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Exercise and Nutrition Interventions During Chemotherapy K07

NCT ID: NCT03858153

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2025-08-27

Brief Summary

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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

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Conditions

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Neuropathy;Peripheral

Keywords

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chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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).

Study Groups

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Exercise

Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.

Group Type EXPERIMENTAL

EXCAP Exercise

Intervention Type BEHAVIORAL

12 weeks of at-home walking and resistance exercise.

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.

Group Type ACTIVE_COMPARATOR

Nutrition Education

Intervention Type BEHAVIORAL

12 weeks of implementing eating tips and tracking food.

Interventions

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EXCAP Exercise

12 weeks of at-home walking and resistance exercise.

Intervention Type BEHAVIORAL

Nutrition Education

12 weeks of implementing eating tips and tracking food.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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.


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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Po-Ju Lin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15911236 (View on PubMed)

Other Identifiers

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K07CA221931

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003387

Identifier Type: -

Identifier Source: org_study_id