Ketogenic diets as an adjuvant therapy in glioblastoma (the KEATING trial)

Not Applicable

Completed

• Conditions: Cancer; Glioblastoma

• Registration Number: ISRCTN71665562
• Lead Sponsor: niversity of Liverpool

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29209515 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32036576 (added 18/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-13
• Study Completion: 2019-03-05
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

From 31/08/2017:
1. Age 16 years and over
2. Patient at The Walton Centre NHS Foundation Trust
3. Performance status =2 (S?rensen et al., 1993)
4. Confirmed histological diagnosis of GB (WHO grade IV)
5. Undergone surgical resection or biopsy within the last 4 months and will go onto receive/ is currently receiving/ has received oncological treatment

Before 31/08/2017:
1. Age 16 years and over
2. Patient at The Walton Centre NHS Foundation Trust
3. Performance status =2 (S?rensen et al., 1993)
4. Confirmed histological diagnosis of GB (WHO grade IV)
5. Undergone surgical resection and will go onto receive chemoradiotherapy

Exclusion Criteria

From 31/08/2017:
1. Having prior use of a ketogenic diet
2. Kidney dysfunction
3. Liver dysfunction
4. Gall bladder dysfunction
5. Metabolic disorder
6. Eating disorder
7. Diabetes (requiring medication)
8. Body mass index (BMI) =18.5kg/m2
9. Weight loss medications
10. Currently pregnant or breastfeeding
11. Performance status =3

Before 31/08/2017:
1. Having prior use of a ketogenic diet
2. Kidney dysfunction
3. Liver dysfunction
4. Gall bladder dysfunction
5. Metabolic disorder
6. Eating disorder
7. Diabetes (requiring medication)
8. Body mass index (BMI) =18.5kg/m2
9. Weight loss medications
10. Pregnancy
11. Performance status =3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Retention rate is measured by recording:<br> 1. The number of patients who start randomized treatment as a proportion of the number randomized a 12 weeks<br> 2. The number of patients who complete 12 months as a proportion of the number randomized<br> 3. The time to dietary discontinuation<br> 4. A description of barriers and facilitators to data collection and participant retention<br>