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
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Study Type | Interventional |
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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 |
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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 | |
---|---|---|---|---|---|---|---|---|
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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 | |
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Insufficient accrual to this protocol for meaningful analysis.
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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%
|
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Between 18 and 65 years |
3 100.0%
|
3 100.0%
|
0 | 0 |
6 100.0%
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|||
>=65 years |
0 0.0%
|
0 0.0%
|
0 | 0 |
0 0.0%
|
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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%
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1 33.3%
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0 | 0 |
2 33.3%
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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.
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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 |