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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
Timepoint [1] 0 0
9 weeks
Secondary outcome [1] 0 0
Mean daily blood glucose-to-ketone ratio during 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
Timepoint [2] 0 0
33 weeks
Secondary outcome [3] 0 0
Change in weight
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)
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
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
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
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
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
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
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
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
1/12/2024
Actual
Sample size
Target
22
Accrual to date
Final
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
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Wellington Hospital
Address [1] 0 0
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
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Upon reasonable request for research purposes only, de-identified patient data may be shared with other investigators.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Starting immediately upon publication.
Available to whom?
Upon reasonable request for research purposes.
Available for what types of analyses?
How or where can data be obtained?


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