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

Effect of a Clinical Nutrition Intervention Program on Body Composition, Metabolism and Antioxidant Activity Associated With Micronutrients in Breast Cancer Patients During Antineoplastic Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Breast Neoplasm
• Intervention / Treatment: Other: Individualized food-based intervention

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Sonora
    • Hermosillo, Sonora, Mexico, 83304
      • Centro de Investigacion en Alimentacion y Desarollo (CIAD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total body weight	change in body weight (kilograms)	baseline and after the 6-mo food-based intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat mass	change in body fat mass (kilograms)	baseline and after the 6-mo food-based intervention
Body fat-free mass	change in fat-free mass (kilograms)	baseline and after the 6-mo food-based intervention
Skeletal muscle mass	change in skeletal muscle mass (kilograms)	baseline and after the 6-mo food-based intervention
Waist circumference	change in waist circumference (centimeters)	baseline and after the 6-mo food-based intervention
Retinol	change in retinol μmol /L	baseline and after the 6-mo food-based intervention
Trolox-equivalent antioxidant capacity test	change in trolox equivalents per liter	baseline and after the 6-mo food-based intervention
Glutathione peroxidase (GPx)	change in glutathione peroxidase concentration (ng/mL)	baseline and after the 6-mo food-based intervention
Superoxide dismutase (SOD)	change in superoxide dismutase concentration (ng/mL)	baseline and after the 6-mo food-based intervention
Human inflammatory cytokines	change in IL1A, IL1B, IL2, IL4, IL6, IL8, IL10, IL12, IL17A, IFNg, TNFa, and GM-CSF (pg/mL)	baseline and after the 6-mo food-based intervention

Collaborators and Investigators

• Sponsor: Humberto Francisco Astiazaran Garcia, PhD
• Investigators: Study Director: Humberto Astiazaran-Garcia, PhD, Centro de Investigacion en Alimentacion y Desarrollo (CIAD)

Publications and helpful links

General Publications

• Limon-Miro AT, Valencia ME, Lopez-Teros V, Aleman-Mateo H, Mendez-Estrada RO, Pacheco-Moreno BI, Astiazaran-Garcia H. An individualized food-based nutrition intervention reduces visceral and total body fat while preserving skeletal muscle mass in breast cancer patients under antineoplastic treatment. Clin Nutr. 2021 Jun;40(6):4394-4403. doi: 10.1016/j.clnu.2021.01.006. Epub 2021 Jan 9.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2015
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: primary noninvasive breast cancer; sarcopenic obesity prevention; individualized nutrition intervention; food-based intervention
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CE/005/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No