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

NCT05234502 | Unknown

• 1 other identifier: Ketogenic Diet
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

neoadjuvant chemotherapy; ketogenic diet; polyneuropathy

Outcome Measures

Primary Outcomes (6)

• Polyneuropathy

  Chemotherapy-induced polyneuropathy will be assessed through EORTC QLQ-CIPN20.

  6 months (before and after neoadjuvant therapy)

• Polyneuropathy-severity of symptoms

  Severity of symptoms of polyneuropathy will be assessed through National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)

  6 months (before and after neoadjuvant therapy)

• Tumor size

  Before and after neoadjuvant therapy, routine radiological imaging report will be evaluated.

  6 months (before and after neoadjuvant therapy)

• Quality of life score-(European Cancer Research and Treatment Organization Quality of Life Scale - Cancer 30 (EORTC QLQ-C30)

  The quality of life of women with breast cancer is evaluated with the European Cancer Research and Treatment Organization Quality of Life Scale - Cancer 30 (EORTC QLQ-C30). It consists of 30 items to assess physical, role, emotional, cognitive and social functioning, global health status or qualitiy of life scales, fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties.

  6 months (before and after neoadjuvant therapy)

• Quality of life score-Case group (the European Cancer Research and Treatment Organization Breast Cancer-Specific Quality of Life Scale

  The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.

  6 months (before and after neoadjuvant therapy)

• 5-year survival rate

  After neoadjuvant therapy survival rates will be evaluated.

  5 years after neoadjuvant therapy

Study Arms (2)

Group-1 (Ketogenic diet)

EXPERIMENTAL

Group-1 will be given an adequate and balanced healthy diet program during the standard neoadjuvant treatment (12 weeks) with an anthracycline. And simultaneously with standard neoadjuvant therapy containing taxane (12 weeks), KD will be planned for Group-1

Other: Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%); Other: Ketogenic diet program (CHO: 6%, protein:19%, fat:75%)

Group-2 (Adequate and balanced healthy diet)

OTHER

Group-2 will be given an adequate and balanced healthy diet program during the standard neoadjuvant treatment (12 weeks) with anthracycline and taxane (12 weeks).

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

Interventions

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

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.

Group-1 (Ketogenic diet); Group-2 (Adequate and balanced healthy diet)

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

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

Group-1 (Ketogenic diet)

Eligibility Criteria

• Age: 19 Years - 64 Years
• Gender Eligibility Details: Breast cancer occurs almost entirely in females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with breast cancer for the first time,
• Planned to receive neoadjuvant treatment,
• Being overweight (BMI: 25-29.9 kg/m2) or obese (BMI: ≥30 kg/m2),
• Karnofsky Performance Score ≥ 70

You may not qualify if:

• Ketogenic diet history,
• Diagnosed with moderate/severe neurological and/or cognitive impairment
• Diagnosed with kidney, liver, and gall bladder disease/coronary artery disease
• Diagnosed with type 1 diabetes,
• Diagnosed with type 2 diabetes using oral antidiabetic or insulin,
• Diagnosed with eating behavior disorder (anorexia nervosa, bulimia nervosa, binge eating disorder),
• Using weight loss medication,
• Karnofsky Performance Score \< 70,
• Pregnant
• Breastfeeding individuals

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Related Publications (6)

• National Cancer Institute. 2017.

  BACKGROUND

• Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.

  PMID: 15911236 BACKGROUND

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 BACKGROUND

• Khodabakhshi A, Akbari ME, Mirzaei HR, Mehrad-Majd H, Kalamian M, Davoodi SH. Feasibility, Safety, and Beneficial Effects of MCT-Based Ketogenic Diet for Breast Cancer Treatment: A Randomized Controlled Trial Study. Nutr Cancer. 2020;72(4):627-634. doi: 10.1080/01635581.2019.1650942. Epub 2019 Sep 9.

  PMID: 31496287 BACKGROUND

• Khodabakhshi A, Akbari ME, Mirzaei HR, Seyfried TN, Kalamian M, Davoodi SH. Effects of Ketogenic metabolic therapy on patients with breast cancer: A randomized controlled clinical trial. Clin Nutr. 2021 Mar;40(3):751-758. doi: 10.1016/j.clnu.2020.06.028. Epub 2020 Jul 3.

  PMID: 32703721 BACKGROUND

• Khodabakhshi A, Seyfried TN, Kalamian M, Beheshti M, Davoodi SH. Does a ketogenic diet have beneficial effects on quality of life, physical activity or biomarkers in patients with breast cancer: a randomized controlled clinical trial. Nutr J. 2020 Aug 22;19(1):87. doi: 10.1186/s12937-020-00596-y.

  PMID: 32828130 BACKGROUND

Related Links

• Sample Size Calculator

MeSH Terms

Conditions

Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Şenay Burçin ALKAN, MSc

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet ARTAÇ, MD

CONTACT

03322236434; martac@erbakan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor Doctor

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 10, 2022
• Study Start: January 30, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2025
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share