Head and Neck CancerEarly Phase 1NCT01160302
Curcumin Biomarker Trial in Head and Neck Cancer
A Early Phase 1 study testing Microgranular Curcumin C3 Complex® in people with Head and Neck Cancer, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
There is considerable evidence that turmeric consumption may have a protective effect against cancer progression. The purpose of this study is to examine the short-term effects of supplementation with a turmeric extract, Curcumin C3 Complex®, on biomarkers of head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Microgranular Curcumin C3 Complex®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jan 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with newly diagnosed head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx and have at least one accessible tumor
- Subjects willing to undergo tumor biopsies
- Subjects willing to refrain from nonsteroidal anti-inflammatory drugs (NSAIDS)
- Eastern Co-operative Oncology Group (ECOG) status of 0-3
- Absolute Neutrophil Count ≥ 1500/mm³, Hgb ≥ 10g/dl and Platelet count ≥ 150,000 mm3
- Adequate Renal Function: serum creatinine ≤ 1.5 × upper limit of normal (ULN). Adequate hepatic function: total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 × ULN
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- Signed and dated institutional review board approved informed consent form before any protocol specific procedures are performed
- Willingness of subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study and for 2 weeks after last dose of study drug
- No consumption of curcumin-rich foods to subject's knowledge within the previous 48 hours
- Age ≥ 18 years to ≤ 90 years
Who cannot join
- Subjects receiving anticoagulation therapy
- Known hypersensitivity to curry or black pepper
- Prior cancer therapy in the last 30 day
- Concurrent chemotherapy or radiation
- Severely immunocompromised subjects
- Subjects known to be HIV positive
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- any major illness that, in the investigator's judgment, will substantially increase the risk asociated with the subject's participation in the study
- Pregnant or nursing women
- Unwillingness or inability to comply with required study visits and procedures in this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
LSUHSC-Shreveport and Feist-Weiller Cancer Center
Shreveport, Louisiana, 71130
About this study
Official title: An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma
There is considerable evidence that turmeric consumption may have a protective effect against cancer progression. The purpose of this study is to examine the short-term effects of supplementation with a turmeric extract, Curcumin C3 Complex®, on biomarkers of head and neck squamous cell carcinoma (HNSCC).
Read the detailed description
This is an open label, exploratory biomarker trial of the food substances Curcumin C3 Complex® in subjects with newly diagnosed HNSCC. Curcumin, a novel safe nutritional interventional agent has exciting potential usage as a preventive/adjuvant agent, and prevents tumor formation by inhibiting an important molecular pathway that is shown to cause cancer progression, which we will test as a tumor marker in this clinical trial.
The primary objective is to evaluate biomarker response of HNSCC patients to the food substances Curcumin C3 Complex®. This will be done by comparing post-intervention values to baseline values. In addition, we will determine the levels of curcumin and its metabolites in tumor and adjacent tissue.
- Conditions
- Head and Neck Cancer
- Being tested
- Microgranular Curcumin C3 Complex®
- Keywords
- cancer
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microgranular Curcumin C3 Complex®Drug
4 grams twice daily for 21-28 days
| Study group | Role | What they receive |
|---|---|---|
| Microgranular Curcumin | Experimental | Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day Receives: Drug: Microgranular Curcumin C3 Complex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tissue biomarkers
Change in tissue levels, between pre- and post-treatment biopsy
Measured: 21-28 days
Pharmacokinetics of microgranular curcumin
Determine whether biologically active levels of curcumin can be achieved in head and neck tumors
Measured: 21-28 days
Secondary outcomes (1)
Ease of ingestion
Determine if microgranular curcumin can be easily ingested
Measured: 21-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Collaborators
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Cherie Ann Nathan, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Cherie-Ann O Nathan, MD, FACS, Principal investigator, LSUHSC-Shreveport and Feist-Weiller Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160302
- Sponsor's protocol ID
- H08-081
- Other IDs
- 1R21CA137545-01A2, FWCC
- Status last verified
- Mar 2016
- First submitted
- 8 Jul 2010
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01160302
- Acronym / sponsor ID
- H08-081
- Conditions
- Head and Neck Cancer
- Keywords
- cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Collaborators
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences, National Cancer Institute (NCI)
- Study start
- Jun 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is considerable evidence that turmeric consumption may have a protective effect against cancer progression. The purpose of this study is to examine the short-term effects of supplementation with a turmeric extract, Curcumin C3 Complex®, on biomarkers of head and neck squamous cell carcinoma (HNSCC).
Detailed description
This is an open label, exploratory biomarker trial of the food substances Curcumin C3 Complex® in subjects with newly diagnosed HNSCC. Curcumin, a novel safe nutritional interventional agent has exciting potential usage as a preventive/adjuvant agent, and prevents tumor formation by inhibiting an important molecular pathway that is shown to cause cancer progression, which we will test as a tumor marker in this clinical trial.
The primary objective is to evaluate biomarker response of HNSCC patients to the food substances Curcumin C3 Complex®. This will be done by comparing post-intervention values to baseline values. In addition, we will determine the levels of curcumin and its metabolites in tumor and adjacent tissue.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microgranular Curcumin | Experimental | Drug: Microgranular Curcumin C3 Complex®Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with newly diagnosed head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx and have at least one accessible tumor
- Subjects willing to undergo tumor biopsies
- Subjects willing to refrain from nonsteroidal anti-inflammatory drugs (NSAIDS)
- Eastern Co-operative Oncology Group (ECOG) status of 0-3
- Absolute Neutrophil Count ≥ 1500/mm³, Hgb ≥ 10g/dl and Platelet count ≥ 150,000 mm3
Key exclusion criteria (9 listed)
- Subjects receiving anticoagulation therapy
- Known hypersensitivity to curry or black pepper
- Prior cancer therapy in the last 30 day
- Concurrent chemotherapy or radiation
- Severely immunocompromised subjects
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 |
|---|---|---|
| Microgranular Curcumin C3 Complex®4 grams twice daily for 21-28 days | Drug | Microgranular Curcumin |
Primary outcome
Change in tissue biomarkers
Time frame: 21-28 days
Change in tissue levels, between pre- and post-treatment biopsy
Pharmacokinetics of microgranular curcumin
Time frame: 21-28 days
Determine whether biologically active levels of curcumin can be achieved in head and neck tumors
1 secondary outcome
Ease of ingestion
Time frame: 21-28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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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.
Cherie-Ann O Nathan, MD, FACS principal investigator
LSUHSC-Shreveport and Feist-Weiller Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Microgranular Curcumin C3 Complex® in people with Head and Neck Cancer, run by Louisiana State University Health Sciences Center Shreveport 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 2 Mar 2016. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in tissue biomarkers (time frame: 21-28 days). The study lists 2 primary outcomes in all. 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 2 Mar 2016.