Clinical trial NCT05452902: Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21
Official title: The Effects of Exercise and Nutrition Interventions on Platinum Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry (R21)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Chemotherapy
Brain
Exercise
Nutrition
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: CIPN-20 sensory subscale
timeFrame: Time point 2 (approximately 6 weeks), controlling for baseline value
Secondary outcomes:
measure: CIPN-20 sensory subscale
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
measure: Sensory, motor, and autonomic symptoms of CIPN
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
measure: Sensory loss
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
measure: Cold-induced pain
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
measure: Numbness and tingling
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Other outcomes:
measure: Neuropsychological function
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
measure: Immunological function
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
measure: Musculoskeletal function
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
measure: Cardiovascular function
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
Study officials:
References:
citation: 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.