Mucositis
Conditions
Keywords
Mucositis, Neoplasms, CANCER, Curcumin, Drug Therapy, ANTINEOPLASTIC AGENTS
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.
Detailed description
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.
Interventions
DRUGCurcumin-MTD
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).
DRUGMouthwash-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.
DRUGCurcumin
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.
Sponsors
Amy Beres
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious and Non-Serious Adverse Events | reviewed weekly for 4 to 6 weeks | Number of Participants with Serious and Non-Serious Adverse Events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Zero participants analyzed. |
| Change in Subjective Patient Self-assessment of Pain. | Baseline, weekly for 5 to 7 weeks | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze |
| 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 | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze |
| 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 | NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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 |
| 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). | 3 |
| 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). | 3 |
| 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). | 0 |
| 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). | 0 |
| Total | 6 |
Baseline characteristics
| Characteristic | Curcumin-MTD 0.33g Dose | Curcumin-MTD 1g Dose | Curcumin-MTD 2g Dose | Curcumin-MTD 3g Dose | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 3 | 0 / 3 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 3 | 0 / 3 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 3 | 0 / 3 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Serious and Non-Serious Adverse Events
Number of Participants with Serious and Non-Serious Adverse Events.
Time frame: reviewed weekly for 4 to 6 weeks
Population: Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mouthwash-standard Pharmacy Preparation | Number of Participants With Serious and Non-Serious Adverse Events | 0 Participants |
| Curcumin | Number of Participants With Serious and Non-Serious Adverse Events | 0 Participants |
| Curcumin-MTD 0.33g Dose | Number of Participants With Serious and Non-Serious Adverse Events | 0 Participants |
| Curcumin-MTD 1g Dose | Number of Participants With Serious and Non-Serious Adverse Events | 0 Participants |
| Curcumin- MTD 2g Dose | Number of Participants With Serious and Non-Serious Adverse Events | 0 Participants |
| Curcumin- MTD 3g Dose | Number of Participants With Serious and Non-Serious Adverse Events | 0 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
Time frame: Baseline, then weekly for 4 to 6 weeks
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
Time frame: Baseline, weekly for 5 to 7 weeks
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
Time frame: Baseline, weekly for 5 to 7 weeks
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.
Time frame: Baseline, weekly for 5 to 7 weeks