Clinical trial · Interventional
The Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma
A Randomized, Multicentre Pilot Trial Evaluating the Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The body's biological functions follow a circadian rhythm, meaning that individual biological functions in the body change over a 24-hour cycle. There is evidence suggesting that the body and cancer cells may react differently to anti-cancer treatment based on the time of day they are exposed. In fact, researchers have already found that giving anti-cancer treatments at a particular time of the day works better in rectal and ovarian cancer. Temozolomide (TMZ) is a chemotherapy pill/capsule commonly given to patients with newly diagnosed glioblastoma after brain surgery and radiation treatment. However, there is no current standard for what time of day TMZ should be taken for the treatment of glioblastoma. In the current study, participants are randomly placed in one of two groups: a morning group and an evening group. Based on this group placement, participants are instructed to either take their TMZ in the morning or in the evening and record the date and time they take their TMZ in a pill diary. Participants will wear a wrist actigraphy device for the first cycle of TMZ. The primary goal of the study is to understand if taking TMZ at a prescribed time of day (morning/evening) is feasible in adults with glioblastoma. This is a pilot trial, and the investigators hypothesize that it will be feasible for glioblastoma patients to take TMZ at the prescribed time of day. The secondary goals of this study are to evaluate participant recruitment, safety, health-related quality of life, biological timing of TMZ delivery, and changes in condition over time. This pilot study will help investigators plan for a larger, pragmatic randomized clinical trial in the future.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
| IDH-Wildtype Glioblastoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evening administration of TMZ | Other | — | UNRESOLVED |
| Morning administration of TMZ | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Morning administration of TMZ
- description
- Participants were instructed to take the prescribed daily dose of temozolomide (TMZ) in the morning.
- interventionNames
- Other: Morning administration of TMZ
- type
- ACTIVE_COMPARATOR
- label
- Evening administration of TMZ
- description
- Participants were instructed to take the prescribed daily dose of temozolomide (TMZ) in the evening.
- interventionNames
- Other: Evening administration of TMZ
Primary outcomes (1)
- measure
- Feasibility: adherence to TMZ dose timing protocol
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Newly diagnosed IDH-wildtype glioblastoma * Completed maximal safe brain tumor resection * Completed post-operative brain RT * Plan to proceed with up to 6 cycles of adjuvant TMZ within 8 weeks of completing post-operative RT * Able and willing to provide oral informed consent Exclusion Criteria: * Unable or unwilling to complete study questionnaires * Metastatic or incurable cancer other than IDH-wild type glioblastoma
References
Publications (1)
- BACKGROUNDJia JL, Alshamsan B, Ng TL. Temozolomide Chronotherapy in Glioma: A Systematic Review. Curr Oncol. 2023 Feb 4;30(2):1893-1902. doi: 10.3390/curroncol30020147. PMID 36826108