Exercise and Nutrition Interventions During Chemotherapy K07

NCT03858153 | Completed Phase 2 DMC

• 2 other identifiers: STUDY00003387K07CA221931
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuropathy;Peripheral

Keywords

chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensory loss

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

• Numbness and tingling

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

• 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

• Patient-reported sensory symptoms of CIPN

  Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline

Other Outcomes (4)

• Musculoskeletal function

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

• Cardiovascular function

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

• Neuropsychological function

  Time point 2 (approx. 6 weeks), controlling for baseline

Study Arms (2)

Exercise

EXPERIMENTAL

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

Nutrition Education

ACTIVE COMPARATOR

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

Interventions

EXCAP Exercise BEHAVIORAL

12 weeks of at-home walking and resistance exercise.

Exercise

Nutrition Education BEHAVIORAL

12 weeks of implementing eating tips and tracking food.

Nutrition Education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be female
• Have breast cancer
• Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
• Have at least six months life expectancy according to the patient's oncologist or designee
• Be able to read English
• Be at least 18 years old (no upper limit on age)
• Provide written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related 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.

  PMID: 15911236 BACKGROUND

MeSH Terms

Conditions

Neuritis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 28, 2019
• Study Start: April 15, 2019
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)