Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452902
• Other study ID #: HP-00100000
• Secondary ID: R21CA259422
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: University of Maryland, Baltimore
• Contact: Ian Kleckner, PhD, MPH
• Phone: 410-706-5981
• Email: ian.kleckner[@]umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• EXCAP Exercise
12 weeks of at-home walking and resistance exercise.
• Nutrition Education
12 weeks of implementing eating tips and tracking food.

Locations

Country	Name	City	State
United States	University of Maryland Medical System	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Musculoskeletal function	Strength via handgrip dynamometer test	Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Cold-induced pain	Finger cold sensitivity using thermode	Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Secondary	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