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Recruiting NCT05704842

Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy

Conditions: Breast Cancer

Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: Virtua Health, Inc.

Location: United States

Summary

Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.

Eligibility Criteria

Inclusion Criteria:Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy.Age > 18 yearsECOG performance score < 3English-speakingwith sufficient vision/hearing or family supportCoronary artery disease, if cleared by cardiologistSubject must have smart phone, computer or tablet.Willingness to be randomizedExclusion Criteria:Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions).Patients with overt evidence of a psychiatric disorder.Coronary artery disease, not cleared by cardiologist.Contraindication to exercise.Chronic fatigue syndrome.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05704842). StuddyBuddy aggregates publicly available trial information.