Clinical trial · Interventional
Ketogenic Or LOGI Diet In a Breast Cancer Rehabilitation Intervention (KOLIBRI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to analyze if a ketogenic diet (KD) compared to either a "low glycämic and insulinemic" (LOGI) diet or to a standard diet (SD) is feasible, safe and tolerable and will improve quality of life and physical performance in patients with Breast Cancer during the rehabilitation phase. It will be an open-label trial of nutritional intervention for 20 weeks spanning three phases: 3 weeks of stationary intervention, 16 weeks of outhouse phase and one final week of stationary intervention.
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 |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental 1: Ketogenic diet (KD). | Other | — | UNRESOLVED |
| Experimental 2: "Low glycämic and insulinemic" diet (LOGI) | Other | — | UNRESOLVED |
| Standard diet (SD) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Standard diet
- description
- Standard diet (SD): Nutrition following the standard recommendations of the German society for nutrition
- interventionNames
- Other: Standard diet (SD)
- type
- EXPERIMENTAL
- label
- Ketogenic diet
- description
- Nutritional intervention: Ketogenic diet (KD). Intervention: Nutritional support (hospital) + self support (outpatient phase) with KD
- interventionNames
- Other: Experimental 1: Ketogenic diet (KD).
- type
- EXPERIMENTAL
- label
- Logi diet
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Consenting women aged 18 - 70 years. 2. Primary or recurrent breast cancer after primary standard therapy during the standard rehabilitation phase 3. Karnofsky Index \>70. 4. Willing and being able to follow the allocated dietary regime for 20 weeks Exclusion Criteria: 1. Patients with additional malignant tumors at the time of the recruitment 2. Participation at other trials 3. Dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study 4. Not able to follow the teaching due to deficits in teaching language (German) 5. Metabolic aberration banning fat rich nutrition or were a KD is contraindicated 6. Expected life span \< 12 month 7. Insulin dependent Diabetes 8. Decompensated heart failure (NYHA \> 2) 9. Myocardial infarction within the last 6 months, symptomatic atrial fibrillation 10. Severe acute infection 11. Pregnancy 12. Pancreatic insufficiency
References
Publications (12)
- BACKGROUNDWoolf EC, Scheck AC. The ketogenic diet for the treatment of malignant glioma. J Lipid Res. 2015 Jan;56(1):5-10. doi: 10.1194/jlr.R046797. Epub 2014 Feb 6. PMID 24503133
- BACKGROUNDKlement RJ, Frobel T, Albers T, Fikenzer S, Prinzhausen J, Kämmerer U. A pilot case study on the impact of a self-prescribed ketogenic diet on biochemical parameters and running performance in healthy and physically active individuals. NuMe 2013; 1(1):1-32
- BACKGROUNDFine EJ, Segal-Isaacson CJ, Feinman RD, Herszkopf S, Romano MC, Tomuta N, Bontempo AF, Negassa A, Sparano JA. Targeting insulin inhibition as a metabolic therapy in advanced cancer: a pilot safety and feasibility dietary trial in 10 patients. Nutrition. 2012 Oct;28(10):1028-35. doi: 10.1016/j.nut.2012.05.001. Epub 2012 Jul 26. PMID 22840388
- BACKGROUNDKossoff EH, Hartman AL. Ketogenic diets: new advances for metabolism-based therapies. Curr Opin Neurol. 2012 Apr;25(2):173-8. doi: 10.1097/WCO.0b013e3283515e4a. PMID 22322415
- BACKGROUNDKlement RJ, Kammerer U. Is there a role for carbohydrate restriction in the treatment and prevention of cancer? Nutr Metab (Lond). 2011 Oct 26;8:75. doi: 10.1186/1743-7075-8-75. PMID 22029671
- BACKGROUNDSeyfried TN, Marsh J, Shelton LM, Huysentruyt LC, Mukherjee P. Is the restricted ketogenic diet a viable alternative to the standard of care for managing malignant brain cancer? Epilepsy Res. 2012 Jul;100(3):310-26. doi: 10.1016/j.eplepsyres.2011.06.017. Epub 2011 Aug 31. PMID 21885251
- BACKGROUNDSchmidt M, Pfetzer N, Schwab M, Strauss I, Kammerer U. Effects of a ketogenic diet on the quality of life in 16 patients with advanced cancer: A pilot trial. Nutr Metab (Lond). 2011 Jul 27;8(1):54. doi: 10.1186/1743-7075-8-54. PMID 21794124
- Kossoff EH, Borsage JL, Comi AM. A pilot study of the modified Atkins diet for Sturge-Weber syndrome. Epilepsy Res. 2010 Dec;92(2-3):240-3. doi: 10.1016/j.eplepsyres.2010.09.008. Epub 2010 Oct 8.