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COMPLETED Phase 2

Exercise and Nutrition Interventions During Chemotherapy K07

NCT03858153 · View on ClinicalTrials.gov ↗

Study Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.

Conditions Studied

Interventions

  • BEHAVIORAL Nutrition Education
  • BEHAVIORAL EXCAP Exercise

Study Locations (2)

Maryland

  • University of Maryland — Baltimore

New York

  • University of Rochester Medical Center — Rochester

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2019-04-15
Est. Completion 2025-08-27
Phase Phase 2

Sponsor

University of Rochester

437 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03858153

The ClinicalTrials.gov registry entry for NCT03858153 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 437 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Neuropathy;Peripheral appearing as the primary indexed condition, and to 2 interventions — of which Nutrition Education is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03858153 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Maryland, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03858153 about?

NCT03858153 is a clinical study titled "Exercise and Nutrition Interventions During Chemotherapy K07". Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exerc...

What is the current status of trial NCT03858153?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2019-04-15. Estimated completion is 2025-08-27.

What conditions does trial NCT03858153 study?

This clinical trial studies the following conditions: Neuropathy;Peripheral. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03858153?

The interventions under investigation include: Nutrition Education (BEHAVIORAL), EXCAP Exercise (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03858153?

This trial is sponsored by University of Rochester, which has 437 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03858153 being conducted?

This trial has 2 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial