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

Primary Purpose

Mucositis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Curcumin-MTD

Mouthwash-standard pharmacy preparation

Curcumin

About this trial

This is an interventional treatment trial for Mucositis focused on measuring Mucositis, Neoplasms, CANCER, Curcumin, Drug Therapy, ANTINEOPLASTIC AGENTS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aurora BayCare Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Mouthwash-standard pharmacy preparation

Curcumin

Curcumin-MTD

Arm 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.

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 (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)

Outcomes

Primary Outcome Measures

Number of Participants With Serious and Non-Serious Adverse Events

Number of Participants with Serious and Non-Serious Adverse Events.

Secondary Outcome Measures

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.

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

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

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

Full Information

NCT ID

NCT02300727

First Posted

November 21, 2014

Last Updated

May 9, 2019

Sponsor

Amy Beres

1. Study Identification

Unique Protocol Identification Number

NCT02300727

Brief Title

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

Official Title

A Phase I/II Study to Determine the Safety and Efficacy of Curcumin in Patients With Oral Mucositis Secondary to Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Terminated

Why Stopped

Protocol failed to accrue sufficient subject to complete meaningful analysis.

Study Start Date

February 2015 (undefined)

Primary Completion Date

October 25, 2018 (Actual)

Study Completion Date

October 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Amy Beres

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mucositis

Keywords

Mucositis, Neoplasms, CANCER, Curcumin, Drug Therapy, ANTINEOPLASTIC AGENTS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mouthwash-standard pharmacy preparation

Arm Type

Active Comparator

Arm 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.

Arm Title

Curcumin

Arm Type

Experimental

Arm Description

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).

Arm Title

Curcumin-MTD

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Curcumin-MTD

Other Intervention Name(s)

Curcumin, BCM-95, Tumeric

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Mouthwash-standard pharmacy preparation

Other Intervention Name(s)

no other name

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Curcumin

Other Intervention Name(s)

BCM-95, Tumeric

Intervention Description

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.

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

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

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dhimant Patel, MD

Organizational Affiliation

Aurora BayCare Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aurora BayCare Medical Center

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54331

Country

United States

12. IPD Sharing Statement

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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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