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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)
2 other identifiers
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedStudy Start
First participant enrolled
January 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2025
CompletedJanuary 26, 2026
January 1, 2026
2.7 years
July 6, 2022
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
CIPN-20 sensory subscale
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 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 point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Cold-induced pain
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Numbness and tingling
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Other Outcomes (4)
Neuropsychological function
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Immunological function
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Musculoskeletal function
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
- +1 more other outcomes
Study Arms (2)
EXCAP Exercise
EXPERIMENTALExercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.
Nutrition Education
ACTIVE COMPARATORNutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.
Interventions
12 weeks of implementing eating tips and tracking food.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of cancer
- 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
- Be able to read English
- Be ≥18 years
You may not qualify if:
- 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.
- 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.
- Have planned surgery or radiation treatment in the 12 weeks after baseline.
- Have current or prior cancer in the spine, brainstem, or brain (to allow standard brain MRI analysis)
- Have contraindications for MRI scanning (pacemaker, ferrous metal implants, pregnancy, etc. note that most port-a-caths are safe for MRI scanning)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Maryland, Baltimorelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Maryland Medical System
Baltimore, Maryland, 21201, United States
Related Publications (1)
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.
PMID: 15911236BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 6, 2022
First Posted
July 11, 2022
Study Start
January 19, 2023
Primary Completion
September 25, 2025
Study Completion
September 25, 2025
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- See above plan
- 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
* 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.