Table 5.
Planned/ongoing trials registered in clinicaltrials.gov and ISRCTN databases
| Trial Registration | Trial design | Participants (target recruitment number and type of cancer) | Primary outcomes | Planned start and end dates |
|---|---|---|---|---|
| Ketogenic Diets | ||||
| NCT03285152 | Feasibility RCT | 30 Endometrial | No. of patients that complete the study | Aug 2017- Aug 2019 |
| NCT02983942 | Pilot RCT | 50 Primary Central Nervous System Lymphoma | No. and incidence of treatment related AEs | Jan 2017 – Dec 2019 |
| SRCTN71665562 | Pilot RCT | 12 Glioblastoma | Retention rate | Jul 2016 – June 2019 |
| NCT02302235 | RCT | 42 Glioblastoma |
1. Survival time 2. Time to progression (MRI assessed) 3. Incidence of AEs |
Feb 2014 – Dec 2018 |
| NCT01754350 | RCT | 50 Glioblastoma | Progression-free-survival rates 6 months after reirradiation | May 2013 – June 2018 |
| NCT03278249 | Feasibility trial (single arm) | 30 Glioblastoma | Ketosis (measured by serum BHB) | Sep 2017 – Jan 2021 |
| NCT01865162 | Pilot trial (single arm) | 6 Glioblastoma | Safety evaluation | Jan 2013 – Jan 2019 |
| NCT01535911 | Pilot trial (single arm) | 16 Glioblastoma | Brain tumour size response (MRI assessed) | Apr 2012 – June 2019 |
| NCT03451799 | Clinical trial (single arm) | Glioblastoma | Safety assessed by weight loss and AEs | Apr 2018 – Sep 2020 |
| NCT02964806 | Crossover trial | 30 Pancreaticobiliary Cancer | Diet intake rate | Nov 2016 – Oct 2017 |
| NCT02939378 | Non-randomised trial (2 arms) | 60 Glioblastoma | No. of participants with AEs | Oct 2016 – Dec 2018 |
| NCT03535701 | Non-randomised trial (2 arms) | 15 Breast |
1. Adherence 2. Change in psychosocial measures 3. Change in physiologic outcomes |
Oct 2017 – Aug 2019 |
| NCT03194516 | Observational | 12 Prostate | Weight loss at 8 weeks | June 2017 – May 2021 |
| Short-term Fast | ||||
| SRCTN17994717 | Feasibility RCT | 30 Colorectal |
Adherence, recruitment, retention and data completion rates Acceptability and tolerability |
Oct 2017 – Apr 2021 |
| Fasting Mimicking Diets | ||||
| NCT02126449 | RCT | 250 Breast |
1. Rate of grade 3/4 toxicity 2. Rate of pCR |
Feb 2014 – Dec 2019 |
| NCT03700437 | RCT | 40 Lung | Effect of diet on circulating tumour cells | Oct 2018 – Dec 2020 |
| NCT03340935 | Feasibility trial (single arm) | 85 Any cancer | AEs | Feb 2017 – June 2018 |
| NCT03595540 | Pilot trial (single arm) | 60 Breast and colorectal |
1. % diet consumed 2. Diet related AEs |
Nov 2017 – Sep 2020 |
| NCT03454282 | Clinical trial (single arm) | 100 Breast and melanoma | Change in peripheral blood mononuclear cell | May 2018 – Dec 2020 |
| Intermittent Fasts | ||||
| NCT03162289 | RCT | 150 Breast | Change in FACT-G Quality of Life score | May 2017 – May 2022 |
| NCT02710721 | RCT | 60 Prostate | Change in FACT-P Quality of Life score | April 2016 – Dec 2019 |
| Ketogenic Diet combined with Short-Term Fast | ||||
| NCT02286167 | Clinical trial (single arm) | 25 Glioblastoma Multiforme | Dietary adherence rates | Nov 2014 – April 2019 |
Abbreviations: AE Adverse Events, BHB Beta-hydroxybutyrate, MRI Magnetic Resonance Imaging, pCR Pathological Complete Response, RCT Randomised Controlled Trial