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

• ClinicalTrials.gov Identifier: NCT02300727
• Recruitment Status: Terminated
• First Posted: November 25, 2014
• Results First Posted: May 31, 2019
• Last Update Posted: May 31, 2019
• Sponsor: Amy Beres
• Information provided by (Responsible Party): Amy Beres, Aurora BayCare Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Mucositis
• Interventions: Drug: Curcumin-MTD; Drug: Mouthwash-standard pharmacy preparation; Drug: Curcumin
• Enrollment: 6

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Mouthwash-standard Pharmacy Preparation	Curcumin	Curcumin-MTD 0.33g Dose	Curcumin-MTD 1g Dose	Curcumin- MTD 2g Dose	Curcumin- MTD 3g Dose
Arm/Group Description	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. Mouthwash-standard pharmacy preparation: 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.	Curcumin (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: 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.	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participant at a dose level of 0.33g per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 0.33g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participant at a dose level of 1g per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 1g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participant at a dose level of 2g per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 2g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participant at a dose level of 3g per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).
Period Title: Overall Study
Started	0	0	3	3	0	0
Completed	0	0	3	2	0	0
Not Completed	0	0	0	1	0	0

Baseline Characteristics

Arm/Group Title		Mouthwash-standard Pharmacy Preparation	Curcumin	Curcumin-MTD 0.33g Dose	Curcumin-MTD 1g Dose	Curcumin-MTD 2g Dose	Curcumin-MTD 3g Dose	Total
Arm/Group Description		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. Mouthwash-standard pharmacy preparation: 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.	Curcumin (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: 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.	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participant at a dose of 0.33g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 0.33g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participant at a dose of 1g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 1g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participant at a dose of 2g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 2g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participant at a dose of 3g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Total of all reporting groups
Overall Number of Baseline Participants		0	0	3	3	0	0	6
Baseline Analysis Population Description		Insufficient accrual to this protocol for meaningful analysis.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	3 participants	3 participants	0 participants	0 participants	6 participants
	<=18 years			0 0.0%	0 0.0%	0	0	0 0.0%
	Between 18 and 65 years			3 100.0%	3 100.0%	0	0	6 100.0%
	>=65 years			0 0.0%	0 0.0%	0	0	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	3 participants	3 participants	0 participants	0 participants	6 participants
	Female			2 66.7%	2 66.7%	0	0	4 66.7%
	Male			1 33.3%	1 33.3%	0	0	2 33.3%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
								0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Serious and Non-Serious Adverse Events
Description	Number of Participants with Serious and Non-Serious Adverse Events.
Time Frame	reviewed weekly for 4 to 6 weeks

Outcome Measure Data

Analysis Population Description

Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze.

Arm/Group Title	Mouthwash-standard Pharmacy Preparation	Curcumin	Curcumin-MTD 0.33g Dose	Curcumin-MTD 1g Dose	Curcumin- MTD 2g Dose	Curcumin- MTD 3g Dose
Arm/Group Description:	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. Mouthwash-standard pharmacy preparation: 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.	Curcumin (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: 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.	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participants at a dose of 0.33g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 0.33g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participants at a dose of 1g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 1g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participants at a dose of 2g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 2g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participants at a dose of 3g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).
Overall Number of Participants Analyzed	0	0	3	3	0	0
Measure Type: Count of Participants; Unit of Measure: Participants
	0	0	0 0.0%	0 0.0%	0	0

2. Secondary Outcome

Title	Change in Toxicities Graded by Health Care Providers Using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Description	NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Zero participants analyzed.
Time Frame	Baseline, weekly for 5 to 7 weeks

Outcome Measure Data Not Reported

3. Secondary Outcome

Title	Change in Subjective Patient Self-assessment of Pain.
Description	NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze
Time Frame	Baseline, weekly for 5 to 7 weeks

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	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)
Description	NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze
Time Frame	Baseline, weekly for 5 to 7 weeks

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	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)
Description	NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze
Time Frame	Baseline, then weekly for 4 to 6 weeks

Outcome Measure Data Not Reported

Adverse Events

Time Frame	2 months
Adverse Event Reporting Description	Zero enrollments in Curcumin-MTD 2g dose, Curcumin-MTD 3g dose, Mouthwash Standard, and Curcumin groups.
Arm/Group Title	Mouthwash-standard Pharmacy Preparation	Curcumin	Curcumin-MTD 0.33g Dose	Curcumin-MTD 1g Dose	Curcumin-MTD 2g Dose	Curcumin-MTD 3g Dose
Arm/Group Description	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. Mouthwash-standard pharmacy preparation: 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.	Curcumin (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: 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.	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participants at a dose of 0.33g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 0.33g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participants at a dose of 1g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 1g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participants at a dose of 2g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 2g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).	Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD). There will be 3 participants at a dose of 3g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs) Curcumin-MTD: 3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).
All-Cause Mortality
	Mouthwash-standard Pharmacy Preparation	Curcumin	Curcumin-MTD 0.33g Dose	Curcumin-MTD 1g Dose	Curcumin-MTD 2g Dose	Curcumin-MTD 3g Dose
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/3 (0.00%)	0/3 (0.00%)	0/0	0/0
Serious Adverse Events
	Mouthwash-standard Pharmacy Preparation	Curcumin	Curcumin-MTD 0.33g Dose	Curcumin-MTD 1g Dose	Curcumin-MTD 2g Dose	Curcumin-MTD 3g Dose
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/3 (0.00%)	0/3 (0.00%)	0/0	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Mouthwash-standard Pharmacy Preparation	Curcumin	Curcumin-MTD 0.33g Dose	Curcumin-MTD 1g Dose	Curcumin-MTD 2g Dose	Curcumin-MTD 3g Dose
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/3 (0.00%)	0/3 (0.00%)	0/0	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dhimant Patel, MD
• Organization: Aurora Health Care - Bay Area Medical Center
• Phone: 920-288-4123
• EMail: dhimant.patel@aurora.org

• Responsible Party: Amy Beres, Aurora BayCare Medical Center
• ClinicalTrials.gov Identifier: NCT02300727
• Other Study ID Numbers: Curcumin:I/II
• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Results First Submitted: March 25, 2019
• Results First Posted: May 31, 2019
• Last Update Posted: May 31, 2019