Exercise and Nutrition Interventions During Chemotherapy K07

Phase 2

Recruiting

• Conditions: Neuropathy;Peripheral

• Registration Number: NCT03858153
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Study Start: 2019-04-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Sensory loss	Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline	Finger tactile sensitivity
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).
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).
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).

Trial Locations

Locations (2)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States