Clinical Trial: Study to See How Safe Curcumin is and How Well it Works When Used to Treat Mucositis in Patients Getting Chemotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I/II Study to Determine the Safety and Efficacy of Curcumin in Patients With Oral Mucositis Secondary to Chemotherapy

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.


Detailed Summary:

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.


Sponsor: Dhimant Patel

Current Primary Outcome: Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: reviewed weekly for 4 to 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in toxicities graded by health care providers using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Baseline, weekly for 5 to 7 weeks ]
  • Change in subjective patient self-assessment of pain. [ Time Frame: Baseline, weekly for 5 to 7 weeks ]
  • Change in subjective patient self- assessment of oral mucositis measured by the Common Terminology Criteria for Adverse Events (CTCAE) and World Health Organization's (WHO's) Oral Toxicity Scale (OTS) [ Time Frame: Baseline, weekly for 5 to 7 weeks ]
  • Change in health providers assessment of oral mucositis and healing time measured by the Common Terminology Criteria for Adverse Events (CTCAE) and World Health Organization's (WHO's) Oral Toxicity Scale (OTS) [ Time Frame: Baseline, then weekly for 4 to 6 weeks ]


Original Secondary Outcome: Same as current

Information By: Aurora BayCare Medical Center

Dates:
Date Received: November 21, 2014
Date Started: February 2015
Date Completion: October 2018
Last Updated: December 27, 2016
Last Verified: December 2016