Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21

January 22, 2026 updated by: Ian Kleckner, PhD, MPH, University of Maryland, Baltimore

The Effects of Exercise and Nutrition Interventions on Platinum Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry (R21)

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria (subjects must…)

  1. Have a diagnosis of cancer
  2. Be scheduled to receive platinum chemotherapy (specifically oxaliplatin or cisplatin) without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide). Patients may be enrolled before their first (preferred), second, or third infusion of neurotoxic chemotherapy
  3. Be able to read English
  4. Be ≥18 years

Exclusion criteria (subjects must not…)

  1. Be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. To be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat.
  2. Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.
  3. Have planned surgery or radiation treatment in the 12 weeks after baseline.

Additional exclusion criteria only for patients completing MRI (approximately 40 of 60 enrolled subjects; subjects must not…)

  1. Have current or prior cancer in the spine, brainstem, or brain (to allow standard brain MRI analysis)
  2. Have contraindications for MRI scanning (pacemaker, ferrous metal implants, pregnancy, etc. note that most port-a-caths are safe for MRI scanning)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EXCAP Exercise
Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.
Behavioral: EXCAP Exercise
12 weeks of at-home walking and resistance exercise.
Active Comparator: Nutrition Education
Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.
Behavioral: Nutrition Education
12 weeks of implementing eating tips and tracking food.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CIPN-20 sensory subscale
Time Frame: Time point 2 (approximately 6 weeks), controlling for baseline value
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Time point 2 (approximately 6 weeks), controlling for baseline value

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CIPN-20 sensory subscale
Time Frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
Sensory, motor, and autonomic symptoms of CIPN
Time Frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
CIPN-20 total score (Postma et al 2005). The score includes 20 questions, each rated 1-4, and the score ranges from 20-80 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
Sensory loss
Time Frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Finger and toe tactile sensitivity using monofilaments
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Cold-induced pain
Time Frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Finger cold sensitivity using thermode
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Numbness and tingling
Time Frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Patient-reported severity of numbness/tingling (0-10). A larger value reflects more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neuropsychological function
Time Frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Brain connectivity via functional magnetic resonance imaging
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Immunological function
Time Frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Inflammatory cytokine concentration via ELISA (IL-6, IL-10, etc.)
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Musculoskeletal function
Time Frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Strength via handgrip dynamometer test
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Cardiovascular function
Time Frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Distance walked in six-minute walk test
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, Baltimore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HP-00100000
  • R21CA259422 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

  • First, we will conduct our primary analyses (Aims 1-4) on the data collected and publish our results with a group of researchers determined by the PI: Dr. Kleckner. Our team has already worked together to develop our study design, analysis plan, dissemination plan, etc. and we want to be the ones to publish our findings.
  • Second, after the primary analyses (Aims 1-4) have been published (or at the discretion of the PI), we welcome collaboration with others who want to analyze our data as long as we are offered an opportunity for co-authorship and collaboration (not simply passing the data off to another research group). We may or may not accept the invitation for co-authorship depending on the timing and nature of the research.
  • Third, if there are questions about the validity of our published findings and other research groups want to perform an independent analysis that they feel would be compromised by our co-authorship or collaboration, then we are open to that possibility.

IPD Sharing Time Frame

See above plan

IPD Sharing Access Criteria

Researchers analyzing our data must adhere to the following agreement (or similar), which will be presented in writing and signed and dated:

  • They will not transfer the data to another party (i.e., all data requests come to the study PI, Dr. Kleckner)
  • They will maintain the security and privacy of the data (secure data servers, password-protected computers, secure data transfer methods, etc.).
  • They will acknowledge our funding sources that supported collection of the data (including this R21)
  • They will offer collaboration and co-authorship unless that would be deemed inappropriate for ethical reasons (e.g., conducting an independent analysis)
  • They will notify the study PI, Dr. Kleckner of dissemination (abstracts, manuscripts, etc.)
  • They will provide regular updates to Dr. Kleckner on progress analyzing the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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