Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-21 @ 6:52 PM
Study NCT ID:
NCT02300727
Status:
TERMINATED
Last Update Posted:
2019-05-31
First Post:
2014-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to See How Safe Curcumin is and How Well it Works When Used to Treat Mucositis in Patients Getting Chemotherapy
Sponsor:
Amy Beres
Organization:
Study Overview
Official Title:
A Phase I/II Study to Determine the Safety and Efficacy of Curcumin in Patients With Oral Mucositis Secondary to Chemotherapy
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol failed to accrue sufficient subject to complete meaningful analysis.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: