Ketogenic Or LOGI Diet In a Breast Cancer Rehabilitation Intervention (KOLIBRI)

NCT02092753 | Completed

• 1 other identifier: KOLIBRI
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Quality of Life

Keywords

Ketogenic diet, logi diet, breast cancer, rehabilitation

Outcome Measures

Primary Outcomes (1)

• Quality of life

  To study the effect of a ketogenic diet (KD) or a low glycämic and insulinemic diet (LOGI) compared to a standard diet (SD) on quality of life in patients with Breast Cancer during the rehabilitation phase. This will be done by comparing the results of the EORTC QLQ-30 and the QLQ-BR23 questionnaires.

  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.

Secondary Outcomes (2)

• Safety

  see below (description)

• Tolerability

  see below

Study Arms (3)

Standard diet

PLACEBO COMPARATOR

Standard diet (SD): Nutrition following the standard recommendations of the German society for nutrition

Other: Standard diet (SD)

Ketogenic diet

EXPERIMENTAL

Nutritional intervention: Ketogenic diet (KD). Intervention: Nutritional support (hospital) + self support (outpatient phase) with KD

Other: Experimental 1: Ketogenic diet (KD).

Logi diet

EXPERIMENTAL

Nutritional intervention: low glycämic and insulinemic" diet (LOGI) Intervention: Nutritional support (hospital) + self support (outpatient phase) with LOGI

Other: Experimental 2: "Low glycämic and insulinemic" diet (LOGI)

Interventions

Standard diet (SD) OTHER

Nutrition intervention following the recommendations of the germans society for nutrition (DGE)

Standard diet

Experimental 1: Ketogenic diet (KD). OTHER

Nutritional intervention: recommendations to follow a ketogenic diet

Ketogenic diet

Experimental 2: "Low glycämic and insulinemic" diet (LOGI) OTHER

Nutritional intervention: patients were instructed to follow the "LOGI" diet regimen

Logi diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting women aged 18 - 70 years.
• Primary or recurrent breast cancer after primary standard therapy during the standard rehabilitation phase
• Karnofsky Index \>70.
• Willing and being able to follow the allocated dietary regime for 20 weeks

You may not qualify if:

• Patients with additional malignant tumors at the time of the recruitment
• Participation at other trials
• 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
• Not able to follow the teaching due to deficits in teaching language (German)
• Metabolic aberration banning fat rich nutrition or were a KD is contraindicated
• Expected life span \< 12 month
• Insulin dependent Diabetes
• Decompensated heart failure (NYHA \> 2)
• Myocardial infarction within the last 6 months, symptomatic atrial fibrillation
• Severe acute infection
• Pregnancy
• Pancreatic insufficiency

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

Rehaklinik Am Kurpark

Bad Kissingen, Baden-Wurttemberg, 97688, Germany

Location

Related Publications (12)

• Woolf 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 BACKGROUND

• Klement 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

  BACKGROUND

• Fine 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 BACKGROUND

• Kossoff 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 BACKGROUND

• Klement 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 BACKGROUND

• Seyfried 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 BACKGROUND

• Schmidt 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 BACKGROUND

• 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.

  PMID: 20934305 BACKGROUND

• Masko EM, Thomas JA 2nd, Antonelli JA, Lloyd JC, Phillips TE, Poulton SH, Dewhirst MW, Pizzo SV, Freedland SJ. Low-carbohydrate diets and prostate cancer: how low is "low enough"? Cancer Prev Res (Phila). 2010 Sep;3(9):1124-31. doi: 10.1158/1940-6207.CAPR-10-0071. Epub 2010 Aug 17.

  PMID: 20716631 BACKGROUND

• Seyfried BT, Kiebish M, Marsh J, Mukherjee P. Targeting energy metabolism in brain cancer through calorie restriction and the ketogenic diet. J Cancer Res Ther. 2009 Sep;5 Suppl 1:S7-15. doi: 10.4103/0973-1482.55134.

  PMID: 20009300 BACKGROUND

• Chu-Shore CJ, Thiele EA. Tumor growth in patients with tuberous sclerosis complex on the ketogenic diet. Brain Dev. 2010 Apr;32(4):318-22. doi: 10.1016/j.braindev.2009.04.009. Epub 2009 May 13.

  PMID: 19443154 BACKGROUND

• Kossoff EH, Turner Z, Bergey GK. Home-guided use of the ketogenic diet in a patient for more than 20 years. Pediatr Neurol. 2007 Jun;36(6):424-5. doi: 10.1016/j.pediatrneurol.2007.01.013.

  PMID: 17560509 BACKGROUND

Related Links

• Hompage of the clinic in which the study is about to be accomplished.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marc Sütterlin, MD, Prof.

  Department of Obstetrics and Gynecology, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany

  STUDY CHAIR

• Monika Reuss-Borst, MD, Prof.

  Rehaklinik Am Kurpark, Bad Kissingen, Germany

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 20, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 26, 2016

Record last verified: 2016-02

Locations

DE (1)