Clinical trial NCT02300727: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Mucositis
Keywords: Mucositis
Neoplasms
CANCER
Curcumin
Drug Therapy
ANTINEOPLASTIC AGENTS
Lead sponsor: Aurora BayCare Medical Center
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Serious and Non-Serious Adverse Events
timeFrame: reviewed weekly for 4 to 6 weeks
Secondary outcomes:
measure: Change in Toxicities Graded by Health Care Providers Using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
timeFrame: Baseline, weekly for 5 to 7 weeks
measure: Change in Subjective Patient Self-assessment of Pain.
timeFrame: Baseline, weekly for 5 to 7 weeks
measure: 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)
timeFrame: Baseline, weekly for 5 to 7 weeks
measure: 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)
timeFrame: Baseline, then weekly for 4 to 6 weeks
Other outcomes:
Locations:
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
Study officials:
affiliation: Aurora BayCare Medical Center
name: Dhimant Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: