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

Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02300727
• Other study ID #: Curcumin:I/II
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2015
• Est. completion date: October 25, 2018

Study information

• Verified date: May 2019
• Source: Aurora BayCare Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mucositis

Intervention

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).
• 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
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.

Locations

Country	Name	City	State
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Amy Beres

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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.	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	Baseline, weekly for 5 to 7 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	Baseline, weekly for 5 to 7 weeks
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	Baseline, then weekly for 4 to 6 weeks