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Protocol failed to accrue sufficient subject to complete meaningful analysis.
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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.
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 debilitating complication associated with cancer treatment. Treatment of mucositis is mainly supportive - oral hygiene is the means of treatment. Curcumin (Turmeric), a frequently-used spice in India and Southeast Asia, can reduce bacterial load and prevent inflammation in cultured epithelial cells and prevent chemotherapy- and radiotherapy-induced mucositis in animal models.
The primary objective of this Phase I/II study is to determine the maximum tolerated dose (MTD) of oral curcumin in patients who have chemotherapy-induced mucositis. The secondary objectives of this study are to determine whether or not oral curcumin has an acceptable safety profile or impacts oral mucositis health outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mouthwash-standard pharmacy preparation | Active Comparator | 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 | Experimental | 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-MTD | Other | Curcumin (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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin-MTD | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Toxicities Graded by Health Care Providers Using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Zero participants analyzed. | Baseline, weekly for 5 to 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhimant Patel, MD | Aurora BayCare Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54331 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Curcumin | 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. |
| FG002 | Curcumin-MTD 0.33g Dose | 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). |
| FG003 | Curcumin-MTD 1g Dose | 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). |
| FG004 | Curcumin- MTD 2g Dose | 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). |
| FG005 | Curcumin- MTD 3g Dose | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Insufficient accrual to this protocol for meaningful analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious and Non-Serious Adverse Events | Number of Participants with Serious and Non-Serious Adverse Events. | Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze. | Posted | Count of Participants | Participants | reviewed weekly for 4 to 6 weeks |
|
2 months
Zero enrollments in Curcumin-MTD 2g dose, Curcumin-MTD 3g dose, Mouthwash Standard, and Curcumin groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dhimant Patel, MD | Aurora Health Care - Bay Area Medical Center | 920-288-4123 | dhimant.patel@aurora.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2015 | May 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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|
| Mouthwash-standard pharmacy preparation | Drug | 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 | Drug | 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. |
|
|
| Change in Subjective Patient Self-assessment of Pain. |
NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze |
| 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) | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze | 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) | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze | Baseline, then weekly for 4 to 6 weeks |
| BG001 | Curcumin | 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. |
| BG002 | Curcumin-MTD 0.33g Dose | 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). |
| BG003 | Curcumin-MTD 1g Dose | 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). |
| BG004 | Curcumin-MTD 2g Dose | 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). |
| BG005 | Curcumin-MTD 3g Dose | 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). |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| Curcumin |
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. |
| OG002 | Curcumin-MTD 0.33g Dose | 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). |
| OG003 | Curcumin-MTD 1g Dose | 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). |
| OG004 | Curcumin- MTD 2g Dose | 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). |
| OG005 | Curcumin- MTD 3g Dose | 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). |
|
|
| Secondary | Change in Toxicities Graded by Health Care Providers Using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Zero participants analyzed. | Not Posted | Baseline, weekly for 5 to 7 weeks | Participants |
| Secondary | Change in Subjective Patient Self-assessment of Pain. | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze | Not Posted | Baseline, weekly for 5 to 7 weeks | Participants |
| Secondary | 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) | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze | Not Posted | Baseline, weekly for 5 to 7 weeks | Participants |
| Secondary | 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) | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze | Not Posted | Baseline, then weekly for 4 to 6 weeks | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Curcumin | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Curcumin-MTD 0.33g Dose | 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). | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Curcumin-MTD 1g Dose | 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). | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | Curcumin-MTD 2g Dose | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Curcumin-MTD 3g Dose | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009057 |
| Stomatognathic Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|