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Table 1 Ketogenic diet results table

From: Dietary restriction during the treatment of cancer: results of a systematic scoping review

Reference (author, year, country) Design Population (No. of participants, age, site/lesion type) Intervention (DR intervention, corresponding cancer treatment) Feasibility Tolerance Treatment effect
Cohen, 2016, USA [21] Feasibility RCT 73 randomised, 45 analysed (25 in IG, 20 in CG)
Mean age 60.2y (range 31-79y)
Recurrent ovarian cancer
KD: 5% CHO, 25% protein, 70% fat over 12 wks.
Usual care (24% received concurrent chemotherapy)
62% retention
80% adherence (defined as 0.5 mmol/L urinary ketone conc.)
↔ lean body mass between groups
↓total body fat (kg) (32.7 ± 3.1 vs 41.2 ± 4.4) android fat (kg) (2.8 ± 0.4 vs 3.6 ± 0.5), and visceral fat (g) (975 ± 150.9 vs 1024 ± 175.6) (p < 0.05) in IG
↓insulin (μU/mL) in IG (6.7 ± 0.9 vs 12.1 ± 1.5, p < 0.01)
↔ glucose
↓C-peptide in IG (2.0 ± 0.3 vs 3.0 ± 0.3, P < 0.01)
↔ IGF-I or IGFBP-1
↑ physical component scores in IG (45 vs 40 p = 0.04)
↔ mental component score
↑cravings for salt (p = 0.03), and
↓cravings for starchy foods (p = 0.03) and fast food fats (p = 0.04) in IG
↔ cravings for high-fat foods or sweets
Anderson 2016, USA [22] Phase 1 trial with single assignment 9
Age NR
Stage 3-4b head and neck squamous cell carcinoma
4:1* KD fed by PEG followed by oral intake for 5 wks.
Concurrent platinum chemo-radiotherapy
33% retention
Ppts who discontinued completed a median of 6 days (range 0–8 days) on KD
Trial terminated early (intended sample size 14)
6 discontinued: additional stress (n = 1), grade 2/3 nausea (n = 3), grade 3 fatigue (n = 1), grade 4 hyperuricemia (n = 1)
2 SAEs: hyperuricemia, pancreatitis
4 SAEs: parotiditis, nausea, vomiting, neutropenic fever
↑Ketones in compliant ppts (median 24 days, range 19–25 days)
↑BHB levels in compliant ppts (median 5 wks, range 4-5wks)
↔ lipid panel test at 3wks
↑ Serum oxidative stress markers with increasing days on KD
Renda 2015 and Dardis, 2017, USA [23] Phase 1/2 trial with single assignment 14
Mean age 45y (range 37-63y)
Brain cancer
4:1 KD* for 8 wks during concurrent radiation and chemotherapy, followed by a 1:1 diet during adjuvant temozolomide chemotherapy 47% recruitment
14% stopped due to tolerability
Trial terminated early (intended sample size 40)
No weight loss > 10% of baseline (NB - only reported in preliminary results from 6 ppts) 29% reported nausea
Rieger 2010 and Rieger, [24], Germany [25] Pilot study with single assignment 20
Mean age 55y (range 30-72y)
Brain cancer
KD: < 60 g/day CHO consumed with 500 ml highly fermented yoghurt drinks and 2 plant oils daily.
Followed diet for 6–8 wks alone and for a further 6–8 wks either alone or during salvage chemotherapy (n = 8)
15% discontinued after 2–3 wks (diet negatively affecting QoL) ↓ body weight (− 2.2%) at 6–8 wks
No SAEs attributable to diet
No grade 3 AEs
12 out of 13 evaluable ppts achieved ketosis (73% of urine samples had detectable ketosis)
↔ blood glucose and HbA1c at 6–8 wks
Zahra, 2017, USA [26] Phase 1 trial with single assignment 9
Age range 51-83y
Non small cell lung cancer (n = 7)
Pancreatic cancer (n = 2)
4:1 KD: 90% fat, 8% protein,2% CHO (KetoCal powder + food provided). KD 2 days prior to chemo-radiotherapy until end of treatment (6wks for lung and 5wks for pancreatic) 71% withdrawal in lung cancer ppts: Difficulty complying (n = 4), grade 4 hyperuricemia (n = 1)
50% withdrawal in pancreatic cancer ppts: Grade 3 dehydration (n = 1)
Average time on diet: 16.9 days (0–42) for lung and 21 days (8–34) for pancreatic cancer ppts
↓body weight in lung (−6%) and pancreatic (−9.75%) cancer ppts Grade 3/4 nausea (n = 1), dehydration (n = 1), esophagitis (n = 1)
Ketosis achieved in 89%
Ketosis maintained in 33%
↔ blood glucose
↑ median plasma protein carbonyl content (nmol/mg) from pre- to post- diet (1.0 vs ≈ 1.4, p < 0.05)
Artzi, 2017, Israel [27] Non randomised trial 9 (5 in IG, 4 in CG)
IG: mean age 51y (range 37–69y)
CG: mean age 46y (range 27–64y)
Brain cancer
4:1 KD using KetoCal® formula for 2–31 months
Bevacizumab, temozolomide or rindopepimut
40% adherence (self-report and urine ketones; ppt considered adherent when ketone level was > 2 urine ketosis) 80% tolerance (tolerability criteria not defined) Evidence of ketone bodies within the brain found in 67% of cases and 0% of controls
Champ, 2014, USA [28] Retrospective case control study 53 (6 cases, 47 controls)
Mean age 54y (range 34-62y)
Grade 3–4 glioblastoma
“Patient driven KD” – CHO levels below 50 g/day or 30 g/day if ketosis not reached
Chemo-radiotherapy or adjuvant chemotherapy
NR Grade 1 constipation (n = 2)
Grade 2 fatigue (n = 1)
No grade 3 toxicity
Confirmed ketosis in all cases
↓mean glucose in cases from 142.5 mg/dl (range 82–181 mg/dl) to 84 mg/dl (range 76–93 mg/dl) (p = 0.02)
Klement, 2016, Germany [29] Case series 6
Mean age 60y (range 40-74y)
Breast (n = 1), prostate (n = 1), rectal (n = 3) and lung (n = 1) cancer
KD: 80% fat and < 50 g/day CHO during treatment (mean 48.2 days, range 32–73 days)
Radiotherapy or chemo-radiotherapy
100% adherence rate to < 50 g/day CHO consumption
Average energy from fat 73%
Low BHB and high glucose in some ppts self-reporting as adherent
KD more satiating than previous diet (self report)
General subjective feeling on diet rated as “good”
100% reported they would continue with a low CHO/KD after RT
↓ weight (kg/wk) in 33%
↓FM in 50%
↔ absolute FFM
↑ FFM relative to body weight in 50%
↑ (worsening) symptom scores for fatigue, nausea/vomiting, appetite loss, diarrhoea
↑ in BHB
↔ glucose
↔ global health status and total functional scores
Attar [30] and 2016, USA [31] Retrospective review 13
Age range 23-72y (mean NR)
Recurrent brain cancer
Modified Atkins Diet: up to 60 g/day carbohydrate (2–5% total calories) from 1 to 21 months
9 on chemotherapy
85% adherence (range 1–21 months) 2 discontinued: weight loss (n = 1), inconvenience (n = 1)
1 SAE: renal calculus at 11 months
100% achieved ketosis
Randazzo, 2015, USA [32] Retrospective data registry review 596 (81 cases, 515 controls)
Mean age 49.6y (range NR)
Brain cancer
Self-administered “special diets” including KD, Low CHO, vegetarian/vegan
Usual care
NR NR NR – data not stratified by diet type
  1. *4:1 KD: A ketogenic diet consisting of 80% energy intake from fat
  2. ↑ = increase/higher
  3. ↓ = reduction/lower
  4. ↔ = no change/no difference
  5. ≈ = approximate
  6. Where absolute figures were provided, %s have been calculated to aid comparison
  7. Abbreviations: AEs Adverse Events, BHB Beta-hydroxybutyrate, CG Control Group, CHO Carbohydrate, DLT Dose Limiting Toxicities, DR Dietary Restriction, FM Fat Mass, FFM Fat Free Mass, HbA1c Glycated Haemoglobin, HPD highest posterior density interval, IG Intervention Group, IGF Insulin-like Growth Factor, IGFBP Insulin-like Growth Factor Binding Protein, NR Not Reported, PEG Percutaneous Endoscopic Gastrostomy, Ppt Participant, QoL Quality of Life, RCT Randomised Controlled Trial, SAEs Serious Adverse Events
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