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Trial record 28 of 162 for:    curcumin

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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ClinicalTrials.gov Identifier: NCT02300727
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Mucositis Drug: Curcumin-MTD Drug: Mouthwash-standard pharmacy preparation Drug: Curcumin Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study to Determine the Safety and Efficacy of Curcumin in Patients With Oral Mucositis Secondary to Chemotherapy
Study Start Date : February 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : October 2018
Arms and Interventions

Arm Intervention/treatment
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.

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
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).
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
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)

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


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: reviewed weekly for 4 to 6 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in subjective patient self-assessment of pain. [ Time Frame: Baseline, weekly for 5 to 7 weeks ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 colorings, or other members of the - Zingiberaceae (ginger) family
  • Pregnant or breastfeeding
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300727


Contacts
Contact: Sarah Peterson, RN 920-288-4123 sarah.peterson@aurora.org
Contact: Corinne Zipperer, RN 920-288-4123 corinne.zipperer@aurora.org

Locations
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54331
Sponsors and Collaborators
Dhimant Patel
Investigators
Principal Investigator: Dhimant Patel, MD Aurora BayCare Medical Center
More Information

Responsible Party: Dhimant Patel, Oncology Physician, Aurora BayCare Medical Center
ClinicalTrials.gov Identifier: NCT02300727     History of Changes
Other Study ID Numbers: Curcumin:I/II
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016

Keywords provided by Dhimant Patel, Aurora BayCare Medical Center:
Mucositis
Neoplasms
CANCER
Curcumin
Drug Therapy
ANTINEOPLASTIC AGENTS

Additional relevant MeSH terms:
Curcumin
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action