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RecruitingPHASE4INTERVENTIONAL

Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers

This study, called REaCT-CHRONO-MetBP, is for people with advanced breast or prostate cancer. It's investigating if the time of day you take certain hormone-based cancer medicines (either in the morning or evening) has any impact. Participants will be randomly assigned to take their medication at a specific time. The main goal is to see if the study procedures are clear and easy to follow, to prepare for a larger study later on. Researchers will also look at how these different timings affect a person's quality of life, any side effects, and how well the treatment works for both types of cancer.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Ottawa Hospital Research Institute
Enrolment target
50
Start
02 Feb 2026
Estimated completion
01 Mar 2033

What is this study about?

This study is called REaCT-CHRONO-MetBP, and it's looking into how the timing of certain cancer medications might affect people with advanced breast or prostate cancer. You might already be taking a specific type of hormone-based treatment. This study wants to find out if it makes a difference whether you take these medicines in the morning or in the evening. This includes medicines for breast cancer like CDK4/6 inhibitors (such as Ribociclib or Palbociclib) and for prostate cancer, medicines like androgen receptor pathway inhibitors (such as enzalutamide, apalutamide, or abiraterone acetate).

The main purpose of this pilot study isn't to directly find a new treatment, but rather to test how well the study itself works. Think of it as a practice run to make sure everything is clear and achievable before a much larger study begins. If this pilot study shows that the procedures are sound, it will help researchers design a bigger, more definitive study in the future.

Even though it's a pilot study, researchers will still be paying close attention to other important things. They will compare how people in the morning group and the evening group feel, including their overall quality of life. They'll also track any side effects to see if one timing is better tolerated than the other, and how effective the treatments are for both breast and prostate cancer patients. This valuable information will help shape future research into improving cancer care.

Key takeaways

  • This study explores taking cancer medicine in the morning vs. evening for advanced breast or prostate cancer.
  • It's a 'pilot' study, designed to test the study procedures for future, larger research.
  • You'll be randomly assigned to a morning or evening medication schedule.
  • Researchers will also check quality of life, side effects, and treatment effectiveness.
  • Participation will help improve future understanding of cancer treatment timing.

Who may be eligible?

To join the study, you need to be at least 18 years old and have advanced breast cancer that's hormone-sensitive, meaning it responds to hormone treatments, or have advanced prostate cancer that's hormone-sensitive. For breast cancer, you would need to be starting a specific combination of hormone therapy and a medicine called a CDK4/6 inhibitor (like Ribociclib or Palbociclib). For prostate cancer, you would be taking a certain type of hormone treatment called an androgen receptor pathway inhibitor (like enzalutamide, apalutamide, or abiraterone acetate) along with other hormone therapy.

It's important that you don't have any medical reasons that would prevent you from taking your medication at either a morning or evening time. For breast cancer, if your treatment plan includes a medicine called abemaciclib, you wouldn't be able to join because it needs to be taken twice a day, which wouldn't work with the study's specific timing focus. Similarly, for prostate cancer, if your plan includes darolutamide (also a twice-a-day medicine) or a chemotherapy drug called docetaxel with your hormone treatment, you wouldn't be eligible. You also need to be able to understand the study and fill out questionnaires as part of it.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have advanced breast or prostate cancer that is hormone-sensitive?
  3. Are you starting specific hormone-based treatments (CDK4/6 inhibitor for breast, ARPI for prostate)?
  4. Are you able to take your medicine either in the morning or evening?
  5. Are you able to fill out questionnaires about how you're feeling?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly put into one of two groups: a morning group or an evening group. This means you'll be told whether to take your specific cancer medication either in the morning or in the evening. You will have regular contact with the study team, and you'll be asked to fill out questionnaires about how you're feeling and your quality of life. The study will also involve standard medical check-ups and assessments, similar to what you'd have during regular cancer treatment, to monitor your health and how the treatment is working. The exact number of visits and the full duration of your participation will be discussed in detail by the study staff.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as contributing to important research that could improve future cancer care for others. While there are no direct guarantees of personal benefit from taking your medication at a specific time, monitoring your well-being, quality of life, and treatment effectiveness is part of the study. As with all clinical trials, there's a possibility of risks, including potential side effects from the medication or the inconvenience of study visits. Your medical team will carefully explain all known risks associated with your treatment. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (3)

  • Waterloo Regional Health Network
    Verified postcode
    Kitchener, Canada· Recruiting
  • The Ottawa Hospital Cancer Centre
    Verified postcode
    Ottawa, Canada· Recruiting
  • Saskatoon Cancer Centre
    Verified postcode
    Saskatoon, Canada· Not yet recruiting

Common questions

What is a 'pilot' study?

A pilot study is like a test run for a larger study. Its main goal is to check if the study plan and procedures are clear and easy to follow before they run a much bigger one.

What does 'randomly placed' mean?

It means a computer will decide whether you're in the morning medicine group or the evening medicine group, like flipping a coin. Neither you nor your doctor can choose which group you're in.

Will my regular cancer treatment change?

No, you will still receive your planned hormone-based cancer treatment. The study is only looking at whether you take that treatment in the morning or evening.

What is 'quality of life' in this study?

Quality of life looks at how your treatment affects your well-being, feelings, and daily activities. You'll likely answer questionnaires about this.

Can I stop participating if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, and it will not affect your ongoing medical care.

How to find out more

Lisa Vandermeer, MSc

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluating Dose Timing (Morning vs Evening) of Endocrine-bas…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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