Study Stopped
Protocol failed to accrue sufficient subject to complete meaningful analysis.
Study to See How Safe Curcumin is and How Well it Works When Used to Treat Mucositis in Patients Getting Chemotherapy
A Phase I/II Study to Determine the Safety and Efficacy of Curcumin in Patients With Oral Mucositis Secondary to Chemotherapy
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2014
CompletedFirst Posted
Study publicly available on registry
November 25, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2018
CompletedResults Posted
Study results publicly available
May 31, 2019
CompletedMay 31, 2019
May 1, 2019
3.7 years
November 21, 2014
March 25, 2019
May 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Serious and Non-Serious Adverse Events
Number of Participants with Serious and Non-Serious Adverse Events.
reviewed weekly for 4 to 6 weeks
Secondary Outcomes (4)
Change in Toxicities Graded by Health Care Providers Using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Baseline, weekly for 5 to 7 weeks
Change in Subjective Patient Self-assessment of Pain.
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)
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)
Baseline, then weekly for 4 to 6 weeks
Study Arms (3)
Mouthwash-standard pharmacy preparation
ACTIVE COMPARATORStandard mouth wash preparation administered by ingested mouth rinse three times per day. The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine.
Curcumin
EXPERIMENTALCurcumin (BCM-95) administered by ingested mouth rinse three times per day. Subjects will be in this arm at the previously determine maximum tolerated dose (MTD).
Curcumin-MTD
OTHERCurcumin (BCM-95) administered by ingested mouth rinse. A total of 12-15 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participant at each of 4 does levels (0.33g, 1g, 2g, 3g) per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)
Interventions
0.33g-3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).
Standard mouth wash preparation administered by ingested mouth rinse three times per day. The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine.
After maximum tolerated dose (MTD) is determined, MTD by ingested mouth wash three times per day for 4-6 weeks until mucositis is resolved, disease progression, or unacceptable toxicity develops.
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amy Bereslead
Study Sites (1)
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54331, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dhimant Patel, MD
- Organization
- Aurora Health Care - Bay Area Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Dhimant Patel, MD
Aurora BayCare Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Oncology Physician
Study Record Dates
First Submitted
November 21, 2014
First Posted
November 25, 2014
Study Start
February 1, 2015
Primary Completion
October 25, 2018
Study Completion
October 25, 2018
Last Updated
May 31, 2019
Results First Posted
May 31, 2019
Record last verified: 2019-05