Abstract
Purpose
Interest in ketogenic diets (KDs) as complementary nutritional treatments for cancer patients is rising, although some skepticism about their safety exists. We, therefore, studied the effects of KDs on quality of life and blood parameters in rectal cancer patients undergoing radio-chemotherapy.
Methods
EORTC-QLQ30 questionnaire scores and different metabolic and hormonal blood parameters were obtained prior to, in the middle of and at the end of radiotherapy within the KETOCOMP study (ClinicalTrials.gov Identifier: NCT02516501). A total of 18 patients consuming a KD were compared to 23 patients consuming their standard diet (SD). Baseline-end differences were measured using Wilcoxon tests, and repeated measures analysis was performed using linear mixed effects models.
Results
Eighty-nine percent of patients on the KD reported subjectively feeling good or very good, but roughly half of them rated the daily routine implementation as difficult. Only the SD group experienced significant declines in physical and role functioning, while the KD group improved in role (p = 0.045), emotional (p = 0.018) and social functioning (p = 0.009).Urinary frequency, buttock pain and fatigue significantly increased in the SD group, but to a much lesser extent in the KD group. Several biomarkers of metabolic health (gamma-glutamyl-transpeptidase, triglyceride-glucose index, HDL cholesterol/triglyceride ratio, and free T3) improved in the KD, but not the SD group.
Conclusions
Despite being perceived as difficult to implement by ≈50% of patients, KDs are feasible as complementary therapies alongside radio-chemotherapy and associated with subjective well-being. The hypothesis that they exert beneficial effects on quality of life and metabolic health in rectal cancer patients is supported by our data.
Trial registration
ClinicalTrials.gov identifier NCT02516501, registered Aug 6th 2015.
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Data availability statement
All data used in this analysis are available from the corresponding author upon reasonable request.
Notes
This threshold was chosen based on the conversion between p values and minimum Bayes factors [52]. Bayes factors (or likelihood ratios in case of simple hypotheses) measure the strength of evidence between two competing hypotheses [70]. In exploratory analyses, a p value of 0.01 corresponds to a minimum Bayes factor of 1/6.5, providing moderate to strong evidence against the null hypothesis [52].
according to our definition of significance (p < 0.01).
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Acknowledgements
We thank Petra Koebrunner, Kelly Krage and Nanina Brehm for helping us to collect the data.
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RJK: conceptualization, data curation, formal analysis, supervision, and writing—original draft. DM: resources and writing—review and editing. SK: resources and writing—review and editing. RAS: conceptualization, supervision, resources, and writing—review and editing.
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RJK has received an honorarium from the company vitaflo for giving a talk about the objectives and preliminary results of the KETOCOMP study. RJK and RAS are occasionally on a ketogenic diet. No other potential conflicts of interest associated with this research exist or any of the authors.
Ethical approval
This study has been approved by the ethics committee of the Bavarian Medical Association (Landesärztekammer Bayern) under reference number 15025 and registered on 6 Aug 2015 under ClinicalTrials.gov identifier NCT02516501 (URL: https://clinicaltrials.gov/ct2/show/NCT02516501).
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All study subjects gave their written informed consent to participate in the study with the option to withdraw at any time.
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Klement, R.J., Meyer, D., Kanzler, S. et al. Ketogenic diets consumed during radio-chemotherapy have beneficial effects on quality of life and metabolic health in patients with rectal cancer. Eur J Nutr 61, 69–84 (2022). https://doi.org/10.1007/s00394-021-02615-y
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DOI: https://doi.org/10.1007/s00394-021-02615-y