Primary objective:To assess the feasibility of KD in patients with glioblastoma multiforme during standard treatment.Secundary objectives:- To determine number of patients not being able to start protocol treatment (i.e. not able to reach ketosis,…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of KD during standard treatment with RT and CT defined as
successfully following the KD for 14 weeks after start of protocol treatment.
So a patient is considered a failure for the primary endpoint if the KD is
followed for less than 14 weeks from start of protocol treatment.
Secondary outcome
- Number of days on KD after start protocol treatment
- Compliance to the KD reflected in adequate and stable ketosis (3-4 mmol/l).
- Number of withdrawals or not reaching ketosis <3 mmol/L during the first 10
days of the KD
- Overall survival (OS) defined as time from diagnosis till date of death
- Progression free survival (PFS) defined as time from diagnosis till tumor
progression or death (whichever comes first).
- Evaluation of neurological functioning will be evaluated by using the
Vineland behavior scale (Appendix X) at baseline, after 8 weeks and at end of
protocol treatment.
- Toxicity (i.e. adverse events CTCAE grade * 2).
Background summary
Previous research has shown that the use of ketogenic diet has two potentially
beneficial effects in the treatment of cancer; the sensitization of tumor cells
to the toxic effects of radiation and protection of normal tissues from the
toxic side effects of chemotherapy.
Study objective
Primary objective:
To assess the feasibility of KD in patients with glioblastoma multiforme during
standard treatment.
Secundary objectives:
- To determine number of patients not being able to start protocol treatment
(i.e. not able to reach ketosis, or not being able to follow the KD for the
first 10 days.
- To evaluate treatment effects in terms of overall survival (OS) and
Progression free survival (PFS)
- To investigate the neurologic condition (on Vineland adaptive scale)
Study design
Phase I, open label, single center, non-randomized prospective feasibility
study
Intervention
Addition of KD to standard treatment.
Study burden and risks
The standard treatment of GBM patients consists of tumor resection followed by
combined RT and chemotherapy (CT) for a period of six weeks after surgery and
subsequent monthly cycles of chemotherapy mostly during six months. During
standard treatment the patient will receive KD during the study period of 14
weeks. The patient follows a strict diet with high fat and low carbohydrate
content which induces ketosis. The patient will be closely monitored by a
specialized dietitian and nurse practitioner. The patient related possible
risks of the combination of standard treatment and KD are classified as low
based on a previous explorative study performed elsewhere. During the 14weeks
study period, safety and feasibility will be assessed by registering the
adverse effects of standard treatment and KD, quality of life, protocol
compliance and neurological functioning.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Part A:
- Histologically proven GBM (Astrocytoma WHO grade 4) after surgical resection
- Age * 18 years.
- Not dexamethasone dependent after surgery
- Amenable and planned for standard RT and CT and starting within 6 weeks after enrolment.
- Supportive partner or family member who can and is willing to help calculating, preparing and providing the meals.
- KPS *70.
- Written informed consent
- Able and willing to complete study specific diaries and questionnaires.
- Able to understand the procedures and instructions and able to give informed consent;Part B:
- Able to reach 3+ mmol/L ketosis within one week on the KD
- Abe to follow the KD during ketosis, for at least 3 days
Exclusion criteria
- Neurological deficit in language or cognitive functions causing inability to fully understand the study protocol and requirements
- Dementia or amnesia
- History of psychiatric disorder that would prohibit the understanding and giving of informed consent.
- The use of dexamethasone at time of registration
- Fatty acid disorders (like Medium Chain triglycerides disorders)
- Hypertriglyceridemia (> 10 mmol/L) despite treatment
- Hypercholesterolemia (> 7.5 mmol/L) despite treatment
- Alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) >2.5x ULN
- (History of) Kidney stones
- Diabetes mellitus
- (History of) Pancreatitis
- Acute/chronic gastro-intestinal disease(s) such as persistent diarrhea, colitis ulcerosa and M. Crohn
- Underweight (BMI < 16)
- Overweight (BMI >30)
- Untreated or uncontrolled hypertension
- Any other chronic or systemic disease or serious medical condition (other than related to GBM), that may influence protocol compliance or outcomes of the study significantly
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50625.078.14 |
| OMON | NL-OMON19917 |