Breast Cancer

The Ohio State University Clinical Research Center (Davis Medical Research Center)

Cancer Activity and Lifestyle Measurement Study

The CALM Study: Cancer Activity and Lifestyle Measurement Study

Measurement of Cardiac Functions using Magnetic Resonance Imaging (MRI)

Measurement of energy recovery and fat content of the calf muscle

Measurement of a phospholipid in the mitochondrial membrane of white blood cells

Measurement of dietary intake in the past month using Dietary History Questionnaire and recent intake will be measured using 24-hour recall

two questionnaire will be used to measure physical activity and leisure time activity

BCPT symptoms questionnaire measures symptoms related to breast cancer treatment

Measures fatigue in breast cancer patients

Measures general physical functioning and well-being

Assesses sleep quality and sleep-related impairments

Linoleic acid levels in the plasma and erythrocytes

Measures body composition (adipose and muscle mass)

Measurement of Liver Lipid content using Magnetic Resonance Imaging (MRI)

Indirect measure of body composition using weight and height

Measure the amount of omega-3 fatty acid consumed in the diet

Martha Belury

Carol S. Kennedy Professor

Ohio State University

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult colon cancer patients who experienced a CIPN after adjuvant oxaliplatin-containing chemotherapy.

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult breast cancer patients who experienced a CIPN after adjuvant paclitaxel regimen.

CIPN in Adjuvant Colon Cancer Patients

CIPN in Adjuvant Breast Cancer Patients

Daily dosing of dietary supplement OnLife

OnLife

Praxis für interdisziplinäre Onkologie & Hämatologie

Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy

An Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving Chemotherapy-induced peripherAl NeurOpathy in Patients With Colon or Breast Cancer After End of Adjuvant Therapy

Incidence of grade 0/1/2/3/4 peripheral sensory and/ or motor neuropathy according to CTCAE v4.03 after end of adjuvant oxaliplatin-containing regimen (colon cancer) or adjuvant paclitaxel regimen (breast cancer)

Questionnaire EORTC QLQ-C30 is used to determine patients' health-related quality of life.

Questionnaire EORTC QLQ-CIPN20 is used to elicit patients' experience of symptoms and functional limitations related to CIPN.

Drug treatment of neuropathic pain is observed over the time of the OnLife® application and the month after the end of OnLife® application

Swiss Medical Food AG

iOMEDICO AG

open-label, single-institution proof of principle study of oral CLA in patients with newly diagnosed adenocarcinoma of the breast.

Women with histologically proven invasive non-metastatic breast cancer.

Single Arm Study

Sex: Female, Male

Region of Enrollment

To determine whether ≥ 10 days of CLA consumption suppresses Spot 14 expression in breast cancer tissue in vivo. The staining intensities scoring system used is: no immuostaining (0), weak staining (1), and strong staining (2). The scoring system used objectively and quantitatively assesses the expression of Spot 14, fatty acid synthase, and lipoprotein lipase using the image processing and analysis software Image-Pro Plus™ (MediaCybernetics).

Pre CLA

Post CLA

Number of Participants With Spot 14 Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry and Staining Intensities Scored at 0, 1, or 2

To determine whether ≥ 10 days of CLA consumption suppresses FASN expression in breast cancer tissue in vivo. The staining intensities scoring system used is: no immuostaining (0), weak staining (1), and strong staining (2). The scoring system used objectively and quantitatively assesses the expression of Spot 14, fatty acid synthase, and lipoprotein lipase using the image processing and analysis software Image-Pro Plus™ (MediaCybernetics).

Number of Participants With FASN Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry and Staining Intensities Scored at 0, 1, or 2

To determine whether ≥ 10 days of CLA consumption suppresses LPL expression in brest cancer tissue in vivo. The staining intensities scoring system used is: no immuostaining (0), weak staining (1), and strong staining (2). The scoring system used objectively and quantitatively assesses the expression of Spot 14, fatty acid synthase, and lipoprotein lipase using the image processing and analysis software Image-Pro Plus™ (MediaCybernetics).

Number of Participants With LPL Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry and Staining Intensities Scored at 0, 1, or 2

To determine whether ≥ 10 days of CLA consumption impacts the status of tumor proliferation by calculating the percentage of cells expressing Ki67.

All Study Participants

Number of Participants With Ki67 Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry

To determine whether ≥ 10 days of CLA consumption impacts the status of tumor cell apoptosis by measuring the presence of immunostaining for cleaved caspase 3.

Mean # of Stained Cells Per Microscope Field Pre CLA

Assess Tumor Cell Apoptosis by Immunostaining for Cleaved Caspase 3 Pre and Post CLA

Number of participants demonstrating a change in concentrations of CLA isomers in correlation to Spot 14 expression.

Correlation of CLA Isomers Matched to Spot 14 Expression

Number of Participants With Measurable Concentration of the Circulating Plasma Free CLA Isomers c9,t11 and t10,c12 Matched to Spot 14 Expression.

Number of participants demonstrating a change in concentrations of CLA isomers in correlation to Ki-67 expression.

Correlation of CLA Isomers Matched to Ki-67 Expression

Number of Participants With Measurable Concentration of the Circulating Plasma Free CLA Isomers c9t11 and t10c12 Matched to Ki-67 Expression

# of Grade 1 AEs Deemed "Possibly Related" to CLA

# of Grade 2 AEs Deemed "Possibly Related" to CLA

# of Grade 3 AEs Deemed "Possibly Related" to CLA

# of Grade 4 AEs Deemed "Possibly Related" to CLA

Safety of Short Term Treatment With 7.5 Gram CLA Per Day.

Conjugated Linoleic Acid

Overall Study

Burton Eisenberg, MD, Deputy Director, Norris Cotton Cancer Center

Women with histologically proven invasive, non metastatic breast cancer who received at least one day of CLA.

Subjects Taking 1 or More Doses of CLA

Conjugated linoleic acid (CLA, Clarinol™) oral soft gel capsules will be administered in an open-labeled, manner to all subjects enrolled in the study. Subjects will be treated with 7.5 grams of oral CLA daily, taken in divided dose, twice daily between 8 am and 12 noon and between 8 pm and 12 midnight. CLA will be taken for a minimum of ten days prior to surgical resection of their breast malignancy. In the event that the subject's surgical resection date is delayed, subjects may take CLA for up to 28 days. The last dose of CLA prior to the surgical resection will be taken at 12 midnight or as close as possible to that time and the patient will record the time of the last dosing.

Conjugated Linoleic Acid (CLA)

Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center

Proof of Principle Trial to Determine if Nutritional Supplement Conjugated Linoleic Acid (CLA) Can Modulate the Lipogenic Pathway in Breast Cancer Tissue

An in Vivo Proof of Principle Trial to Determine Whether the Nutritional Supplement Conjugated Linoleic Acid (CLA, Clarinol™) Can Modulate the Lipogenic Pathway in Breast Cancer Tissue

linoleic acid/bröstcancer

Cancer Activity and Lifestyle Measurement Study

Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy

Proof of Principle Trial to Determine if Nutritional Supplement Conjugated Linoleic Acid (CLA) Can Modulate the Lipogenic Pathway in Breast Cancer Tissue

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