2004-11
2014-04
2014-04
50
NCT00094445
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
INTERVENTIONAL
Trial of Curcumin in Advanced Pancreatic Cancer
The goal of this clinical research study is to learn if treatment with curcumin can help shrink or slow the growth of pancreatic cancers. The effect of curcumin on the way pancreatic cancer cells function and the safety of treatment with curcumin will also be studied.
Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. During this study, you will receive much higher doses of curcumin than can be obtained from the diet. During the study, you will receive curcumin by mouth every day. You will be required to take up to 16 pills per day each morning. Every 8-week period you take curcumin is considered a Ȭourse" of treatment. The number of courses you receive depends on how you are responding to treatment. You can continue treatment as long as the disease does not get worse. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you. You will be given a questionnaire to complete at the beginning of the study and once a week while you are on therapy to help the medical staff understand how the different symptoms from your disease are affecting you. This questionnaire, which should take about 5 minutes to complete, can be done over the telephone or with the help of one of the study staff during your visits. At the end of each course of treatment (every 8 weeks), you will have a physical exam and the tumor will be re-evaluated using CT scans and/or blood (about 2 tablespoons) tests. This is an investigational study. Curcumin is a commercially available substance, which is commonly used as a food additive. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2004-10-18 | 2020-08-13 | 2020-08-13 |
2004-10-18 | 2020-08-13 | 2020-08-28 |
2004-10-19 | 2020-08-28 | 2020-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Curcumin Oral curcumin daily for eight weeks, starting dose 8 gm per day. | DRUG: Curcumin
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Six-Month Participant Survival | Number of participants followed from baseline (date of randomization) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. | Baseline to 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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