A randomised controlled feasibility study assessing the feasibility of a probiotic-use and dietary counselling intervention for endometrial cancer patients receiving pelvic radiation therapy.
About this trial
The MICRO GI Feasibility is currently open at:
- St. Luke’s Radiation Oncology Network (SLRON)
What is the goal of this study?
The MICRO-GI study aims to find out whether it is practical and acceptable for women receiving pelvic radiotherapy for endometrial cancer to take daily probiotic supplements and receive personalised dietary counselling.
The study is checking:
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if patients are comfortable taking probiotics regularly,
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if attending dietitian appointments works well, and
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if collecting stool samples, questionnaires, and blood tests is manageable.
If this smaller feasibility study shows that the process works well and patients find it acceptable, it will lead to a larger future study to see whether probiotics and dietary advice can help reduce gut-related side effects from radiotherapy.
What will happen to patients if they take part?
All patients are already receiving pelvic radiotherapy as part of their standard treatment for endometrial cancer. The study will include 40 patients, and a computer will randomly assign each person to one of two groups.
If you receive the study treatment (intervention group):
You will take one probiotic sachet every day.
You start three weeks before radiotherapy, continue during treatment, and finish four weeks after radiotherapy ends.
You will meet with a dietitian for personalised dietary counselling once before radiotherapy, twice during treatment, and again four weeks after radiotherapy.
If you receive standard care (comparison group):
You receive your usual radiotherapy treatment. You may still see a dietitian if your doctor feels it would help with managing gut-related side effects.
Tests and assessments
Some are routine, while others are added because of the study:
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Blood tests to check your general health and inflammation levels.
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Stool samples at three timepoints (before radiotherapy, during the last week of treatment, and three months afterward) to study changes in gut bacteria.
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Quality-of-life questionnaires before, during, and after radiotherapy to understand how treatment affects daily life.
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Regular check-ups with your radiation oncology team throughout treatment and follow-up visits up to six months afterward.
Some appointments may be slightly longer than usual, especially if you are seeing the dietitian on the same day.
Who can take part?
You may be eligible if:
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You have endometrial cancer and will be receiving pelvic radiotherapy.
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You are well enough for treatment and have suitable blood test results.
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There is no reason why you cannot take probiotics (for example if you already take them regularly).
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- Your doctor confirms that you meet all the criteria for the trial.
Study Oversight
Professor Alex Boychak is the Chief Investigator of this study.
The study is sponsored by the HSE.
This is an Irish led study designed by Professor Boychak, and developed with the input of the team at SLRON including the clinical trials unit and the dietetics department. Fiona Roulston, the head of dietetics at SLRON, contributed significantly to the protocol development and running of the study,