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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 21, 2014
First Posted Date  ICMJE November 25, 2014
Results First Submitted Date  ICMJE March 25, 2019
Results First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Study Start Date  ICMJE February 2015
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: reviewed weekly for 4 to 6 weeks ]
Number of Participants with Serious and Non-Serious Adverse Events.
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: reviewed weekly for 4 to 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Change in Toxicities Graded by Health Care Providers Using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
  • Change in Toxicities Graded by Health Care Providers Using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Baseline, weekly for 5 to 7 weeks ]
  • Change in Subjective Patient Self-assessment of Pain. [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline, then weekly for 4 to 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to See How Safe Curcumin is and How Well it Works When Used to Treat Mucositis in Patients Getting Chemotherapy
Official Title  ICMJE A Phase I/II Study to Determine the Safety and Efficacy of Curcumin in Patients With Oral Mucositis Secondary to Chemotherapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mucositis
Intervention  ICMJE
  • Drug: Curcumin-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).
    Other Names:
    • Curcumin
    • BCM-95
    • Tumeric
  • Drug: 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.

    Other Name: no other name
  • Drug: 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.
    Other Names:
    • BCM-95
    • Tumeric
Study Arms  ICMJE
  • Active Comparator: 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.

    Intervention: Drug: Mouthwash-standard pharmacy preparation
  • Experimental: 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).
    Intervention: Drug: Curcumin
  • Curcumin-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)

    Intervention: Drug: Curcumin-MTD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
6
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2014)
38
Actual Study Completion Date  ICMJE October 25, 2018
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300727
Other Study ID Numbers  ICMJE Curcumin:I/II
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amy Beres, Aurora BayCare Medical Center
Study Sponsor  ICMJE Amy Beres
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dhimant Patel, MD Aurora BayCare Medical Center
PRS Account Aurora BayCare Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP