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Trial record 17 of 80 for:    "curcumin" and "cancer"

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

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ClinicalTrials.gov Identifier: NCT02300727
Recruitment Status : Terminated (Protocol failed to accrue sufficient subject to complete meaningful analysis.)
First Posted : November 25, 2014
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
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
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
Hide 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
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
Hide 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
Hide 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.
1.Primary Outcome
Title Number of Participants With Serious and Non-Serious Adverse Events
Hide Description Number of Participants with Serious and Non-Serious Adverse Events.
Time Frame reviewed weekly for 4 to 6 weeks
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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.
Hide 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)
Hide 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)
Hide 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
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
Hide 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 
Show Serious Adverse Events Hide 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 
Show Other (Not Including Serious) Adverse Events Hide 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 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dhimant Patel, MD
Organization: Aurora Health Care - Bay Area Medical Center
Phone: 920-288-4123
EMail: dhimant.patel@aurora.org
Layout table for additonal information
Responsible Party: Amy Beres, Aurora BayCare Medical Center
ClinicalTrials.gov Identifier: NCT02300727     History of Changes
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