Breast Cancer FemaleNCT05234502
Effects of Ketogenic Diet in Overweight and Obese Women With Breast Cancer
A study testing Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%) and Ketogenic diet program (CHO: 6%, protein:19%, fat:75%) in people with Breast Cancer Female, run by Necmettin Erbakan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%) and Ketogenic diet program (CHO: 6%, protein:19%, fat:75%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2022to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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),
Show all 10Show fewer
- Using weight loss medication,
- Karnofsky Performance Score < 70,
- Pregnant
- Breastfeeding individuals
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Ketogenic Diet on Metabolism and Polyneuropathy in Overweight and Obese Women With Breast Cancer
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.
Read the detailed description
The study was designed as a randomized prospective study.
The Location of the Research: The research will be carried out in Konya Necmettin Erbakan University Meram Faculty of Medicine, Departments of General Surgery, Medical Oncology, and Medical Biochemistry. Ethics committee approval was obtained from the Ethics Committee of Necmettin Erbakan University, (Date:03.09.2021, Number:2021/3378). And the official approval was obtained from the Necmettin Erbakan University Meram Medical Faculty Hospital Chief Physician to conduct the study.
The Sample Size of the Study: The study will include overweight and obese female individuals aged 19-64 who volunteered to participate in the study, diagnosed with breast cancer, who applied to Necmettin Erbakan University Meram Faculty of Medicine, Department of General Surgery and planned to receive neoadjuvant treatment in the Department of Medical Oncology. Since the ketogenic diet provides a decrease in body weight and an improvement in body composition, it was decided to include overweight and obese women. Neoadjuvant chemotherapy containing anthracycline and taxane is applied as standard to breast cancer patients in the Department of Medical Oncology of Meram Faculty of Medicine. After neoadjuvant therapy containing anthracyclines, patients will be randomly divided into two groups. A ketogenic diet will be applied to the first group (Group 1), and an adequate and balanced healthy nutrition program will be applied to the second group (Group 2).
The sample size of the study: Considering that the number of samples in Group 1 and Group 2 would be equal, it was determined that both groups should consist of at least 28 individuals with an error margin of d =3, α = 0.05, and a power of 0.90 power and 15% drop rate. In this study, all of the patients participating in the research will be informed in detail and informed consent forms will be obtained from all participants.
Statistical analysis: The data will be assessed using the SPSS 26 statistical software package. Mean, standard deviation, minimum and maximum values of the quantitative data will be calculated, and the number and percentage tables of the qualitative data will be created. In the comparison of quantitative data of Group 1 and 2, the Student t-test will be used for the normal distribution, and the Mann-Whitney U test will be used for the non-normal distribution. The chi-squared test will be used to evaluate qualitative data.
In the comparison of quantitative data of the groups during follow-up one-way ANOVA will be used for the normal distribution, and the Friedman test will be used for the non-normal distribution
- Conditions
- Breast Cancer Female
- Being tested
- Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%), Ketogenic diet program (CHO: 6%, protein:19%, fat:75%)
- Keywords
- neoadjuvant chemotherapy, ketogenic diet, polyneuropathy
- Medical subject headings
- Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Other: Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyneuropathy
Chemotherapy-induced polyneuropathy will be assessed through EORTC QLQ-CIPN20.
Measured: 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)
Measured: 6 months (before and after neoadjuvant therapy)
Tumor size
Before and after neoadjuvant therapy, routine radiological imaging report will be evaluated.
Measured: 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.
Measured: 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.
Measured: 6 months (before and after neoadjuvant therapy)
5-year survival rate
After neoadjuvant therapy survival rates will be evaluated.
Measured: 5 years after neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start30 Jan 2022 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Artac, Necmettin Erbakan University
- Investigators
- Şenay Burçin ALKAN, MSc, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234502
- Sponsor's protocol ID
- Ketogenic Diet
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Cancer Institute. 2017.
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.
PubMed 15911236Aaronson 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.
PubMed 8433390Khodabakhshi 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.
PubMed 31496287Khodabakhshi 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.
PubMed 32703721Khodabakhshi 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.
PubMed 32828130
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketogenic Diet on Metabolism and Polyneuropathy in Overweight and Obese Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT05234502
- Acronym / sponsor ID
- Ketogenic Diet
- Conditions
- Breast Cancer Female
- Keywords
- neoadjuvant chemotherapy, ketogenic diet, polyneuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was designed as a randomized prospective study.
The Location of the Research: The research will be carried out in Konya Necmettin Erbakan University Meram Faculty of Medicine, Departments of General Surgery, Medical Oncology, and Medical Biochemistry. Ethics committee approval was obtained from the Ethics Committee of Necmettin Erbakan University, (Date:03.09.2021, Number:2021/3378). And the official approval was obtained from the Necmettin Erbakan University Meram Medical Faculty Hospital Chief Physician to conduct the study.
The Sample Size of the Study: The study will include overweight and obese female individuals aged 19-64 who volunteered to participate in the study, diagnosed with breast cancer, who applied to Necmettin Erbakan University Meram Faculty of Medicine, Department of General Surgery and planned to receive neoadjuvant treatment in the Department of Medical Oncology. Since the ketogenic diet provides a decrease in body weight and an improvement in body composition, it was decided to include overweight and obese women. Neoadjuvant chemotherapy containing anthracycline and taxane is applied as standard to breast cancer patients in the Department of Medical Oncology of Meram Faculty of Medicine. After neoadjuvant therapy containing anthracyclines, patients will be randomly divided into two groups. A ketogenic diet will be applied to the first group (Group 1), and an adequate and balanced healthy nutrition program will be applied to the second group (Group 2).
The sample size of the study: Considering that the number of samples in Group 1 and Group 2 would be equal, it was determined that both groups should consist of at least 28 individuals with an error margin of d =3, α = 0.05, and a power of 0.90 power and 15% drop rate. In this study, all of the patients participating in the research will be informed in detail and informed consent forms will be obtained from all participants.
Statistical analysis: The data will be assessed using the SPSS 26 statistical software package. Mean, standard deviation, minimum and maximum values of the quantitative data will be calculated, and the number and percentage tables of the qualitative data will be created. In the comparison of quantitative data of Group 1 and 2, the Student t-test will be used for the normal distribution, and the Mann-Whitney U test will be used for the non-normal distribution. The chi-squared test will be used to evaluate qualitative data.
In the comparison of quantitative data of the groups during follow-up one-way ANOVA will be used for the normal distribution, and the Friedman test will be used for the non-normal distribution
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-1 (Ketogenic diet) | Experimental | 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-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 |
| Group-2 (Adequate and balanced healthy diet) | Other | Other: Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%)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). |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group-1 (Ketogenic diet), Group-2 (Adequate and balanced healthy diet) |
| 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. | Other | Group-1 (Ketogenic diet) |
Primary outcome
Polyneuropathy
Time frame: 6 months (before and after neoadjuvant therapy)
Chemotherapy-induced polyneuropathy will be assessed through EORTC QLQ-CIPN20.
Polyneuropathy-severity of symptoms
Time frame: 6 months (before and after neoadjuvant therapy)
Severity of symptoms of polyneuropathy will be assessed through National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
Tumor size
Time frame: 6 months (before and after neoadjuvant therapy)
Before and after neoadjuvant therapy, routine radiological imaging report will be evaluated.
Quality of life score-(European Cancer Research and Treatment Organization Quality of Life Scale - Cancer 30 (EORTC QLQ-C30)
Time frame: 6 months (before and after neoadjuvant therapy)
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.
Quality of life score-Case group (the European Cancer Research and Treatment Organization Breast Cancer-Specific Quality of Life Scale
Time frame: 6 months (before and after neoadjuvant therapy)
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.
5-year survival rate
Time frame: 5 years after neoadjuvant therapy
After neoadjuvant therapy survival rates will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- BackgroundNational Cancer Institute. 2017.
- Background: PubMed 15911236Postma 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.
- Background: PubMed 8433390Aaronson 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.
- Background: PubMed 31496287Khodabakhshi 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.
- Background: PubMed 32703721Khodabakhshi 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.
- Background: PubMed 32828130Khodabakhshi 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.
- Sample Size CalculatorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şenay Burçin ALKAN, MSc principal investigator
Necmettin Erbakan University
Questions about this trial
What is this clinical trial studying?
A study testing Adequate and balanced healthy diet program (CHO: 45-60%, protein:10-20%, fat:20-35%) and Ketogenic diet program (CHO: 6%, protein:19%, fat:75%) in people with Breast Cancer Female, run by Necmettin Erbakan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet ARTAÇ, MD (03322236434, martac@erbakan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyneuropathy (time frame: 6 months (before and after neoadjuvant therapy)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05234502, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.