An observational study in Breast Cancer, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to female participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Ohio State University · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 14 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women ≥25 and \< 70 years with stage I-III breast cancer who have adjuvant or neoadjuvant planned AC treatment will be screened for enrollment.
Exclusion Criteria:
Change in Cardiac Magnetic Resonance from baseline to study completion, an average of 3 weeks)
Measurement of Cardiac Functions using Magnetic Resonance Imaging (MRI)
Time frame: Baseline and study completion, an average of 3 weeks
Change in Skeletal Muscle 31Phosphorous Magnetic Resonance Spectroscopy (P-MRS) from baseline to study completion, an average of 3 weeks
Measurement of energy recovery and fat content of the calf muscle
Time frame: Baseline and study completion, an average of 3 weeks
Change in Peripheral Blood Mononuclear Cell Cardiolipin from baseline to study completion, an average of 3 weeks
Measurement of a phospholipid in the mitochondrial membrane of white blood cells
Time frame: Baseline and study completion, an average of 3 weeks
Change in Habitual and recent dietary intake from baseline to 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
Time frame: Baseline and study completion, an average of 3 weeks
Change in Physical Activity Questionnaires from baseline to study completion, an average of 3 weeks
two questionnaire will be used to measure physical activity and leisure time activity
Time frame: Baseline and study completion, an average of 3 weeks
Change in Breast Cancer Prevention Trial (BCPT) symptoms from baseline to study completion, an average of 3 weeks
BCPT symptoms questionnaire measures symptoms related to breast cancer treatment
Time frame: Baseline and study completion, an average of 3 weeks
Change in Fatigue Questionnaire from baseline to study completion, an average of 3 weeks
Measures fatigue in breast cancer patients
Time frame: Baseline and study completion, an average of 3 weeks
Change in Short form Health Survey (SF-36) Questionnaire from baseline to study completion, an average of 3 weeks
Measures general physical functioning and well-being
Time frame: Baseline and study completion, an average of 3 weeks
Change in Sleep Disturbance Questionnaire from baseline to study completion, an average of 3 weeks
Assesses sleep quality and sleep-related impairments
Time frame: Baseline and study completion, an average of 3 weeks
Change in Linoleic Acid in the blood from baseline to study completion, an average of 3 weeks
Linoleic acid levels in the plasma and erythrocytes
Time frame: Baseline and study completion, an average of 3 weeks
Change in Dual-Energy X-Ray Absorptiometry (DEXA) from baseline to study completion, an average of 3 weeks
Measures body composition (adipose and muscle mass)
Time frame: Baseline and study completion, an average of 3 weeks
Change in MRI liver lipid content from baseline to study completion, an average of 3 weeks
Measurement of Liver Lipid content using Magnetic Resonance Imaging (MRI)
Time frame: Baseline and study completion, an average of 3 weeks
Change in Body Mass Index (BMI) from baseline to study completion, an average of 3 weeks
Indirect measure of body composition using weight and height
Time frame: Baseline and study completion, an average of 3 weeks
Change in Omega-3 Intake Checklist from baseline to study completion, an average of 3 weeks
Measure the amount of omega-3 fatty acid consumed in the diet
Time frame: Baseline and study completion, an average of 3 weeks
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Ohio State University