Clinical trial · Observational
Cancer Activity and Lifestyle Measurement Study
The CALM Study: Cancer Activity and Lifestyle Measurement Study
NCT03961685CI-TRIAL-00108876CALMactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Change in Cardiac Magnetic Resonance from baseline to study completion, an average of 3 weeks)
- timeFrame
- Baseline and study completion, an average of 3 weeks
- description
- Measurement of Cardiac Functions using Magnetic Resonance Imaging (MRI)
- measure
- Change in Skeletal Muscle 31Phosphorous Magnetic Resonance Spectroscopy (P-MRS) from baseline to study completion, an average of 3 weeks
- timeFrame
- Baseline and study completion, an average of 3 weeks
- description
- Measurement of energy recovery and fat content of the calf muscle
- measure
- Change in Peripheral Blood Mononuclear Cell Cardiolipin from baseline to study completion, an average of 3 weeks
- timeFrame
- Baseline and study completion, an average of 3 weeks
- description
- Measurement of a phospholipid in the mitochondrial membrane of white blood cells
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMarris 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. PMID 41069420