Mucositis Clinical Trial
Official title:
A Phase I/II Study to Determine the Safety and Efficacy of Curcumin in Patients With Oral Mucositis Secondary to Chemotherapy
Oral mucositis is a common side effect from cancer treatment. Patients receiving chemotherapy
and radiotherapy can get very painful sores in their mouth that compromise nutrition and oral
hygiene as well as increase risk for infection, and can last for weeks. Currently, the only
treatment for mucositis is oral hygiene to try to support recovery.
Curcumin (also known as Turmeric) is a frequently-used spice in India and Southeast Asia.
Studies in cells and animals have shown that it can reduce the amount of bacteria and can
prevent inflammation.
In this study, the investigators want to learn if a mouthwash made with curcumin is safe for
people to use and if it can help their mucositis.
This is a phase I/II study involving 2 parts; a dose escalation to determine the maximum
tolerated dose (MTD) of curcumin and an expansion at the MTD.
Oral mucositis is a common and often debilitating complication associated with cancer
treatment. Treatment of mucositis is mainly supportive - oral hygiene is the means of
treatment. Curcumin (Turmeric), a frequently-used spice in India and Southeast Asia, can
reduce bacterial load and prevent inflammation in cultured epithelial cells and prevent
chemotherapy- and radiotherapy-induced mucositis in animal models.
The primary objective of this Phase I/II study is to determine the maximum tolerated dose
(MTD) of oral curcumin in patients who have chemotherapy-induced mucositis. The secondary
objectives of this study are to determine whether or not oral curcumin has an acceptable
safety profile or impacts oral mucositis health outcomes.
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