Register a trial

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04730869




Registration number
NCT04730869
Ethics application status
Date submitted
22/12/2020
Date registered
29/01/2021

Titles & IDs
Public title
Metabolic Therapy Program In Conjunction With Standard Treatment For Glioblastoma
Scientific title
Feasibility, Safety, and Efficacy of a Metabolic Therapy Program in Conjunction With Standard Treatment for Glioblastoma
Secondary ID [1] 0 0
U1111-1262-0203
Secondary ID [2] 0 0
RD020132
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Standard Treatment Plus Metabolic Therapy Program

Experimental: Standard treatment in conjunction with MTP - Standard:

* Concurrent chemoradiation - Radiation (60-Gy in 30 fractions over 6 weeks) with daily oral temozolomide.
* Adjuvant chemotherapy - Daily oral temozolomide (5 days per 4-week cycle, starting 4 weeks after completion of chemoradiation, with at least 6 cycles intended).

MTP:

- Two 5-day fasts (allowing water, salt, tea, coffee, and a magnesium supplement) during chemoradiation followed by a 5-day fast during each adjuvant chemotherapy cycle, with a time-restricted modified ketogenic diet (one or two 1-hour eating windows per day, allowing oils, meats, vegetables, nuts, seeds, limited berries, and a multivitamin) between fasts.


Other interventions: Standard Treatment Plus Metabolic Therapy Program
See description under "Arms."
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean daily blood glucose-to-ketone ratio during chemoradiation
Assessment method [1] 0 0
Proportion of patients able to sustain functional ketosis (defined as a mean daily blood glucose-to-ketone ratio of =6) during chemoradiation (defined as the beginning of the first fast through to 3 weeks following completion of chemoradiation)
Timepoint [1] 0 0
9 weeks
Secondary outcome [1] 0 0
Mean daily blood glucose-to-ketone ratio during adjuvant chemotherapy
Assessment method [1] 0 0
Proportion of patients able to sustain functional ketosis during adjuvant chemotherapy (defined as the beginning of the first adjuvant chemotherapy fast through to completion of adjuvant chemotherapy)
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Mean daily blood glucose-to-ketone ratio during the MTP, calculated separately on fasting and ketogenic diet days
Assessment method [2] 0 0
Proportion of patients able to sustain functional ketosis during the MTP (defined as the beginning of chemoradiation through to the end of adjuvant chemotherapy), calculated separately each fasting and ketogenic diet phase
Timepoint [2] 0 0
33 weeks
Secondary outcome [3] 0 0
Change in weight
Assessment method [3] 0 0
Weight (kg)
Timepoint [3] 0 0
33 weeks
Secondary outcome [4] 0 0
Safety as measured by National Cancer Institute Common Terminology Criteria for Adverse Events (version 4)
Assessment method [4] 0 0
Number of adverse events (of any grade)
Timepoint [4] 0 0
After each week (7 days) during chemoradiation, then after cycle 1 (28 days) of adjuvant chemotherapy, then after every 2 cycles (56 days) of adjuvant chemotherapy
Secondary outcome [5] 0 0
Change in performance status as measured by Eastern Cooperative Oncology Group Performance Status scale
Assessment method [5] 0 0
Eastern Cooperative Oncology Group Performance Status scale (scores range from 0 to 5, with higher scores indicating lower performance status)
Timepoint [5] 0 0
After each week (7 days) during chemoradiation, then after cycle 1 (28 days) of adjuvant chemotherapy, then after every 2 cycles (56 days) of adjuvant chemotherapy
Secondary outcome [6] 0 0
Change in leisure/exercise activity as measured by Godin Leisure-Time Exercise questionnaire
Assessment method [6] 0 0
Godin Leisure-Time Exercise questionnaire (scores range from 0 to no maximum, with higher scores indicating higher leisure/exercise activity)
Timepoint [6] 0 0
After each week (7 days) during chemoradiation, then after cycle 1 (28 days) of adjuvant chemotherapy, then after every 2 cycles (56 days) of adjuvant chemotherapy
Secondary outcome [7] 0 0
Change in quality of life as measured by Functional Assessment of Cancer Therapy - Brain questionnaire
Assessment method [7] 0 0
Functional Assessment of Cancer Therapy - Brain questionnaire (scores range from 0 to 200, with higher scores indicating higher quality of life)
Timepoint [7] 0 0
After each week (7 days) during chemoradiation, then after cycle 1 (28 days) of adjuvant chemotherapy, then after every 2 cycles (56 days) of adjuvant chemotherapy
Secondary outcome [8] 0 0
Progression-free survival
Assessment method [8] 0 0
Progression-free survival
Timepoint [8] 0 0
From date of biopsy-confirmed diagnosis to date of first documented progression, whichever came first, up to 33 weeks
Secondary outcome [9] 0 0
Overall survival
Assessment method [9] 0 0
Overall survival
Timepoint [9] 0 0
From date of biopsy-confirmed diagnosis to date of death from any cause, whichever came first, up to 33 weeks

Eligibility
Key inclusion criteria
1. Age 18 years or greater.
2. Newly-diagnosed histologically-confirmed GBM.
3. ECOG Performance Status 0-2.
4. Planned for 6 weeks of standard chemoradiation for GBM.
5. If receiving dexamethasone, the dose must be = 4 mg daily (and not increasing) upon commencement of the MTP.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ineligible for standard treatment for GBM due to poor performance status, co-morbidities, or inability to give informed consent.
2. Type 1 diabetes.
3. A medical or psychiatric disorder that, in the opinion of the investigators, would make it unlikely that the patient could adhere to the MTP.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/03/2026
Actual
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Other
Name
Waikato Hospital
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Wellington Hospital
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew CL Phillips, FRACP
Address 0 0
Waikato Hospital
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Matthew CL Phillips, FRACP
Address 0 0
Country 0 0
Phone 0 0
+64274057415
Email 0 0
Matthew.Phillips@waikatodhb.health.nz
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04730869