Exercise and Nutrition Interventions During Chemotherapy K07

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuropathy;Peripheral
• Intervention / Treatment: Behavioral: EXCAP Exercise; Behavioral: Nutrition Education

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ian Kleckner, PhD, MPH; Phone Number: 410-706-5981; Email: ian.kleckner@umaryland.edu
• Study Contact Backup: Name: Po-Ju Lin, PhD, RD, MPH; Phone Number: 585-276-6001; Email: po-ju_lin@URMC.Rochester.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Contact: Ian Kleckner, PhD, MPH; Phone Number: 410-706-5981; Email: ian.kleckner@umaryland.edu
      • Contact: Amelia Wagenknecht, BS; Phone Number: 410-706-6298; Email: awagenknecht@umaryland.edu
  • New York
    • Rochester, New York, United States, 14642
      • Active, not recruiting
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Sensory loss	Finger tactile sensitivity	Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Musculoskeletal function	Leg strength via isokinetic dynamometer test	Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Neuropsychological function	Brain connectivity via functional magnetic resonance imaging	Time point 2 (approx. 6 weeks), controlling for baseline

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: chemotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: STUDY00003387; K07CA221931 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Interested researchers may contact the study PI with requests for collaboration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No