Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Marie-France Savard, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ottawa Hospital Research Institute

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.

Research Team

Marie-France Savard, MD

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

Inclusion Criteria

You are planning to take endocrine therapy.

18 years of age or older

Able to provide oral consent

Exclusion Criteria

Metastatic cancer

You have already received hormone therapy for breast cancer in the past.

Treatment Details

Interventions

• Endocrine Therapy (Hormone Therapy)

Participant Groups

Group I: Morning administration of endocrine therapy Active Control 1 Intervention

Administration of endocrine therapy defined as, within one hour of the patient wake up time

Group II: Evening administration of endocrine therapy Active Control 1 Intervention

Administration of endocrine therapy defined as, within one hour of the patient bed time

Endocrine Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Approved in Japan as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Approved in China as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Approved in Switzerland as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Thunder Bay Regional Health Sciences Centre Thunder Bay, Canada

The Ottawa Hospital Cancer Centre Ottawa, Canada

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Patients Recruited

3,283,000+