Journal of Cancer Prevention

eISSN 2288-3657
pISSN 2288-3649

Clinical trials (including prospective cohort study) using KD in cancer patients

Author (journal and year) No. of subjects and characteristics Cancer type KD intervention (duration and regimen) Adherence Outcome measures and results Side effect
Fearon et al.11 (Am J Clin Nutr 1988) Total n = 5Cachectic patients (mean age, 61 yr)Country: Italy 2 Gastric cancer2 Lung cancer1 Ovarian cancer 6 days balanced enteral formula (BD) → 7 days KD enteral formula (KD)BD: kcal: 44 kcal/kg/d prot: 1.5 g/kg/d (55% carbohydrate, 31% fat)KD: kcal: 44 kcal/kg/d prot: 1.5 g/kg/d (whey) 4.4 mmol argninine/kg/d  (70% of calorie as MCT) 100% BD No change of body weight No change of nitrogen balance No change of prot turnoverKD Increased body weight No change of nitrogen balance No change of prot turnover No GI upset
Rossi-Fanelli et al.12 (Clin Nutr 1991) Total n = 27TNM stagedArm A: n = 9 (median age, 61 yr)Arm B: n = 9 (median age, 70 yr)Arm C: n = 9 (median age, 67 yr)Country: Italy 9 Oesophagus9 Stomach9 Colorectal 14 days interventionIso-kaloric regimenArm A: parenteral nutrition 100% dextrose 0.24 g/kg/d amino-acid Vitamin mineralsArm B: parenteral nutrition 80% as fat, 20% as dextrose 0.24 g/kg/d amino-acid Vitamin mineralsArm C: oral diet 100% No group differences were found in S-phase fraction of cell cycle Total lymphocyte counts Blood glucose Triglycerides Body weight Mid-arm circumferences Serum albumin Pre-albumin Transferrin Retinol-binding prot Not mentioned
Breitkreutz et al.13 (Wien Klin Wochenschr 2005) Total n = 23Moderately malnourished cancer patientsGroup A: n = 11 (mean age, 60.6 yr)Group B: n = 12 (mean age, 58.8 yr)Country: Germany 12 Colorectal11 GastricAll metastases Group A 8 weeks of 35 kcal/kg/d, 1.1 g prot/kg/d (normal meals) Nutritional counseling every 14 daysGroup B 8 weeks of 20 kcal/kg/d, 1.1 g prot/kg/d (fat-enriched liquid diet + normal meals) Nutritional counseling every 14 days 100% Group A Average intake 1,556 ± 497 kcal Progressive weight loss Progressive loss of FFM Decrease in serum albumin No change TLC No change of QOLGroup B Average intake 1,865 ± 317 kcal Increased body weight Progressive increase of FFM No change in serum albumin Significant decrease of TLC No change of QOL Not mentioned
Schmidt et al.14 (Nutr Metab (Lond) 2011) Total n = 16Metastatic tumors (mean age, 50.4 yr)Country: Germany 3 Ovarian cancer1 Breast cancer1 Osteosarcoma5 Gastrointestinal cancer2 Thyroid cancer1 Endometrial1 Lung cancer1 Granulosa cell tumor1 Parotis carcinoma 3 months of low CHO diet (KD)

- CHO limitation to 70 g/d, 20 g/meal

- 2 liquid meals (21 g fat, 5 g CHO, 14 g prot)/meal

31% (2 died, 9 dropped out) KD 3 patients reached ketosis No change: Global health status  Functional score  Blood glucose, TG  creatinine, Albumin Increase: appetite loss, constipation  Diarrhea (at 4 wk) Increase: fatigue, pain Decrease: insomnia No diet related adverse events
Fine et al.15 (Nutrition 2012) Total n = 109Incurable, advanced cancer (mean age, 62.9 yr)Country: USA 2 Breast cancer3 Colorectal1 Ovary1 Fallopian tube2 Lung1 Esophagus 26–28 days KD intervention

- < 5% of kcal as CHO

- Increase fat and prot encouraged

100% KD Increased weight loss (−3.0 kg) Energy deficit (−35%) No change of serum glucose Increased dietary ketosis Inverse relationship of insulin vs. β-hydroxybutyrate No unsafe adverse effectsExcept constipation, leg cramps, reversible fatigue
Schroeder et al.16 (Nutr Cancer 2013) Total n = 12Head and neck cancer (mean age, 64 yr)Country: Germany 2 Larynx3 Oral cavity2 Hypopharynx3 OropharynxUnknown primary 5 days KD interventionMicrodialysis 100% KD Increase of urea in tumor tissues No change in plasma glucose Decrease in lactate concentration in tumor tissues Decrease in lactate/pyruvate ratio Not mentioned
Rieger et al.17 (Int J Oncol 2014) Total n = 20Patient from ERGO trial (mean age, 57 yr)Country: Germany Recurrent malignant glioma 36 days interventionKD diet: ketogenic ratio, 3.41 : 1

- CHO limitation to less than 60 g/d

- No calorie restriction

- 500 mL yoghurt + plant oil

85% KD Increased weight loss No change in blood glucose, HbA1c, lipid profiles Leukcytopenia in 2 patients Overall survival 32 weeks Few reports on diarrhea, constipation but no major concern or toxicity
Jansen and Walach18 (Oncol Lett 2016) Total n = 78Prospective cohort study (mean age, 68 yr)Country: Germany 18 Breast16 Prostate9 Colon5 Lung5 Otoharyngeal25 Other 10 mo–2 yr65 not ketogenic6 partially ketogenic7 fully ketogenic Not mentioned KD Reduction of TKTL1 (novel marker associated with tumor progression) 3 out of 7 patients had improvement 1 had full remission Not mentioned
Klement and Sweeney19 (BMC Res Notes 2016) Total n = 6 (mean age, 60.3 yr)Country: Germany 1 Breast1 Prostate3 Rectum1 Lung during RT 32–73 dKD with weekly counseling

- CHO limitation to 50 g/d

- Encourage to consume olive oil, coconut oil, butter, fatty fish, cheese, meat

Not mentioned KD

- Decreased BW in 2 patients

- Decreased fat mass in 2 patients

- No change in hydration status

- Decreased phase angle

- Increased ketone body

Not mentioned
Tan-Shalaby et al.20 (Nutr Metab (Lond) 2016) Total n = 17Advanced cancer pts not on hemotherapy (mean age, 65 yr)Country: USA 6 Gastrointestinal2 Lung3 Skin cancer1 Prostate1 Thyroid2 Brain cancer1 Head/neck1 Renal 16 weeks (checked every 4 wk)KD

- CHO limitation to 20–40 g/d (no restriction of cal, prot, fat)

64.7% (6 for 8 wk, 4 for 16 wk, 3 beyond 16 wk) KD

- 13% wt loss at week 16

No changes in glucose, creatinine, SBP/DBP, lipid profile, WBC count, uric acid, albumin, ALT

Slight improvement of EORTC QLQ-30

8 Weight loss7 Hyperuicemia2 Hyperlipidemia2 Pedal edema2 Anemia2 Halitosis2 Pruritus2 Hypoglycemia2 Hyperkalemia2 Hypokalemia2 Hypomagnesemia2 Flu-like symptom

KD, ketogenic diet; BD, balanced diet; MCT, medium chain triglyceride; prot, protein; GI, gastrointestinal; FFM, fat free mass; TLC, total lymphocyte count; QOL, quality of life; CHO, carbohydrate; TG, total cholesterol; RT, radiation therapy; BW, body weight; wt, weight; SBP, systolic blood pressure; DBP, diastolic blood pressure; WBC, white blood cell; ALT, alanine aminotransferase; EORTC QLQ-30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30.

Journal of Cancer Prevention 2017;22:127~134
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