Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03625635
Status:
UNKNOWN
Last Update Posted:
2018-08-10
First Post:
2018-08-08
Brief Title:
Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment
Sponsor:
Humberto Francisco Astiazaran Garcia PhD
Organization:
Centro de Investigación en Alimentación y Desarrollo AC
Study Overview
Official Title:
Effect of a Clinical Nutrition Intervention Program on Body Composition Metabolism and Antioxidant Activity Associated With Micronutrients in Breast Cancer Patients During Antineoplastic Treatment
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the effect of a 6-mo individualized and specialized food-based nutrition intervention program in breast cancer patients body composition metabolism and antioxidant activity associated with micronutrients during antineoplastic treatment
It is a quasi-experimental prospective follow-up study of women with primary diagnosis of invasive breast cancer in Sonora Mexico Conducted between September 2015 through July 2018 The Ethics and Research Committees of The Oncology State Centre and the Food and Development Research Centre have approved the studys protocol and procedures At baseline all participants must sign an informed consent form and answer an oral interview including self-reported questionnaires for their nutrition record
At the beginning and 6-mo after participants will be weighed during the morning in a digital scale and height will be measured using a digital stadiometer Body mass index BMI will be calculated and classified according to the World Health Organization criteria Waist and hip circumferences will be measured with a metal tape according to the protocol of the International Society for the Advancement of Kinanthropometry ISAK by a certified anthropometrist Body composition components will be measured in a dual-energy x-ray absorptiometry Hologic Corporation 4500 Waltham MA by total body L1-L4 and femur neck scans Blood samples will be drawn by a certified phlebotomist using sterile equipment and aseptic techniques
Breast cancer patients total energy expenditure will be estimated using an algorithm for Mexican population Diet plans and recommendations will be based on the individuals nutritional status dietary habits symptoms and treatment side-effects socioeconomic and cultural preferences as well as the WCRFAICR guidelines adapting 15gkgd of dietary protein to avoid sarcopenic obesity and considering a caloric restriction 500-1000 kcald when required The individualized nutrition intervention program will be based on the macronutrient meal-equivalent menu method and standard food servings will be based on the Mexican Food Equivalent System To guarantee that the obtained content for each macronutrient gday meets the theoretical calculations protein 1gd total fat 1gd carbohydrates 2gd and energy 15 kcald variations will be accepted
Breast cancer patients follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian unto 6-mo are completed and initial measurements will be repeated The differences in body composition determinants will be analyzed using paired Students t-test analysis for each variable A two-tailed P-value of 005 or less will be considered significant
Retinol tocopherol and carotenoids determination will be performed using HPLC Serum will be thawed and retinol will be extracted using chloroformmethanol 31 and hexane extracted layers will be combined and then evaporated to dryness under a soft stream of nitrogen Samples will be re-suspended in ethanol before injecting onto the HPLC using a YMC C-30 column 30 cm length 46 mm internal diameter 3 µm particle size and 100 mm pore size The HPLC system is an Agilent 1200 with UV-Vis and PDA detectors Commercial standards and internal standards will be used to assess concentration and extraction efficiency respectively Additionally the investigators will use a standard NIST serum National Institute of Standards and Technology Gaithersburg Maryland USA The cut-off point for vitamin A deficient status will be set at 105 μmol L
The plasma antioxidant capacity will be determined by the trolox-equivalent antioxidant capacity test TEAC and oxygen radical absorbance capacity assay ORAC For both assays results will be expressed as millimoles of Trolox equivalents per liter The effect and their interaction on the response variables will be determined by ANOVA Tukeys test will be used for the comparison of the means Values of p005 will be accepted as statistically significant
Human inflammatory cytokines and chemokines will be analyzed by using a panel of 12 pro-inflammatory cytokines as a conventional ELISA protocol all at once under uniform conditions The cytokines and chemokines represented by this array will be IL1A IL1B IL2 IL4 IL6 IL8 IL10 IL12 IL17A IFNg TNFa and GM-CSF
Plasma activities of both enzymes glutathione peroxidase GPx and superoxide dismutase SOD will be determined in baseline samples and after 6-mo by using an ELISA enzyme-linked immunosorbent assay based upon a sandwich assay principle and can be used to detect levels of SOD as low as 0066 ngmL and 156 ngmL for GPx
It is a quasi-experimental prospective follow-up study of women with primary diagnosis of invasive breast cancer in Sonora Mexico Conducted between September 2015 through July 2018 The Ethics and Research Committees of The Oncology State Centre and the Food and Development Research Centre have approved the studys protocol and procedures At baseline all participants must sign an informed consent form and answer an oral interview including self-reported questionnaires for their nutrition record
At the beginning and 6-mo after participants will be weighed during the morning in a digital scale and height will be measured using a digital stadiometer Body mass index BMI will be calculated and classified according to the World Health Organization criteria Waist and hip circumferences will be measured with a metal tape according to the protocol of the International Society for the Advancement of Kinanthropometry ISAK by a certified anthropometrist Body composition components will be measured in a dual-energy x-ray absorptiometry Hologic Corporation 4500 Waltham MA by total body L1-L4 and femur neck scans Blood samples will be drawn by a certified phlebotomist using sterile equipment and aseptic techniques
Breast cancer patients total energy expenditure will be estimated using an algorithm for Mexican population Diet plans and recommendations will be based on the individuals nutritional status dietary habits symptoms and treatment side-effects socioeconomic and cultural preferences as well as the WCRFAICR guidelines adapting 15gkgd of dietary protein to avoid sarcopenic obesity and considering a caloric restriction 500-1000 kcald when required The individualized nutrition intervention program will be based on the macronutrient meal-equivalent menu method and standard food servings will be based on the Mexican Food Equivalent System To guarantee that the obtained content for each macronutrient gday meets the theoretical calculations protein 1gd total fat 1gd carbohydrates 2gd and energy 15 kcald variations will be accepted
Breast cancer patients follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian unto 6-mo are completed and initial measurements will be repeated The differences in body composition determinants will be analyzed using paired Students t-test analysis for each variable A two-tailed P-value of 005 or less will be considered significant
Retinol tocopherol and carotenoids determination will be performed using HPLC Serum will be thawed and retinol will be extracted using chloroformmethanol 31 and hexane extracted layers will be combined and then evaporated to dryness under a soft stream of nitrogen Samples will be re-suspended in ethanol before injecting onto the HPLC using a YMC C-30 column 30 cm length 46 mm internal diameter 3 µm particle size and 100 mm pore size The HPLC system is an Agilent 1200 with UV-Vis and PDA detectors Commercial standards and internal standards will be used to assess concentration and extraction efficiency respectively Additionally the investigators will use a standard NIST serum National Institute of Standards and Technology Gaithersburg Maryland USA The cut-off point for vitamin A deficient status will be set at 105 μmol L
The plasma antioxidant capacity will be determined by the trolox-equivalent antioxidant capacity test TEAC and oxygen radical absorbance capacity assay ORAC For both assays results will be expressed as millimoles of Trolox equivalents per liter The effect and their interaction on the response variables will be determined by ANOVA Tukeys test will be used for the comparison of the means Values of p005 will be accepted as statistically significant
Human inflammatory cytokines and chemokines will be analyzed by using a panel of 12 pro-inflammatory cytokines as a conventional ELISA protocol all at once under uniform conditions The cytokines and chemokines represented by this array will be IL1A IL1B IL2 IL4 IL6 IL8 IL10 IL12 IL17A IFNg TNFa and GM-CSF
Plasma activities of both enzymes glutathione peroxidase GPx and superoxide dismutase SOD will be determined in baseline samples and after 6-mo by using an ELISA enzyme-linked immunosorbent assay based upon a sandwich assay principle and can be used to detect levels of SOD as low as 0066 ngmL and 156 ngmL for GPx
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None