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

NCT ID: NCT02300727

Last Updated: 2019-05-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-10-25

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.

Conditions

Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Mouthwash-standard pharmacy preparation

Intervention Type: 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

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).

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: 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.

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)

Group Type: OTHER

Curcumin-MTD

Intervention Type: 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).

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Curcumin; BCM-95; Tumeric; no other name; BCM-95; Tumeric

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amy Beres

OTHER

Sponsor Role: lead

Responsible Party

Amy Beres

Oncology Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dhimant Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Aurora BayCare Medical Center

Locations

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Curcumin:I/II

Identifier Type: -

Identifier Source: org_study_id