Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21
NCT ID: NCT05452902
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2023-01-19
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
EXCAP Exercise
12 weeks of at-home walking and resistance exercise.
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.
Nutrition Education
12 weeks of implementing eating tips and tracking food.
Interventions
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EXCAP Exercise
12 weeks of at-home walking and resistance exercise.
Nutrition Education
12 weeks of implementing eating tips and tracking food.
Eligibility Criteria
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Inclusion Criteria
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
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.
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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Maryland, Baltimore
OTHER
Responsible Party
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Ian Kleckner, PhD, MPH
Associate Professor
Locations
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University of Maryland Medical System
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Ian Kleckner, PhD, MPH
Role: primary
References
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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.
Other Identifiers
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HP-00100000
Identifier Type: -
Identifier Source: org_study_id