Research Study - Mouthsores

University of Connecticut - Mouthsores Study
Cyclooxygenase-2 Inhibition in Radiation-induced Oral Mucositis

The University of Connecticut is conducting a mouthsore study. The purpose of this study is to test the usefulness of a prescription pain medication in reducing the pain and severity of mouthsores that may develop as a result of radiation therapy and to test whether this drug is helpful in treating cancer itself.

The pain medication to be studied is called celecoxib, and is marketed under the brand name Celebrex®, as is FDA approved to reduce pain and inflammation in patients suffering from arthritis. It has also been approved to reduce the number of precancerous polyps in the intestine. However, it is not known whether this medication is useful in reducing mouthsores due to radiation or in treating the cancer itself.

General Eligibility Criteria:

Adults aged 18 - 75 who will be receiving at least 5000 cGy radiation therapy to at least 2 of 14 pre-defined areas in the mouth and throat.

Possible benefits from taking part in this study:

1. The study drug may reduce the pain and severity of your mouth sores.

2. The study drug may help in treating your cancer.

Financial Compensation

You will be compensated $75 at the end of the study if you complete 90% of study drug doses and 90% of study visits. In addition, up to four times during the study you will have the opportunity to give a small blood sample (about 2 teaspoons) and a very small sample of mouth tissue. These samples are optional, you can still take part in this study even if you do not wish to give these samples. If you choose to give a sample, you will be compensated $25 for each blood sample and $100 for each tissue sample that you give.

This study will be carried out at the University of Connecticut Health Center where you will be receiving your radiation therapy. For further information, please contact Dr. Lalla or Dr. Peterson at 860-679-2952 or 860-679-2974. You may also download a flyer here.