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Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01042938
Recruitment Status : Completed
First Posted : January 6, 2010
Results First Posted : June 20, 2012
Last Update Posted : June 25, 2012
Sponsor:
Information provided by (Responsible Party):
Julie Ryan, University of Rochester

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Curcumin C3 Complex
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment for this trial began January 18, 2008 and ended on January 27, 2010. All patients were recruited and treated at the University of Rochester Cancer Center. Of the 213 breast cancer patients prescribed radiation therapy during this timeframe, 67 patients were approached for particiaption in the trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Curcumin C3 Complex Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Placebo Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).

Participant Flow:   Overall Study
    Curcumin C3 Complex   Placebo
STARTED   17 [1]   18 [2] 
COMPLETED   14   16 
NOT COMPLETED   3   2 
Withdrawal by Subject                1                1 
Protocol Violation                1                1 
Ineligible: RTOG study conflict                1                0 
[1] 1 withdrew before radiation; 1 ineligible due to other clinical trial; 1 non-compliance.
[2] 1 withdrew before radiation; 1 non-compliance.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Curcumin C3 Complex Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Placebo Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Total Total of all reporting groups

Baseline Measures
   Curcumin C3 Complex   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   18   35 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   15   13   28 
>=65 years   2   5   7 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.4  (9.51)   53.7  (7.55)   51.8  (8.21) 
Gender 
[Units: Participants]
     
Female   17   18   35 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   17   18   35 


  Outcome Measures

1.  Primary:   Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients   [ Time Frame: 4-7 weeks (prescribed course of radiation) ]

2.  Secondary:   Moist Desquamation at Radiation Treatment Site   [ Time Frame: 4-7 weeks (prescribed course of radiation) ]

3.  Secondary:   Redness at Radiation Treatment Site   [ Time Frame: 4-7 weeks (prescribed course of radiation) ]

4.  Secondary:   Pain at Radiation Treatment Site   [ Time Frame: 4-7 weeks (prescribed course of radiation) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The primary limitation of this clinical study is the small sample size. This study was a pilot trial to generate an effect and sample size for a larger confirmatory trial. We accrued patients to this study until we had 30 fully evaluable patients.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Julie L Ryan, PhD, MPH (PI)
Organization: University of Rochester Medical Center
phone: 585-276-3862
e-mail: julie_ryan@urmc.rochester.edu



Responsible Party: Julie Ryan, University of Rochester
ClinicalTrials.gov Identifier: NCT01042938     History of Changes
Other Study ID Numbers: URCC1106
5KL2RR024136-03 ( U.S. NIH Grant/Contract )
05-238-80 ( Other Grant/Funding Number: Dermatology Foundation )
First Submitted: January 4, 2010
First Posted: January 6, 2010
Results First Submitted: January 26, 2012
Results First Posted: June 20, 2012
Last Update Posted: June 25, 2012