Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
This double-blind, randomized crossover trial assessed inflammation and fatigue following a fast-food-type meal (saturated fat) compared to a healthier meal (monounsaturated fat) in breast cancer survivors and benign controls (women who had an initial abnormal test for breast cancer).
Interventions
OTHERSaturated Fat Meal
OTHEROleic Sunflower Oil Meal
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind: The data manager assigned arbitrary names to each meal so that only the data manager and the kitchen staff were unblinded.
Intervention model description
Randomized crossover trial: participants were randomized to sequence of meal type; they ate one high saturated fat meal and one high oleic sunflower oil meal with 1-4 weeks washout in between meals
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* We recruited a subset of a larger parent longitudinal observational study to participate in this study. Initially, participants were recruited following an abnormal mammogram, which resulted in either a malignant (cancer group) or benign (non-cancer control group) diagnosis.
Exclusion criteria
* A history of any prior cancer except basal or squamous cell, chronic obstructive pulmonary disease, evidence of liver or kidney failure, symptomatic ischemic heart disease, significant visual or auditory problems, cognitive impairment, major medical conditions involving the immune system such as diabetes, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, alcohol or drug abuse, marked and recurrent gastrointestinal problems, or regular use of medications with major immunological consequences, e.g., steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Meal Change in C-reactive Protein | Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal | Serum CRP was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions. |
| Post-Meal Change in Serum Amyloid A | Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal | Serum Amyloid A was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It as measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions. |
| Change in Intercellular adhesion molecule-1 | Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal | sICAM-1 was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions. |
| Change in Vascular cell adhesion molecule-1 | Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal | sVCAM-1 was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions. |
| Fatigue at Follow-Up Visits | The survey was administered upon admission to the Clinical Research Center before the meal at both visits and at 18- and 30-month follow-up visits. | The 30-item Multidimensional Fatigue Symptom Inventory-Short form assesses behavioral, cognitive, physical, and affective expressions of fatigue. It provides a very good measure of the multidimensional aspects of fatigue, allows for comparisons between fatigued and non-fatigued individuals, and has subscales measuring general, physical, emotional, mental, and vigor aspects of fatigue, as well as a total score. |
Countries
United States
Outcome results
None listed