Breast CancerMACSNCT04469296
Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery
A study testing iso-caloric ketogenic diet and protein restricted diet in people with Breast Cancer and Surgery, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
to analyze the feasibility for patients with early luminal breast cancer to be compliant with a diet modification - ketogenic or proteins restricted diet - during 9 +/- 1 days, before breast cancer surgery. It's a Pilot study, monocentric, randomized Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- iso-caloric ketogenic diet and protein restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 to 80 years old
- Invasive breast carcinoma, non-metastatic, stage I to III, pathologically proven, ER and/or PR positive, HER2 negative (luminal)
- No treatment yet for the current breast cancer
- Candidate for primary surgery
- Body mass index (BMI) between 18.5 and 30 for women up to 70 years old and between 21 and 30 for women between 70 and 80 years old.
- For patient ≥ 70 years, score of the Oncodage G8 questionnaire > 14 (if score ≤ 14, consultation with an oncogeriatrician required to validate the possibility of following a diet
Show all 12Show fewer
- No addiction (alcohol, tobacco, drug, electronic cigarette) that modifies the metabolism (alcohol : ≤ 2 glasses/d or ≤10 glasses/week ; tobacco : only occasional or stopped for ≥ 6 months)
- Performance status 0-1
- Fasting blood test :
- Blood cell counts : Neutrophils > 1000/µL, Platelets > 100 000/µL, Hb > 11g/dL Hepatic biology: GOT, GPT, GGT, Phosphatases alcalines < 2x normal value Renal function : clearance > 60 mL /min Lipid profile : Total cholesterol < 1.5 x normal value, HDL>0.35g/L, LDL < 2.2 g/L (<5.7 mml/L), Triglycerides < 1.5 x normal value Fasting blood glucose < 1.26 g/l Measurement of electrolytes: Potassium, Sodium, Calcium, Magnesium (according to normal laboratory values)
- ECG with a QTc interval ≤ 450 msec
- Patient able to understand, participate and give a written consent for participation to the study
Who cannot join
- Metabolic disease or other disease impairing the metabolism analysis
- High level athlete
- Unintentional weight loss ≥ 5% during the last month, or 10% during the last 6 months or compared to usual weight
- Unjustified dietary supplement (not justified by a measured deficiency) during the last month
- Restricted of unbalanced diet (vegan diet, restricted hypocaloric, hyper or hypo protein…) during the last month
- Practice of fasting during the last 3 months
Show all 14Show fewer
- Corticoids that can't be stopped or not stopped for 2 weeks
- Mellitus diabetes (with or without insulin)
- Hypercholesterolemia requiring a treatment
- Invasive lobular carcinoma
- Pregnant or breast-feeding women
- Participation to another study with an investigational treatment during the last 30 days
- Individuals under the protection of a conservator
- Unaffiliated patient to Social Protection System.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Icm Val D'Aurelle
Montpellier, Herault, 34298
Veronique D'HONDT, MD
About this study
Official title: Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery
to analyze the feasibility for patients with early luminal breast cancer to be compliant with a diet modification - ketogenic or proteins restricted diet - during 9 +/- 1 days, before breast cancer surgery.
It's a Pilot study, monocentric, randomized
Read the detailed description
Many patients are modifying their diet after the diagnosis of cancer. There is a supposedly benefit, among the general public, of starving cancer cells with several diet deprivations.
Due to the lack of coherent scientific data, no evidence base recommendations can be made regarding the optimal diet during cancer and its effect on cancer growth.
The objective of this trial is to analyze the feasibility for patients with early luminal breast cancer to be compliant with a diet modification - ketogenic or proteins restricted diet - during 9 +/- 1 days, before breast cancer surgery.
The primary objective of the trial is to evaluate the compliance to the proposed diet.
The study will be conducted in patients with luminal early breast cancer, candidate to primary surgery, in order to study an homogeneous population of patients, with good performance status and without nutritional deprivation.
Metabolic changes on the main metabolic pathways and the potential antitumor effects related to these metabolic changes following the diet will be analyzed as secondary objectives of the study. We hope to find biological hypotheses to further test in a next larger prospective trial.
The impact of the patient's beliefs, anxiety and/or depression on the compliance will be analyzed as well.
- Conditions
- Breast Cancer, Surgery
- Being tested
- iso-caloric ketogenic diet, protein restricted diet
- Keywords
- dietary survey,
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iso-caloric ketogenic dietDietary supplement
Each patient will be offered a daily diet plan that includes the different groups of low glycemic index foods to bring to each meal and snack, with the notion of quantity. Carbohydrate-free foods can be consumed ad libitum. Dietary advice will be given to increase the consumption of lipid foods (vegetable oils, butter, cheeses, fatty fish, etc.) so that 65% of the total energy intake is provided by lipids. In addition, a list of unauthorized sugars and sweeteners substitutes will be proposed as well as a low glycemic index food composition table centered on carbohydrates for better control of food choice
protein restricted dietDietary supplement
A diet reducing by 20% the amount of protein compared to the usual intake of the patient will be proposed. This new ration will be carried out by calculating the proportion of total energy intake provided by the amount of protein reduced by 20% compared to the usual intake, and by modifying lipid and carbohydrate intakes to obtain an isocaloric ration.
| Study group | Role | What they receive |
|---|---|---|
| control arm | No intervention | In the control arm, patients will continue their usual diet without further recommendation. |
| specific diet arm "Ketogenic arm" | Experimental | In the specific diet arms, the study diet will be calculated with a dietician, for the ketogenic diet, an iso-caloric ketogenic will be proposed and explained to the patient Each diet will be respected by the patient during 9 days +/- 1 day. Receives: Dietary Supplement: iso-caloric ketogenic diet |
| specofoc diet arm "protein restricted diet" | Experimental | In the specific diet arms, the study diet will be calculated with a dietician, for the protein restricted diet, a 20% protein restriction as compared to the usual diet will be calculated and the diet will be explained to the patient.
Each diet will be respected by the patient during 9 days +/- 1 day. Receives: Dietary Supplement: protein restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
study of the compliance of patients to the two proposed diets. The proportion of compliant patients to the proposed diet according to the dietary survey realized during 3 days
A patient is considered compliant to the diet if the caloric intake is equal +/- 25% to the caloric intake of the proposed diet AND For the ketogenic diet : the carbohydrate intake is equal +/- 25% to the carbohydrate intake of the proposed diet; i.e. a carbohydrate intake between 7.5 and 12.5% of the total energy intake For the protein restricted diet, the protein intake is equal +/- 25% to the protein intake proposed for this diet; i.e. a reduction between 15 and 25% compared to the previous protein intake
Measured: during 3 days before the primary surgery
Secondary outcomes (8)
study of the molecular consequences of diet modifications on cancer cells and their microenvironment
analyse markers of cell proliferation in cancer and immune cells with blood sample and tumor sample. Evaluation of markers involved in carbohydrate mitochondrial and lipid metabolism, and markers of the Pi3K-Akt-mTOR and the IGF-R pathways
Measured: At the inclusion visit and the day of surgery
study of the molecular consequences of diet modifications on cancer cells and their microenvironment
determine the activity of the anti-tumoral immune surveillance with blood sample and tumor sample. Correlation between the cancer response and antitumoral immune with diet programm
Measured: At the inclusion visit and the day of surgery
evaluation of patient's tolerability to those diet modifications, in terms of weight status
Weight surveillance (in kilograms)
Measured: From the inclusion visit until the Day 45 post surgery
evaluation of patient's tolerability to those diet modifications, in terms of adverse events
monitoring of adverse events related to diet (with CTCAE (Common Terminology Criteria for Adverse Events) version 5.0)
Measured: From the inclusion visit until the Day 45 post surgery
assessment of the acceptance of study participation and reasons for refusal
Rate of patients who agreed to participate in the study compared to the total number of patients to whom the study was proposed. Collection of reasons for refusing to participate to the study
Measured: During 45 days before the surgery
determination of the impact of diet modification on patient's quality of life
Result of the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) questionnaire
Measured: From the inclusion visit until the Day 45 post surgery
evaluation of the impact of patient's beliefs about diet and cancer on the compliance to the proposed diet.
Result of the questionnaire of Beliefs about diet and cancer OPINELE (Opinions concernant l'alimentation, la santé et le cancer)
Measured: From the inclusion visit until the Day 45 post surgery
evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet
Scores obtained on the HADS scale (Hospital Anxiety and Depression Scale) (if score or = 9, result is no significant, if sore is between 10 and 12, result is limit, if result is > or = 13, result is significant
Measured: From the inclusion visit until the Day 45 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start18 May 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique D'HONDT, MD, Study chair, ICM Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469296
- Sponsor's protocol ID
- PROICM 2019-05 MAC
- Acronym
- MACS
- Status last verified
- Jan 2026
- First submitted
- 6 Jul 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all disidentified participants' data, the study protocol, the statistical analysis plan, the clinical study report and the analytic code. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Publications
Kushi LH, Doyle C, McCullough M, Rock CL, Demark-Wahnefried W, Bandera EV, Gapstur S, Patel AV, Andrews K, Gansler T; American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee. American Cancer Society Guidelines on nutrition and physical activity for cancer prevention: reducing the risk of cancer with healthy food choices and physical activity. CA Cancer J Clin. 2012 Jan-Feb;62(1):30-67. doi: 10.3322/caac.20140.
PubMed 22237782Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26.
PubMed 22539238Cairns RA, Mak TW. Fire and water: Tumor cell adaptation to metabolic conditions. Exp Cell Res. 2017 Jul 15;356(2):204-208. doi: 10.1016/j.yexcr.2017.04.029. Epub 2017 Apr 27.
PubMed 28457987Vander Heiden MG, DeBerardinis RJ. Understanding the Intersections between Metabolism and Cancer Biology. Cell. 2017 Feb 9;168(4):657-669. doi: 10.1016/j.cell.2016.12.039.
PubMed 28187287Chen Y, Ling L, Su G, Han M, Fan X, Xun P, Xu G. Effect of Intermittent versus Chronic Calorie Restriction on Tumor Incidence: A Systematic Review and Meta-Analysis of Animal Studies. Sci Rep. 2016 Sep 22;6:33739. doi: 10.1038/srep33739.
PubMed 27653140Fontana L, Partridge L. Promoting health and longevity through diet: from model organisms to humans. Cell. 2015 Mar 26;161(1):106-118. doi: 10.1016/j.cell.2015.02.020.
PubMed 25815989Lv M, Zhu X, Wang H, Wang F, Guan W. Roles of caloric restriction, ketogenic diet and intermittent fasting during initiation, progression and metastasis of cancer in animal models: a systematic review and meta-analysis. PLoS One. 2014 Dec 11;9(12):e115147. doi: 10.1371/journal.pone.0115147. eCollection 2014.
PubMed 25502434O'Flanagan CH, Smith LA, McDonell SB, Hursting SD. When less may be more: calorie restriction and response to cancer therapy. BMC Med. 2017 May 24;15(1):106. doi: 10.1186/s12916-017-0873-x.
PubMed 28539118Weber DD, Aminzadeh-Gohari S, Tulipan J, Catalano L, Feichtinger RG, Kofler B. Ketogenic diet in the treatment of cancer - Where do we stand? Mol Metab. 2020 Mar;33:102-121. doi: 10.1016/j.molmet.2019.06.026. Epub 2019 Jul 27.
PubMed 31399389A D B. The Ketogenic Diet in Epilepsy. Can Med Assoc J. 1931 Jan;24(1):106-7. No abstract available.
PubMed 20318124
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery
- ClinicalTrials.gov ID
- NCT04469296
- Acronym / sponsor ID
- MACS / PROICM 2019-05 MAC
- Conditions
- Breast Cancer, Surgery
- Keywords
- dietary survey,
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jul 2020 (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.
to analyze the feasibility for patients with early luminal breast cancer to be compliant with a diet modification - ketogenic or proteins restricted diet - during 9 +/- 1 days, before breast cancer surgery.
It's a Pilot study, monocentric, randomized
Detailed description
Many patients are modifying their diet after the diagnosis of cancer. There is a supposedly benefit, among the general public, of starving cancer cells with several diet deprivations.
Due to the lack of coherent scientific data, no evidence base recommendations can be made regarding the optimal diet during cancer and its effect on cancer growth.
The objective of this trial is to analyze the feasibility for patients with early luminal breast cancer to be compliant with a diet modification - ketogenic or proteins restricted diet - during 9 +/- 1 days, before breast cancer surgery.
The primary objective of the trial is to evaluate the compliance to the proposed diet.
The study will be conducted in patients with luminal early breast cancer, candidate to primary surgery, in order to study an homogeneous population of patients, with good performance status and without nutritional deprivation.
Metabolic changes on the main metabolic pathways and the potential antitumor effects related to these metabolic changes following the diet will be analyzed as secondary objectives of the study. We hope to find biological hypotheses to further test in a next larger prospective trial.
The impact of the patient's beliefs, anxiety and/or depression on the compliance will be analyzed as well.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control arm | No intervention | –In the control arm, patients will continue their usual diet without further recommendation. |
| specific diet arm "Ketogenic arm" | Experimental | Dietary Supplement: iso-caloric ketogenic dietIn the specific diet arms, the study diet will be calculated with a dietician, for the ketogenic diet, an iso-caloric ketogenic will be proposed and explained to the patient Each diet will be respected by the patient during 9 days +/- 1 day. |
| specofoc diet arm "protein restricted diet" | Experimental | Dietary Supplement: protein restricted dietIn the specific diet arms, the study diet will be calculated with a dietician, for the protein restricted diet, a 20% protein restriction as compared to the usual diet will be calculated and the diet will be explained to the patient. Each diet will be respected by the patient during 9 days +/- 1 day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women 18 to 80 years old
- Invasive breast carcinoma, non-metastatic, stage I to III, pathologically proven, ER and/or PR positive, HER2 negative (luminal)
- No treatment yet for the current breast cancer
- Candidate for primary surgery
- Body mass index (BMI) between 18.5 and 30 for women up to 70 years old and between 21 and 30 for women between 70 and 80 years old.
Key exclusion criteria (14 listed)
- Metabolic disease or other disease impairing the metabolism analysis
- High level athlete
- Unintentional weight loss ≥ 5% during the last month, or 10% during the last 6 months or compared to usual weight
- Unjustified dietary supplement (not justified by a measured deficiency) during the last month
- Restricted of unbalanced diet (vegan diet, restricted hypocaloric, hyper or hypo protein…) during the last month
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 |
|---|---|---|
| iso-caloric ketogenic dietEach patient will be offered a daily diet plan that includes the different groups of low glycemic index foods to bring to each meal and snack, with the notion of quantity. Carbohydrate-free foods can be consumed ad libitum. Dietary advice will be given to increase the consumption of lipid foods (vegetable oils, butter, cheeses, fatty fish, etc.) so that 65% of the total energy intake is provided by lipids. In addition, a list of unauthorized sugars and sweeteners substitutes will be proposed as well as a low glycemic index food composition table centered on carbohydrates for better control of food choice | Dietary supplement | specific diet arm "Ketogenic arm" |
| protein restricted dietA diet reducing by 20% the amount of protein compared to the usual intake of the patient will be proposed. This new ration will be carried out by calculating the proportion of total energy intake provided by the amount of protein reduced by 20% compared to the usual intake, and by modifying lipid and carbohydrate intakes to obtain an isocaloric ration. | Dietary supplement | specofoc diet arm "protein restricted diet" |
Primary outcome
study of the compliance of patients to the two proposed diets. The proportion of compliant patients to the proposed diet according to the dietary survey realized during 3 days
Time frame: during 3 days before the primary surgery
A patient is considered compliant to the diet if the caloric intake is equal +/- 25% to the caloric intake of the proposed diet AND For the ketogenic diet : the carbohydrate intake is equal +/- 25% to the carbohydrate intake of the proposed diet; i.e. a carbohydrate intake between 7.5 and 12.5% of the total energy intake For the protein restricted diet, the protein intake is equal +/- 25% to the protein intake proposed for this diet; i.e. a reduction between 15 and 25% compared to the previous protein intake
8 secondary outcomes
study of the molecular consequences of diet modifications on cancer cells and their microenvironment
Time frame: At the inclusion visit and the day of surgery
study of the molecular consequences of diet modifications on cancer cells and their microenvironment
Time frame: At the inclusion visit and the day of surgery
evaluation of patient's tolerability to those diet modifications, in terms of weight status
Time frame: From the inclusion visit until the Day 45 post surgery
evaluation of patient's tolerability to those diet modifications, in terms of adverse events
Time frame: From the inclusion visit until the Day 45 post surgery
assessment of the acceptance of study participation and reasons for refusal
Time frame: During 45 days before the surgery
determination of the impact of diet modification on patient's quality of life
Time frame: From the inclusion visit until the Day 45 post surgery
evaluation of the impact of patient's beliefs about diet and cancer on the compliance to the proposed diet.
Time frame: From the inclusion visit until the Day 45 post surgery
evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet
Time frame: From the inclusion visit until the Day 45 post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Results publication: PubMed 22237782Kushi LH, Doyle C, McCullough M, Rock CL, Demark-Wahnefried W, Bandera EV, Gapstur S, Patel AV, Andrews K, Gansler T; American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee. American Cancer Society Guidelines on nutrition and physical activity for cancer prevention: reducing the risk of cancer with healthy food choices and physical activity. CA Cancer J Clin. 2012 Jan-Feb;62(1):30-67. doi: 10.3322/caac.20140.
- Results publication: PubMed 22539238Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26.
- Results publication: PubMed 28457987Cairns RA, Mak TW. Fire and water: Tumor cell adaptation to metabolic conditions. Exp Cell Res. 2017 Jul 15;356(2):204-208. doi: 10.1016/j.yexcr.2017.04.029. Epub 2017 Apr 27.
- Results publication: PubMed 28187287Vander Heiden MG, DeBerardinis RJ. Understanding the Intersections between Metabolism and Cancer Biology. Cell. 2017 Feb 9;168(4):657-669. doi: 10.1016/j.cell.2016.12.039.
- Results publication: PubMed 27653140Chen Y, Ling L, Su G, Han M, Fan X, Xun P, Xu G. Effect of Intermittent versus Chronic Calorie Restriction on Tumor Incidence: A Systematic Review and Meta-Analysis of Animal Studies. Sci Rep. 2016 Sep 22;6:33739. doi: 10.1038/srep33739.
- Results publication: PubMed 25815989Fontana L, Partridge L. Promoting health and longevity through diet: from model organisms to humans. Cell. 2015 Mar 26;161(1):106-118. doi: 10.1016/j.cell.2015.02.020.
- Results publication: PubMed 25502434Lv M, Zhu X, Wang H, Wang F, Guan W. Roles of caloric restriction, ketogenic diet and intermittent fasting during initiation, progression and metastasis of cancer in animal models: a systematic review and meta-analysis. PLoS One. 2014 Dec 11;9(12):e115147. doi: 10.1371/journal.pone.0115147. eCollection 2014.
- Results publication: PubMed 28539118O'Flanagan CH, Smith LA, McDonell SB, Hursting SD. When less may be more: calorie restriction and response to cancer therapy. BMC Med. 2017 May 24;15(1):106. doi: 10.1186/s12916-017-0873-x.
- Results publication: PubMed 31399389Weber DD, Aminzadeh-Gohari S, Tulipan J, Catalano L, Feichtinger RG, Kofler B. Ketogenic diet in the treatment of cancer - Where do we stand? Mol Metab. 2020 Mar;33:102-121. doi: 10.1016/j.molmet.2019.06.026. Epub 2019 Jul 27.
- Results publication: PubMed 20318124A D B. The Ketogenic Diet in Epilepsy. Can Med Assoc J. 1931 Jan;24(1):106-7. No abstract available.
- Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all disidentified participants' data, the study protocol, the statistical analysis plan, the clinical study report and the analytic code. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
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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.
Veronique D'HONDT, MD study chair
ICM Val d'Aurelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iso-caloric ketogenic diet and protein restricted diet in people with Breast Cancer and Surgery, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 12 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurore Moussion (04 67 61 31 02 ext. +33, DRCI-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study of the compliance of patients to the two proposed diets. The proportion of compliant patients to the proposed diet according to the dietary survey realized during 3 days (time frame: during 3 days before the primary surgery). 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 NCT04469296, which also lists 10 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 16 Jan 2026.