Radiation Oncology Clinical Trials
Bacteria in the colon may play a role in how cancer in the digestive system develops and may influence the effectiveness of treatment. This study looks at how bacteria in the stool can affect the treatment response to radiation and chemotherapy for patients with cancer of the digestive system.
We are recruiting patients who have cancer of the gastrointestinal system for a donation of stool. In order to participate in this study we will send everything you need to participate which includes a consent form, a stool collection kit, and pre-paid postage boxes to return your sample to the study. In addition you will receive a medical release of information form so that we may obtain the pathology report and clinical records at your treatment facility. Once the stool is received a $50 VISA gift card will be sent to you as a thank you for your participation.
We greatly appreciate your interest in this research study!
Please contact the Primary Investigator or Study Coordinator for more information.
Primary Investigator: Dr. Jordan Kharofa, Kharofjr@ucmail.uc.edu, 513-584-4073
Study coordinator: Hope Esslinger, goodmahr@ucmail.uc.edu, 513-584-8238
| Purpose of the Study: | The purpose of this research study to test a new bra (iBRA) worn during radiation treatments for women with large breasts. We believe the iBRA may help to decrease the dose of radiation to other organs, like your heart and lungs, while still effectively treating your breast cancer. We are also looking at whether the bra is comfortable enough for our patients to wear during their planning scan and treatment. Participating in this research study is completely voluntary. Your treatment will be the same whether or not you decide to participate. |
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| Length of the Study: | If you decide to participate, you will be in this study from the time you sign the consent until your 1-month follow-up visit with your radiation oncologist. The total number of visits will depend on your treatment plan, however, there are no extra visits by participating in this study. |
| Risks: | We do not believe there are any risks to your health if you decide to be in this protocol. There is always the possibility of a breach of data. We are taking every precaution we can to ensure this does not happen. See section titled What are the Risks and Discomforts of the Research Study? for additional risks related to the study. |
| Benefits of the Study: | You may be more comfortable during your planning scan while wearing the iBRA. If you are asked to wear the iBRA during treatment, you may have fewer radiation-related side effects. The researchers do not promise that you will receive any benefits from this study. |
| Alternative procedures: | If you decide not to participate, you will receive the same treatment and care you would if you were not invited to be in this study. |
| Purpose of the Study: | The purpose of this research study is to assess the significance of the calcium buildup (calcifications) we found near your heart on your radiation planning scan. Cancer patients can also have heart disease at the same time. Because a lot of the treatments for cancer can also affect the heart, it is sometimes recommended by experts that patients have a cardiac evaluation before cancer treatment. These evaluations do not always happen because of costs, and time. Before treating cancer with radiation, most patients are required to have a CT scan that the doctor uses to plan the treatment. The same type of CT scan may also sometimes detect calcium buildup (calcification) in the arteries around the heart, a risk factor for and sign of potential heart disease. We think that using the radiation planning CT scan to also screen for heart disease could help our patients stay healthy after their cancer is treated. Participating in this research study is completely voluntary. Your treatment will be the same whether or not you decide to participate. |
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| Length of the Study: | If you decide to participate, you will be in the research study for approximately 2 years. There are NO extra visits for the research, Although, we will contact you by phone 6-, 12- and 18-24-months after your radiation treatment to ask you 4-5 questions regarding your heart health. |
| Risks: | Participation in this study poses no risks to your health or safety. There is always a small risk of a data breech when dealing with electronic data. The study staff will do everything they can to prevent a breech and will adhere strictly to the federal, state and local regulations for data safety. |
| Benefits of the Study: | If you agree to take part in this research study, there may be a direct medical benefit to you. We hope the information learned from this research study will benefit you and other patients by bringing attention to your heart health post cancer therapy. |
| Alternative procedures: | If you decide not to participate, you will receive the same treatment and care you would if you were not invited to be in this study. |
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Contact Us
Department of Radiation OncologyBarrett Cancer Center
234 Goodman Street, ML0757
Cincinnati, OH 45267-0757
Phone: 513-584-4775
Fax: 513-584-4007