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Trial record 7 of 192 for:    Oral Cancer | ( Map: Mexico )

Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03625635
Recruitment Status : Active, not recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Humberto Francisco Astiazaran Garcia, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.

Tracking Information
First Submitted Date  ICMJE August 8, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date August 10, 2018
Actual Study Start Date  ICMJE September 14, 2015
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Total body weight [ Time Frame: baseline and after the 6-mo food-based intervention ]
change in body weight (kilograms)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • Body fat mass [ Time Frame: baseline and after the 6-mo food-based intervention ]
    change in body fat mass (kilograms)
  • Body fat-free mass [ Time Frame: baseline and after the 6-mo food-based intervention ]
    change in fat-free mass (kilograms)
  • Skeletal muscle mass [ Time Frame: baseline and after the 6-mo food-based intervention ]
    change in skeletal muscle mass (kilograms)
  • Waist circumference [ Time Frame: baseline and after the 6-mo food-based intervention ]
    change in waist circumference (centimeters)
  • Retinol [ Time Frame: baseline and after the 6-mo food-based intervention ]
    change in retinol μmol /L
  • Trolox-equivalent antioxidant capacity test [ Time Frame: baseline and after the 6-mo food-based intervention ]
    change in trolox equivalents per liter
  • Glutathione peroxidase (GPx) [ Time Frame: baseline and after the 6-mo food-based intervention ]
    change in glutathione peroxidase concentration (ng/mL)
  • Superoxide dismutase (SOD) [ Time Frame: baseline and after the 6-mo food-based intervention ]
    change in superoxide dismutase concentration (ng/mL)
  • Human inflammatory cytokines [ Time Frame: baseline and after the 6-mo food-based intervention ]
    change in IL1A, IL1B, IL2, IL4, IL6, IL8, IL10, IL12, IL17A, IFNg, TNFa, and GM-CSF (pg/mL)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment
Official Title  ICMJE Effect of a Clinical Nutrition Intervention Program on Body Composition, Metabolism and Antioxidant Activity Associated With Micronutrients in Breast Cancer Patients During Antineoplastic Treatment
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 study's 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 individual's nutritional status, dietary habits, symptoms and treatment side-effects, socioeconomic and cultural preferences; as well as the WCRF/AICR guidelines adapting 1.5g/kg/d of dietary protein to avoid sarcopenic obesity and considering a caloric restriction (500-1000 kcal/d), 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 (g/day) meets the theoretical calculations, protein ±1g/d, total fat ±1g/d, carbohydrates ±2g/d and energy ±15 kcal/d 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 Student's t-test analysis for each variable. A two-tailed P-value of 0.05 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 chloroform:methanol (3:1) 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, 4.6 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 < 1.05 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. Tukey's test will be used for the comparison of the means. Values of p<0.05 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 0.066 ng/mL and 1.56 ng/mL for GPx.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Masking during data analysis. Technicians and investigators will not be aware of the participants personal data and particularities.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Neoplasm
  • Breast Cancer
Intervention  ICMJE Other: Individualized food-based intervention
Diet plans and recommendations will be based on the individual's nutritional status, symptoms and treatment side-effects, socioeconomic and cultural preferences; as well as the WCRF/AICR guidelines adapting 1.5g/kg/d of dietary protein and when required, a caloric restriction (500-1000 kcal/d). Garlic and cruciferous vegetables will be encouraged as well as 5-9 servings of fruits and vegetables a day. The program will be based on the macronutrient meal-equivalent menu method, and standard food servings will be based on the Mexican Food Equivalent System. 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.
Study Arms  ICMJE Experimental: Nutrition diagnosis and intervention
At baseline and 6-mo after, a nutrition diagnosis will be done by measuring body composition components with DXA and basic anthropometric measurements. Based on the results, an individualized food-based intervention will be prescribed for each patient according to her diagnosis, food preferences, cultural and socioeconomic status. 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 are repeated.
Intervention: Other: Individualized food-based intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 9, 2018)
34
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • nonmetastatic breast cancer patient
  • before antineoplastic treatment initiation

Exclusion Criteria:

  • bone fracture(s)
  • disease(s) that could affect body composition (i.e. hypothyroidism)
  • disease(s) that would require an additional dietary therapeutic approach or consideration (i.e. diabetes)
  • dietary supplement consumption
  • body dimensions surpassed the equipment's capacity

Elimination Criteria:

  • newly diagnosed disease(s) that could affect body composition (i.e. hypothyroidism)
  • newly diagnosed disease(s) that would require an additional dietary therapeutic approach or consideration (i.e. diabetes)
  • dietary supplement consumption during the intervention
  • patient's decision to refuse or stop antineoplastic treatment
  • patient's decision to quit the intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03625635
Other Study ID Numbers  ICMJE CE/005/2015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Humberto Francisco Astiazaran Garcia, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.
Study Sponsor  ICMJE Humberto Francisco Astiazaran Garcia, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Humberto Astiazaran-Garcia, PhD Centro de Investigacion en Alimentacion y Desarrollo (CIAD)
PRS Account Centro de Investigación en Alimentación y Desarrollo A.C.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP