Glioblastoma MultiformePhase 1/2KGDinrGBMNCT02939378
Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
A Phase 1/2 study testing Ketogenic diet and Standard diet in people with Glioblastoma Multiforme, run by Song Lin at 1 site in China.
Trial summary
Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro. Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Ketogenic diet and Standard diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- Karnovsky Performance Score of 60 or more.
- histologically confirmed glioblastoma multiforme, grade 4
- Ability and willingness to signed informed consent form.
- Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy.
- normal function of liver and kidney
Who cannot join
- Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
- History of uncontrolled hyperlipidemia or hyperglycemia.
- History of human immunodeficiency virus, or hepatitis C
- Pregnancy or breastfeeding
- Inability or unwillingness of subject to give written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100005
Song Lin, M.D.,, +8601067096509, linsong2005@126.com
Xiaohui Ren, M.D.,, +8601067096509, xiaohuiren@aliyun.com
About this study
Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro.
Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma.
Read the detailed description
Diet change by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and inhibit tumor growth.
In a pilot of recurrent glioblastoma, ketogenic diet adjuvant salvage chemotherapy was given as interventional group and standard diet adjuvant salvage chemotherapy was given as control group.
The study examines whether a ketogenic diet adjunctive to salvage chemotherapy can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Ketogenic diet, Standard diet
- Keywords
- ketogenic diet, recurrent glioblastoma, chemotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietDietary supplement
Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
Standard dietDietary supplement
Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
| Study group | Role | What they receive |
|---|---|---|
| ketogenic diet group | Experimental | Ketogenic diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were kept more than 2mmol/L during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded. Receives: Dietary Supplement: Ketogenic diet |
| Standard diet group | Other | Standard diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were recorded during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded. Receives: Dietary Supplement: Standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Effects
Number of participants with treatment-emergent adverse effects while on ketogenic diet.
Measured: one year
Secondary outcomes (4)
The Chemosensitivity of Tumor
MRI(Magnetic Resonance Imaging) will be used to measure changes in brain tumor size (cm^2).
Measured: one year
Overall Survival
Participants were followed until reported death
Measured: one year
Ketosis
Urine and blood ketosis (mmol/L) were measured
Measured: one year
Quality of Life
quality of life measured by the Karnofsky Performance Scale
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Song Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Song Lin, Beijing Tiantan Hospital
- Investigators
- Song Lin, M.D.,, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939378
- Sponsor's protocol ID
- B0009
- Acronym
- KGDinrGBM
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
- ClinicalTrials.gov ID
- NCT02939378
- Acronym / sponsor ID
- KGDinrGBM / B0009
- Conditions
- Glioblastoma Multiforme
- Keywords
- ketogenic diet, recurrent glioblastoma, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Song LinUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro.
Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma.
Detailed description
Diet change by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and inhibit tumor growth.
In a pilot of recurrent glioblastoma, ketogenic diet adjuvant salvage chemotherapy was given as interventional group and standard diet adjuvant salvage chemotherapy was given as control group.
The study examines whether a ketogenic diet adjunctive to salvage chemotherapy can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketogenic diet group | Experimental | Dietary Supplement: Ketogenic dietKetogenic diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were kept more than 2mmol/L during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded. |
| Standard diet group | Other | Dietary Supplement: Standard dietStandard diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were recorded during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60
- Karnovsky Performance Score of 60 or more.
- histologically confirmed glioblastoma multiforme, grade 4
- Ability and willingness to signed informed consent form.
- Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy.
Key exclusion criteria (5 listed)
- Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
- History of uncontrolled hyperlipidemia or hyperglycemia.
- History of human immunodeficiency virus, or hepatitis C
- Pregnancy or breastfeeding
- Inability or unwillingness of subject to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietKetogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas. | Dietary supplement | ketogenic diet group |
| Standard dietStandard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas. | Dietary supplement | Standard diet group |
Primary outcome
Number of Participants with Treatment-emergent Adverse Effects
Time frame: one year
Number of participants with treatment-emergent adverse effects while on ketogenic diet.
4 secondary outcomes
The Chemosensitivity of Tumor
Time frame: one year
Overall Survival
Time frame: one year
Ketosis
Time frame: one year
Quality of Life
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Glioblastoma Multiforme
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song Lin, M.D., principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ketogenic diet and Standard diet in people with Glioblastoma Multiforme, run by Song Lin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Song Lin, M.D., (+8601067096509, linsong2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Effects (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.