Effects of Ketogenic Diet in Overweight and Obese Women With Breast Cancer

Summary

Breast cancer is the most common cancer type among women in Turkey and the world. Chemotherapy, surgery, radiotherapy, immunotherapy and hormone therapy are used in the treatment. Nutrition is one of the important factors affects cancer treatment. In recent years, there has been an increase in the number of clinical studies on the ketogenic diet (KD) in different types of cancer. In the literature, it has been shown the KD applied with chemotherapy improves the quality of life and decreases the body weight and tumour size in women with breast cancer. However, there is no comprehensive study evaluating the effect of KD on chemotherapy-induced sensory and motor neuropathy and survival in breast cancer patients. In this project, the KD will be planned for overweight and obese women diagnosed with breast cancer who will be treated with neoadjuvant chemotherapy. Tumour size, nutritional status, biochemical findings, anthropometric measurements, quality of life, sensory and motor polyneuropathy and survival will be evaluated. Fifty-six women with breast cancer who comply with the study criteria and are willing to participate in the study will be given an adequate and balanced healthy diet program during the standard neoadjuvant treatment (12 weeks) with anthracycline. After the interim evaluation, individuals will be randomly divided into two groups. Simultaneously with standard neoadjuvant therapy containing taxane (12 weeks), KD will be planned for the first group and the second group will continue on the adequate and balanced healthy diet program. After neoadjuvant therapy, the effects of diets on prognosis and other factors (nutritional status, biochemical findings, anthropometric measurements, quality of life, sensory and motor polyneuropathy, and survival) will be compared. In this study, unlike other studies, the first data on the effect of KD on chemotherapy-induced polyneuropathy and pathological response in women with breast cancer will be obtained. In this respect, it has the potential for nutritional practices in clinical oncology. The KD could improve body composition and the complications related to obesity and decrease polyneuropathy. Therefore, drug-using and application to the hospital could decrease. The results of the project will contribute to the improvement of the health and the quality of life of women, who are the most important element of society and the family.

Conditions

• Breast Cancer Female

Interventions

OTHER

Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%)

In calculating the estimated basal metabolic rate of individuals, Mifflin-St. The Jeor Equation will be used.BMR will be multiplied by the physical activity factor of the individual and 500\*700 kcal will be subtracted from the found value and the total daily energy requirement will be obtained.

OTHER

Ketogenic diet program (CHO: 6%, protein:19%, fat:75%)

A ketogenic diet will be applied to Group 1 for 12 weeks simultaneously with taxane treatment.

Sponsors & Collaborators

• Necmettin Erbakan University

  lead OTHER

Principal Investigators

• Şenay Burçin ALKAN, MSc · Necmettin Erbakan University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

64 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-30

Primary Completion

2024-01-30

Completion

2025-01-30