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.
18 years of age or older
Newly diagnosed IDH-wildtype glioblastoma
Completed maximal safe brain tumor resection
Completed post-operative brain RT
Unable or unwilling to complete study questionnaires
Metastatic or incurable cancer other than IDH-wild type glioblastoma
Parallel
Morning administration of TMZ
Other interventionAdministration of TMZ within 2 hours of waking
Evening administration of TMZ
Other interventionAdministration of TMZ within 2 hours of bedtime
Feasibility: adherence to TMZ dose timing protocol
The primary outcome is feasibility for patients to receive temozolomide (TMZ) according to their assigned dose timing. Feasibility is measured by at least 80% adherence to the assigned TMZ dose timing. Adherence is calculated based on patient entries in a daily pill diary.
Participant recruitment: proportion of patients providing consent to participate
The number of patients who provided consent for study participation over the total number of patients approached and invited to participate in the clinical study
Participant recruitment: participant withdrawal rate and reasons
Proportion of eligible patients who consented to the study, but subsequently withdrew from study prior to starting the first cycle of adjuvant temozolomide (TMZ)
Participant recruitment: rate of patient enrollment
The rate of patient enrollment is defined by the number of new study participants who were randomized per center (average number of patients per month)
Safety: rate of hospital admissions
Rate of hospital admissions per patient defined as the number of discrete admissions to acute care facility.
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Ottawa Hospital Research Institute
Lead sponsor
The Ottawa Hospital
Collaborator
