Cancer Activity and Lifestyle Measurement Study

Breast Cancer Clinical Trial

— CALM  

Official title:

The CALM Study: Cancer Activity and Lifestyle Measurement Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03961685
• Other study ID #: 2017C0165
• Status: Active, not recruiting
• Start date: January 4, 2019
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	The Ohio State University Clinical Research Center (Davis Medical Research Center)	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Baseline and study completion, an average of 3 weeks
Other	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	Baseline and study completion, an average of 3 weeks
Primary	Change in Cardiac Magnetic Resonance from baseline to study completion, an average of 3 weeks)	Measurement of Cardiac Functions using Magnetic Resonance Imaging (MRI)	Baseline and study completion, an average of 3 weeks
Primary	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	Baseline and study completion, an average of 3 weeks
Primary	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	Baseline and study completion, an average of 3 weeks
Secondary	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	Baseline and study completion, an average of 3 weeks
Secondary	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	Baseline and study completion, an average of 3 weeks
Secondary	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	Baseline and study completion, an average of 3 weeks
Secondary	Change in Fatigue Questionnaire from baseline to study completion, an average of 3 weeks	Measures fatigue in breast cancer patients	Baseline and study completion, an average of 3 weeks
Secondary	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	Baseline and study completion, an average of 3 weeks
Secondary	Change in Sleep Disturbance Questionnaire from baseline to study completion, an average of 3 weeks	Assesses sleep quality and sleep-related impairments	Baseline and study completion, an average of 3 weeks
Secondary	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	Baseline and study completion, an average of 3 weeks
Secondary	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)	Baseline and study completion, an average of 3 weeks
Secondary	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)	Baseline and study completion, an average of 3 weeks