The REaCT-CHRONO-MetBP Pilot study will compare morning and evening administration of endocrine-based therapy in metastatic breast and prostate cancers. Participants with metastatic breast or prostate cancer will be randomly placed in one of two groups: a morning group and an evening group. The group assignment will determine whether they take their endocrine therapy in the morning or the evening. The primary outcome of this pilot study is to evaluate the feasibility of study procedures in order to conduct a larger definitive trial in the future. The secondary outcomes include comparing quality of life, tolerability, and efficacy outcomes between the morning and evening groups for each of the two cancer cohorts (metastatic breast and prostate cancer).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Morning administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant wake up time.
Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
Waterloo Regional Health Network
Kitchener, Ontario, Canada
RECRUITINGThe Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
RECRUITINGSaskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
NOT_YET_RECRUITINGFeasibility: accrual per site
Feasibility will be assessed according to a combination of metrics, including the accrual of at least 25 patients per cohort in one year for a total of three sites
Time frame: 1 year
Feasibility: participation rate
Feasibility will be assessed according to a combination of metrics, including participation rate of at least 60% among patients approached.
Time frame: The accrual period, approximately 1 year
Feasibility: number of participants who received allocated intervention
Feasibility will be assessed according to a combination of metrics, including at least 80% of enrolled patients receive treatment as per their allocated intervention for at least 4 weeks.
Time frame: 4 weeks
Health-related quality of life: Functional Assessment of Cancer Therapy-General
Health-related quality of life using Functional Assessment of Cancer Therapy-General (FACT-G). Cohort A and Cohort B will answer the FACT-G. FACT-G has a score range of 0 to 108. Higher scores indicate better quality of life.
Time frame: Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Health-related quality of life: Functional Assessment of Cancer Therapy-Endocrine Symptoms
Health-related quality of life using Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES). Cohort A and Cohort B will answer the FACT-ES. FACT-ES has a score range of 0 to 184. Higher scores indicate better quality of life.
Time frame: Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Health-related quality of life: Functional Assessment of Cancer Therapy-Breast
Health-related quality of life using Functional Assessment of Cancer Therapy-Breast (FACT-B). Cohort A will complete the FACT-B. FACT-B has a score range of 0 to 148. Higher scores indicate better quality of life.
Time frame: Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Health-related quality of life: Functional Assessment of Cancer Therapy-Prostate
Health-related quality of life using Functional Assessment of Cancer Therapy-Prostate (FACT-P). Cohort B will complete the FACT-P. FACT-P has a score range of 0 to 156. Higher scores indicate better quality of life.
Time frame: Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Number of changes in treatment dose
Time frame: 5 years
Number of treatment interruptions
Time frame: 5 years
Number of treatment discontinuations
Time frame: 5 years
Cohort A's adverse events of interest
The number of participants in Cohort A that experience QTc prolongation, neutropenia, febrile neutropenia, hepatobiliary function.
Time frame: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Cohort B's adverse events of interest
The number of participants in Cohort B that experience hypertension, hyperglycemia, rash, hypothyroidism, fatigue.
Time frame: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Adherence to treatment
Adherence to treatment measured by the Five-Item Medication Adherence Report Scale (MARS-5 score). The MARS-5 has a range of 5-25. Higher scores indicate high adherence.
Time frame: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Participant preference in dose timing
Participants rank their preference on a scale of 0 to 10, where 0=prefer to take treatment in the morning, 5=no preference, 10=prefer to take treatment in the evening.
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.