Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21

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: Terminated
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Behavioral: EXCAP Exercise; Behavioral: Nutrition Education

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
CIPN-20 sensory subscale	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

Outcome Measure	Measure Description	Time Frame
CIPN-20 sensory subscale	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	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	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	Finger cold sensitivity using thermode	Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Numbness and tingling	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

Outcome Measure	Measure Description	Time Frame
Neuropsychological function	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	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	Strength via handgrip dynamometer test	Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Cardiovascular function	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

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): September 25, 2025
• Study Completion (Actual): September 25, 2025

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Nutrition; Brain; Chemotherapy
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID 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