Cancer Activity and Lifestyle Measurement Study

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT03961685
• Lead Sponsor: Ohio State University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-04
• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Cardiac Magnetic Resonance from baseline to study completion, an average of 3 weeks)	Baseline and study completion, an average of 3 weeks	Measurement of Cardiac Functions using Magnetic Resonance Imaging (MRI)
Change in Peripheral Blood Mononuclear Cell Cardiolipin from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	Measurement of a phospholipid in the mitochondrial membrane of white blood cells
Change in Skeletal Muscle 31Phosphorous Magnetic Resonance Spectroscopy (P-MRS) from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	Measurement of energy recovery and fat content of the calf muscle

Secondary Outcome Measures

Name	Time	Method
Change in MRI liver lipid content from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	Measurement of Liver Lipid content using Magnetic Resonance Imaging (MRI)
Change in Breast Cancer Prevention Trial (BCPT) symptoms from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	BCPT symptoms questionnaire measures symptoms related to breast cancer treatment
Change in Fatigue Questionnaire from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	Measures fatigue in breast cancer patients
Change in Linoleic Acid in the blood from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	Linoleic acid levels in the plasma and erythrocytes
Change in Habitual and recent dietary intake from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	Measurement of dietary intake in the past month using Dietary History Questionnaire and recent intake will be measured using 24-hour recall
Change in Physical Activity Questionnaires from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	two questionnaire will be used to measure physical activity and leisure time activity
Change in Short form Health Survey (SF-36) Questionnaire from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	Measures general physical functioning and well-being
Change in Sleep Disturbance Questionnaire from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	Assesses sleep quality and sleep-related impairments
Change in Dual-Energy X-Ray Absorptiometry (DEXA) from baseline to study completion, an average of 3 weeks	Baseline and study completion, an average of 3 weeks	Measures body composition (adipose and muscle mass)

Trial Locations

Locations (1)

The Ohio State University Clinical Research Center (Davis Medical Research Center); 🇺🇸 Columbus, Ohio, United States