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Cancer Activity and Lifestyle Measurement Study (CALM)

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ClinicalTrials.gov Identifier: NCT03961685
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Martha Belury, 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.

Condition or disease
Breast Cancer

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.


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Study Type : Observational
Estimated Enrollment : 54 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The CALM Study: Cancer Activity and Lifestyle Measurement Study
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in Cardiac Magnetic Resonance from baseline to study completion, an average of 3 weeks) [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Measurement of Cardiac Functions using Magnetic Resonance Imaging (MRI)

  2. Change in Skeletal Muscle 31Phosphorous Magnetic Resonance Spectroscopy (P-MRS) from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Measurement of energy recovery and fat content of the calf muscle

  3. Change in Peripheral Blood Mononuclear Cell Cardiolipin from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Measurement of a phospholipid in the mitochondrial membrane of white blood cells


Secondary Outcome Measures :
  1. Change in Habitual and recent dietary intake from baseline to study completion, an average of 3 weeks [ Time Frame: 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

  2. Change in Physical Activity Questionnaires from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    two questionnaire will be used to measure physical activity and leisure time activity

  3. Change in Breast Cancer Prevention Trial (BCPT) symptoms from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    BCPT symptoms questionnaire measures symptoms related to breast cancer treatment

  4. Change in Fatigue Questionnaire from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Measures fatigue in breast cancer patients

  5. Change in Short form Health Survey (SF-36) Questionnaire from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Measures general physical functioning and well-being

  6. Change in Sleep Disturbance Questionnaire from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Assesses sleep quality and sleep-related impairments

  7. Change in Linoleic Acid in the blood from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Linoleic acid levels in the plasma and erythrocytes

  8. Change in Dual-Energy X-Ray Absorptiometry (DEXA) from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Measures body composition (adipose and muscle mass)

  9. Change in MRI liver lipid content from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Measurement of Liver Lipid content using Magnetic Resonance Imaging (MRI)


Other Outcome Measures:
  1. Change in Body Mass Index (BMI) from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Indirect measure of body composition using weight and height

  2. Change in Omega-3 Intake Checklist from baseline to study completion, an average of 3 weeks [ Time Frame: Baseline and study completion, an average of 3 weeks ]
    Measure the amount of omega-3 fatty acid consumed in the diet



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women ≥25 and < 70 years with stage I-III breast cancer who have adjuvant or neoadjuvant planned AC treatment will be screened for enrollment.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961685


Contacts
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Contact: Rachel Cole, MS 614-247-8235 cole.311@osu.edu
Contact: Martha Belury, PhD 614-292-1680 belury.1@osu.edu

Locations
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United States, Ohio
The Ohio State University Clinical Research Center (Davis Medical Research Center) Recruiting
Columbus, Ohio, United States, 43210
Contact: Nurses Station    614-293-8750      
Principal Investigator: Martha A Belury, PhD, RD         
Sponsors and Collaborators
Ohio State University

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Responsible Party: Martha Belury, Carol S. Kennedy Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03961685     History of Changes
Other Study ID Numbers: 2017C0165
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No