Cancer Activity and Lifestyle Measurement Study

NCT ID: NCT03961685

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2025-12-31

Brief Summary

The CALM Study is an observational study to investigate the associations of linoleic acid levels in the blood, diet, activity, and lifestyle factors with measures of muscle strength, muscle function and overall outcomes for postmenopausal breast cancer patients treated with anthracycline chemotherapy.

Detailed Description

The CALM Study is a prospective study to determine the effects of adjuvant chemotherapy on cardiolipin profiles in relationship to cardiac and skeletal muscle function in breast cancer patients before and after 1 cycle of anthracycline therapy. Patients will undergo blood sampling and imaging of the heart and skeletal muscle at two Clinical Visits. The two visits, Baseline and study completion (Post-1 cycle anthracycline) will occur approximately ~4 weeks apart.

The driving hypothesis is that anthracycline reduces linoleic acid-rich cardiolipin with associated decline of cardiac and skeletal muscle measures. By coupling cardiac and skeletal muscle changes with cardiolipin markers reflective of dietary linoleic acid, this work will advance inexpensive and highly accessible therapies to preserve functional capacity and diminish adverse outcomes in cancer patients. Breast cancer patients (stages I-III) receiving anthracycline will be prospectively evaluated to achieve the following aims:

Aim 1: Measure the baseline relationships between cardiolipin status and magnetic resonance-based measures of cardiac and skeletal muscle physiology in breast cancer patients. Hypothesis 1a: Higher cardiolipin is related to better cardiac structure and function. Hypothesis 1b: Higher cardiolipin is associated with higher skeletal muscle mass and mitochondrial capacity in women with breast cancer prior to starting anthracycline therapy. Hypothesis 1c: Dietary linoleic acid modifies the relationships between cardiolipin and cardiac or skeletal muscle measures.

Aim 2: Assess chemotherapy-induced changes in cardiolipin composition, cardiac and skeletal muscle physiology. Hypothesis 2a: Change in skeletal muscle function and cardiac function together better predict worse functional capacity after completion of a course of anthracycline therapy for breast cancer compared to change of either skeletal or cardiac function alone. Hypothesis 2b: Cardiolipin levels decrease significantly from baseline in women who have completed one cycle of anthracycline therapy for breast cancer. Hypothesis 2c: Dietary linoleic acid modifies the effects of anthracycline on cardiolipin and cardiac or skeletal muscle physiology.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of stage I-II breast cancer, adjuvant or neoadjuvant anthracycline therapy

Exclusion Criteria

• current smoker, under medical supervision for any other type of cancer, prior history of malignancies, infection requiring antibiotics in the last 3 months, diagnosis of hear disease or previous heart attach, stroke, or heart surgery, pacemaker or defibrillator, cardiac edema, autoimmune or inflammatory disease, current use of hormone replacement therapy, liver diseases, kidney diseases or failure, digestive diseases, pulmonary diseases or edema, diabetes, severe claustrophobia and/or metal implants preventing MRI measurement, orthopedic diagnoses prevent mobility, mitochondrial diseases, any other condition that would impede or be contraindicated for study assessments

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Martha Belury

Carol S. Kennedy Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University Clinical Research Center (Davis Medical Research Center)

Columbus, Ohio, United States

Countries

United States

References

Marris KE, Cole RM, Addison D, Ruz P, Sparagna G, Ni A, Belury MA. The Relationship Between Blood Lipidomics and Cardiotoxic Injury Following Acute Exposure to Anthracycline Chemotherapy in Women With Breast Cancer: A Feasibility Study. Curr Dev Nutr. 2025 Sep 4;9(10):107552. doi: 10.1016/j.cdnut.2025.107552. eCollection 2025 Oct.

Reference Type: DERIVED

PMID: 41069420 (View on PubMed)

Other Identifiers

2017C0165

Identifier Type: -

Identifier Source: org_study_id