None listed
Conditions
Brief summary
Chemotherapy and radiotherapy for the most aggressive form of primary brain tumour, glioblastoma multiforme (GBM), offers only modest disease control, with half of all patients having disease progression before finishing their 8 month treatment programme, and about 3/4 dying within 2 years. Strategies to improve survival have largely been ineffective. These tumours are almost completely reliant on glucose for fuel, and laboratory studies have reported that radiation treatment for GBM is much more effective when mice are fed a diet extremely low in carbohydrates. Such a diet is called “Ketogenic”, because the body generates ketones (the smell is like green apples) as an alternative fuel source for the brain and other organs. Such diets have been used for decades to help control seizures in children with epilepsy. There are case reports in the literature of patients with GBM who use these diets while on chemotherapy and radiation without apparent ill effects, and their outcomes appear encouraging. However a more careful analysis of patients trying these diets is important to know how well most patients tolerate such a diet, whether it is safe during treatment, whether they enjoy their food and maintain a good nutritional status and whether there appears to be an improved outcome compared to patients treated while having their usual diet. We plan to conduct a pilot study in 20 patients having chemotherapy and radiotherapy for GBM to answer these questions.
Interventions
Ketogenic diet (<30g carbohydrate per day) starting one week prior to standard treatment and continuing until all planned treatment has been completed. Patients will attend a 1 hour session with a dietitian at baseline to go through the dietary guidelines.
Standard treatment consists of 60 Gy radiation in 30 fractions over 6 weeks with concurrent daily oral temozolomide 75 mg/m2 (for no longer than 49 days); four weeks after completion of radiation patients will start six cycles of adjuvant te
Ketogenic diet (<30g carbohydrate per day) starting one week prior to standard treatment and continuing until all planned treatment has been completed. Patients will attend a 1 hour session with a dietitian at baseline to go through the dietary guidelines. Standard treatment consists of 60 Gy radiation in 30 fractions over 6 weeks with concurrent daily oral temozolomide 75 mg/m2 (for no longer than 49 days); four weeks after completion of radiation patients will start six cycles of adjuvant temozolomide, taken orally daily days 1-5 of the 28-day cycle; the daily dose is 150 mg/m2 in the first adjuvant cycle then, if well-tolerated haematologically, 200 mg/m2 for remaining cycles, as tolerated.
Sponsors
Waikato District Health Board
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with biopsy-proven glioblastoma multiforme who are considered suitable for standard chemoradiation (including adequate performance status and bone marrow, hepatic and liver function). * Patients must be mentally competent to understand the requirements of the diet and believe that they, with the support of their carers, are capable of achieving them. * Patients have given written informed consent
Exclusion criteria
* Diabetic patients who are at risk of hypoglycaemic events (such as those on insulin or sulphonylureas) * Current pregnancy or breast-feeding
Outcome results
None listed