Kaiser Permanente-Deer Valley Medical Center; 🇺🇸 Antioch, California, United States

Kaiser Permanente Dublin; 🇺🇸 Dublin, California, United States

Kaiser Permanente-Fremont; 🇺🇸 Fremont, California, United States

Kaiser Permanente-Fresno; 🇺🇸 Fresno, California, United States

Kaiser Permanente-Oakland; 🇺🇸 Oakland, California, United States

Desert Regional Medical Center; 🇺🇸 Palm Springs, California, United States

Kaiser Permanente-San Francisco; 🇺🇸 San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose; 🇺🇸 San Jose, California, United States

Kaiser Permanente San Leandro; 🇺🇸 San Leandro, California, United States

Kaiser San Rafael-Gallinas; 🇺🇸 San Rafael, California, United States

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