Clinical trial · Interventional

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

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

NCT05234502CI-TRIAL-00056454unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer Female	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%)	Other	—	UNRESOLVED
Ketogenic diet program (CHO: 6%, protein:19%, fat:75%)	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Group-1 (Ketogenic diet)
description
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
interventionNames
1. Other: Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%)
2. Other: Ketogenic diet program (CHO: 6%, protein:19%, fat:75%)
type
OTHER
label
Group-2 (Adequate and balanced healthy diet)
description
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).
interventionNames
1. Other: Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%)

Primary outcomes (6)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 19 Years
Maximum age: 64 Years

Show eligibility criteria text

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

References

Publications (6)

BACKGROUNDNational Cancer Institute. 2017.
BACKGROUNDPostma 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
BACKGROUNDAaronson 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
BACKGROUNDKhodabakhshi 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
BACKGROUNDKhodabakhshi 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
BACKGROUNDKhodabakhshi 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