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Nutritional Intervention-induced Weight Loss During the Oncological Treatment of Obesity-related Breast Cancer

NCT06046755 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-09-21

No results posted yet for this study

Summary

Obesity could become the first evitable cause of breast cancer in the near future. Due to the relatively slow rate of development in this field, greater efforts must be applied in this area. The HYPOTHESIS of this work is that "a therapy to lose weight in breast cancer women with obesity during the oncological treatment could contribute to slowing carcinogenesis, and to improve the response to the chemotherapy, survival and prevent future recurrences by erasing deleterious epigenetic marks". A group of breast cancer women with obesity (n=90) will be treated to lose weight during the oncologic treatment with a low calorie-ketogenic diet or a group educational intervention program of healthy lifestyle. The reversibility of the obesity-related breast cancer epigenetic signatures (EPIC array and pyrosequencing) and other molecular features (QRTPCR, ELISA assays) in blood leukocytes and plasma and the progression of disease will be compared with an obesity (n=30) and normalweight (n=30) group under conventional anticancer therapy. A matched-group of tumor-free women (n=60) with obesity will be also treated to lose weight with the same nutritional interventions and compared with tumor-free women with normal weight (n=30) in order to evaluate the potential preventive function of weight loss therapies on cancer-related odds. The outcomes of this project will directly benefit overweight and obese patients from healthcare systems, and also to have an economic value supporting pharmaceutical and food industry companies in the design of innovative treatments, useful biomarkers and preventive tools.

Conditions

Interventions

OTHER

Very low calorie ketogenic diet (VLCKD)

Weight loss therapies in patients with excess body weight based on a ketogenic diet

BEHAVIORAL

Group educational intervention program (IGOBE)

Balanced hypocaloric diet plus structured groupal program of habits change and exercise

Sponsors & Collaborators

  • Hospital Arquitecto Marcide

    collaborator OTHER

  • Hospital Clinico Universitario de Santiago

    lead OTHER

Principal Investigators

  • Ana B Crujeiras, Dr · Hospital Clinico Universitario de Santiago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2024-10-03
Completion
2025-12-21

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06046755 on ClinicalTrials.gov