Trial Outcomes & Findings for Trial of Curcumin in Advanced Pancreatic Cancer (NCT NCT00094445)
NCT ID: NCT00094445
Last Updated: 2020-08-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2020-08-28
Participant Flow
Recruitment Period: November 12, 2004 to November 11, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
1 participant did not receive treatment due to screen failure, patient withdrew the consent
Participant milestones
| Measure |
Curcumin
Oral curcumin daily for eight weeks, starting dose 8 gm per day.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Curcumin
Oral curcumin daily for eight weeks, starting dose 8 gm per day.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Progressive Disease
|
2
|
Baseline Characteristics
Trial of Curcumin in Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Curcumin
n=50 Participants
Oral curcumin daily for eight weeks, starting dose 8 gm per day.
|
|---|---|
|
Age, Continuous
|
65 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsNumber 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.
Outcome measures
| Measure |
Curcumin
n=44 Participants
Oral curcumin daily for eight weeks, starting dose 8 gm per day.
|
|---|---|
|
Six-Month Participant Survival
|
7 Participants
|
Adverse Events
Curcumin
Serious events: 9 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Curcumin
n=44 participants at risk
Oral curcumin daily for eight weeks, starting dose 8 gm per day.
|
|---|---|
|
Gastrointestinal disorders
GI hemmorhage
|
2.3%
1/44 • 3 years
|
|
Cardiac disorders
Chest pain
|
2.3%
1/44 • 3 years
|
|
Cardiac disorders
Multiple pulmonary emboli
|
2.3%
1/44 • 3 years
|
|
Gastrointestinal disorders
chronic cancer progression
|
2.3%
1/44 • 3 years
|
|
Gastrointestinal disorders
abdomen pain
|
4.5%
2/44 • 3 years
|
|
Renal and urinary disorders
acute renal failure
|
2.3%
1/44 • 3 years
|
|
Gastrointestinal disorders
metastasis
|
2.3%
1/44 • 3 years
|
|
General disorders
weakness
|
2.3%
1/44 • 3 years
|
|
General disorders
dehydration
|
2.3%
1/44 • 3 years
|
|
Nervous system disorders
slurred speech
|
2.3%
1/44 • 3 years
|
|
Nervous system disorders
confusion
|
2.3%
1/44 • 3 years
|
|
Metabolism and nutrition disorders
anorexia
|
6.8%
3/44 • 3 years
|
|
General disorders
non-neutropenic fever
|
2.3%
1/44 • 3 years
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
2.3%
1/44 • 3 years
|
|
Gastrointestinal disorders
ascites
|
2.3%
1/44 • 3 years
|
|
Gastrointestinal disorders
constipation
|
2.3%
1/44 • 3 years
|
|
Nervous system disorders
mood alteration
|
2.3%
1/44 • 3 years
|
|
Gastrointestinal disorders
vomiting
|
2.3%
1/44 • 3 years
|
|
General disorders
Pain
|
2.3%
1/44 • 3 years
|
|
Gastrointestinal disorders
Chronic colocutaneous fistula
|
2.3%
1/44 • 3 years
|
|
Gastrointestinal disorders
abdominal wall abscess
|
2.3%
1/44 • 3 years
|
|
Infections and infestations
infection
|
2.3%
1/44 • 3 years
|
|
Cardiac disorders
atrial fibrillation
|
2.3%
1/44 • 3 years
|
|
Cardiac disorders
atrial flutter
|
2.3%
1/44 • 3 years
|
|
Gastrointestinal disorders
indigestion
|
2.3%
1/44 • 3 years
|
Other adverse events
| Measure |
Curcumin
n=44 participants at risk
Oral curcumin daily for eight weeks, starting dose 8 gm per day.
|
|---|---|
|
Skin and subcutaneous tissue disorders
edema
|
9.1%
4/44 • 3 years
|
|
Gastrointestinal disorders
vomiting
|
4.5%
2/44 • 3 years
|
|
Gastrointestinal disorders
nausea
|
4.5%
2/44 • 3 years
|
|
Gastrointestinal disorders
abdomen
|
2.3%
1/44 • 3 years
|
|
Nervous system disorders
depression
|
2.3%
1/44 • 3 years
|
|
General disorders
Fatigue
|
2.3%
1/44 • 3 years
|
Additional Information
Vivek Subbiah, MD / Assistant Professor, Investigational Cancer Therapeutics
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-563-0393
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place