Exercise and Nutrition Interventions During Chemotherapy K07

• Sponsor: University of Rochester (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03858153
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 80
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 61.6
• Patients Per Site: 40
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathy;Peripheral	Behavioral: EXCAP Exercise; Behavioral: Nutrition Education	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Assessor and investigator will be masked of Arms to the extent possible (i.e., for some outcomes e.g., biomarkers but not others e.g. symptom tests).
• Primary Purpose: Supportive Care
• Official Title: The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
• Actual Study Start Date: Apr 15, 2019
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.	Behavioral: EXCAP Exercise; 12 weeks of at-home walking and resistance exercise.
Active Comparator: 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.	Behavioral: Nutrition Education; 12 weeks of implementing eating tips and tracking food.

Outcome Measures

Primary Outcome Measures

1. Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN) [Time point 2 (approximately 6 weeks), controlling for baseline value]

   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).

Secondary Outcome Measures

1. Sensory loss [Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline]

   Finger tactile sensitivity

2. Numbness and tingling [Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline]

   Patient-reported severity of numbness/tingling (0-10). A larger value reflects more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).

3. 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]

   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).

4. Patient-reported sensory symptoms of CIPN [Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline]

   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).

Other Outcome Measures

1. Musculoskeletal function [Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline]

   Leg strength via isokinetic dynamometer test

2. Cardiovascular function [Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline]

   Distance walked in six-minute walk test

3. Neuropsychological function [Time point 2 (approx. 6 weeks), controlling for baseline]

   Brain connectivity via functional magnetic resonance imaging

4. Immunological function [Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline]

   Inflammatory cytokine concentration via ELISA (IL-6, IL-10, etc.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland	Baltimore	Maryland	United States	21201
2	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• National Cancer Institute (NCI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lantéri-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. Epub 2005 Apr 14.

• Responsible Party: Po-Ju Lin, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03858153
• Other Study ID Numbers: STUDY00003387
• First Posted: Feb 28, 2019
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Po-Ju Lin, Assistant Professor, University of Rochester: chemotherapy
• Additional relevant MeSH terms: Peripheral Nervous System Diseases

Study Results

No Results Posted as of Jul 5, 2022