MucositisPhase 1/2NCT02300727
Study to See How Safe Curcumin is and How Well it Works When Used to Treat Mucositis in Patients Getting Chemotherapy
A Phase 1/2 study testing Curcumin-MTD, Mouthwash-standard pharmacy preparation and Curcumin in people with Mucositis, run by Amy Beres at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis
- What is being tested?
- Curcumin-MTD, Mouthwash-standard pharmacy preparation and Curcumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 25 Oct 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54331
About this study
Official title: A Phase I/II Study to Determine the Safety and Efficacy of Curcumin in Patients With Oral Mucositis Secondary to Chemotherapy
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.
Read the 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
- Being tested
- Curcumin-MTD, Mouthwash-standard pharmacy preparation, Curcumin
- Keywords
- Mucositis, Neoplasms, CANCER, Curcumin, Drug Therapy, ANTINEOPLASTIC AGENTS
- Medical subject headings
- Mucositis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin-MTDDrug
Also called Curcumin, BCM-95, Tumeric
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 preparationDrug
Also called no other name
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.
CurcuminDrug
Also called BCM-95, Tumeric
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.
| Study group | Role | What they receive |
|---|---|---|
| Mouthwash-standard pharmacy preparation | Active comparator | 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. Receives: Drug: Mouthwash-standard pharmacy preparation |
| Curcumin | Experimental | 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). Receives: Drug: Curcumin |
| Curcumin-MTD | Other | 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) Receives: Drug: Curcumin-MTD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serious and Non-Serious Adverse Events
Number of Participants with Serious and Non-Serious Adverse Events.
Measured: reviewed weekly for 4 to 6 weeks
Secondary outcomes (4)
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.
Measured: Baseline, weekly for 5 to 7 weeks
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
Measured: 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)
NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze
Measured: 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)
NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze
Measured: Baseline, then weekly for 4 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Why it stopped: Protocol failed to accrue sufficient subject to complete meaningful analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amy Beres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amy Beres, Aurora BayCare Medical Center
- Investigators
- Dhimant Patel, MD, Principal investigator, Aurora BayCare Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300727
- Sponsor's protocol ID
- Curcumin:I/II
- Status last verified
- May 2019
- First submitted
- 21 Nov 2014
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Determine the Safety and Efficacy of Curcumin in Patients With Oral Mucositis Secondary to Chemotherapy
- ClinicalTrials.gov ID
- NCT02300727
- Acronym / sponsor ID
- Curcumin:I/II
- Conditions
- Mucositis
- Keywords
- Mucositis, Neoplasms, CANCER, Curcumin, Drug Therapy, ANTINEOPLASTIC AGENTS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol failed to accrue sufficient subject to complete meaningful analysis.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Amy BeresUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mouthwash-standard pharmacy preparation | Active comparator | Drug: Mouthwash-standard pharmacy preparationStandard 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 | Experimental | Drug: CurcuminCurcumin (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). |
| Curcumin-MTD | Other | Drug: Curcumin-MTDCurcumin (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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin-MTDAlso: Curcumin, BCM-95, Tumeric0.33g-3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD). | Drug | Curcumin-MTD |
| Mouthwash-standard pharmacy preparationAlso: no other nameStandard 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 |
| CurcuminAlso: BCM-95, TumericAfter 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. | Drug | Curcumin |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhimant Patel, MD principal investigator
Aurora BayCare Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Curcumin-MTD, Mouthwash-standard pharmacy preparation and Curcumin in people with Mucositis, run by Amy Beres at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious and Non-Serious Adverse Events (time frame: reviewed weekly for 4 to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.