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Trial of Curcumin in Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00094445
Recruitment Status : Completed
First Posted : October 19, 2004
Results First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Collaborator:
Sabinsa Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Neoplasms
Adenocarcinoma
Intervention Drug: Curcumin
Enrollment 50
Recruitment Details Recruitment Period: November 12, 2004 to November 11, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details 1 participant did not receive treatment due to screen failure, patient withdrew the consent
Arm/Group Title Curcumin
Hide Arm/Group Description Oral curcumin daily for eight weeks, starting dose 8 gm per day.
Period Title: Overall Study
Started 50
Completed 44
Not Completed 6
Reason Not Completed
Withdrawal by Subject             3
Lost to Follow-up             1
Progressive Disease             2
Arm/Group Title Curcumin
Hide Arm/Group Description Oral curcumin daily for eight weeks, starting dose 8 gm per day.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants
65
(40 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
28
  56.0%
Male
22
  44.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   6.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
47
  94.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
4
   8.0%
Not Hispanic or Latino
46
  92.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Six-Month Participant Survival
Hide Description 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.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin
Hide Arm/Group Description:
Oral curcumin daily for eight weeks, starting dose 8 gm per day.
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
7
  15.9%
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Curcumin
Hide Arm/Group Description Oral curcumin daily for eight weeks, starting dose 8 gm per day.
All-Cause Mortality
Curcumin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Curcumin
Affected / at Risk (%)
Total   9/44 (20.45%) 
Cardiac disorders   
Chest pain  1  1/44 (2.27%) 
Multiple pulmonary emboli  1  1/44 (2.27%) 
atrial fibrillation  1  1/44 (2.27%) 
atrial flutter  1  1/44 (2.27%) 
Gastrointestinal disorders   
GI hemmorhage  1  1/44 (2.27%) 
chronic cancer progression  1  1/44 (2.27%) 
abdomen pain  1  2/44 (4.55%) 
metastasis  1  1/44 (2.27%) 
ascites  1  1/44 (2.27%) 
constipation  1  1/44 (2.27%) 
vomiting  1  1/44 (2.27%) 
Chronic colocutaneous fistula  1  1/44 (2.27%) 
abdominal wall abscess  1  1/44 (2.27%) 
indigestion  1  1/44 (2.27%) 
General disorders   
weakness  1  1/44 (2.27%) 
dehydration  1  1/44 (2.27%) 
non-neutropenic fever  1  1/44 (2.27%) 
Pain  1  1/44 (2.27%) 
Infections and infestations   
infection  1  1/44 (2.27%) 
Metabolism and nutrition disorders   
anorexia  1  3/44 (6.82%) 
Musculoskeletal and connective tissue disorders   
musculoskeletal  1  1/44 (2.27%) 
Nervous system disorders   
slurred speech  1  1/44 (2.27%) 
confusion  1  1/44 (2.27%) 
mood alteration  1  1/44 (2.27%) 
Renal and urinary disorders   
acute renal failure  1  1/44 (2.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Curcumin
Affected / at Risk (%)
Total   6/44 (13.64%) 
Gastrointestinal disorders   
vomiting  1  2/44 (4.55%) 
nausea  1  2/44 (4.55%) 
abdomen  1  1/44 (2.27%) 
General disorders   
Fatigue  1  1/44 (2.27%) 
Nervous system disorders   
depression  1  1/44 (2.27%) 
Skin and subcutaneous tissue disorders   
edema  1  4/44 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vivek Subbiah, MD / Assistant Professor, Investigational Cancer Therapeutics
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-563-0393
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00094445    
Other Study ID Numbers: ID03-0009
1R21CA104337 ( U.S. NIH Grant/Contract )
NCI-2012-01309 ( Registry Identifier: NCI CTRP )
First Submitted: October 18, 2004
First Posted: October 19, 2004
Results First Submitted: August 13, 2020
Results First Posted: August 28, 2020
Last Update Posted: August 28, 2020