Status:
TERMINATED
Study to See How Safe Curcumin is and How Well it Works When Used to Treat Mucositis in Patients Getting Chemotherapy
Lead Sponsor:
Amy Beres
Conditions:
Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 w...
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 debilitatin...
Eligibility Criteria
Inclusion
- ≥ grade 2 oral mucositis related to chemotherapy for cancer
- Ability to understand and the willingness to review and sign a written informed consent document.
- ≥ 18 years of age
- Willingness to use adequate contraception prior to study entry, for the duration of study participation and for 30 days after the last dose for women of child-bearing potential and men
Exclusion
- Current use of therapeutic doses of anticoagulants such as warfarin or antiplatelet agents (prophylactic doses and agents are acceptable)
- Biliary tract obstruction or cholelithiasis
- History of gastric or duodenal ulcers or hyperacidity syndromes
- AST or ALT \> 2 x ULN
- Total bilirubin ≥ 2 x ULN
- INR \> 1.5
- Previous stem cell transplant (allogeneic or autologous)
- Preexisting oral disease, such as active oral infection, trauma to the oral mucosa or oral - ulceration prior to chemotherapy
- Known allergy/hypersensitivity to curcumin, yellow food coloring, or other members of the - Zingiberaceae (ginger) family
- Pregnant or breastfeeding
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02300727
Start Date
February 1 2015
End Date
October 25 2018
Last Update
May 31 2019
Active Locations (1)
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1
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54331