Exercise and Nutrition Interventions During Chemotherapy K07

Neuropathy;Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858153
• Other study ID #: STUDY00003387
• Secondary ID: K07CA221931
• Status: Recruiting
• Phase: Phase 2
• Start date: April 15, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: August 2023
• Source: University of Rochester
• 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 taxane chemotherapy, often used to treat breast cancer. 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: 80
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria (subjects must…)

1. Be female

2. Have breast cancer

3. Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)

4. Have at least six months life expectancy according to the patient's oncologist or designee

5. Be able to read English

6. Be at least 18 years old (no upper limit on age)

7. Provide written informed consent

Exclusion criteria (subjects must not…)

1. Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)

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.

Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects)

1. Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)

Related Conditions & MeSH terms

• Neuropathy;Peripheral
• 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	Baltimore	Maryland
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	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	Musculoskeletal function	Leg strength via isokinetic 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
Other	Neuropsychological function	Brain connectivity via functional magnetic resonance imaging	Time point 2 (approx. 6 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
Primary	Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)	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	Sensory loss	Finger tactile sensitivity	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
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	Patient-reported sensory symptoms of CIPN	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 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline