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Oral Curcumin for Radiation Dermatitis

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Julie Ryan, University of Rochester
ClinicalTrials.gov Identifier:
NCT01246973
First received: November 22, 2010
Last updated: February 8, 2016
Last verified: February 2016
Results First Received: January 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Radiation-induced Dermatitis
Interventions: Drug: Curcumin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Curcumin

4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week

Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week

Placebo

4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week


Participant Flow:   Overall Study
    Curcumin     Placebo  
STARTED     344     342  
COMPLETED     283     295  
NOT COMPLETED     61     47  
unspecified                 38                 25  
Adverse Event                 16                 9  
Withdrawal by Subject                 7                 13  



  Baseline Characteristics
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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

4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week

Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week

Placebo

4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Total Total of all reporting groups

Baseline Measures
    Curcumin     Placebo     Total  
Number of Participants  
[units: participants]
  344     342     686  
Age  
[units: years]
Mean (Standard Deviation)
  57.6  (0.6)     57.7  (0.5)     57.6  (0.4)  
Gender  
[units: participants]
     
Female     344     342     686  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     6     7     13  
Not Hispanic or Latino     264     237     501  
Unknown or Not Reported     74     98     172  
Race/Ethnicity, Customized  
[units: participants]
     
White/caucasian     307     293     600  
black/african american     29     30     59  
other race     8     19     27  
Region of Enrollment  
[units: participants]
     
United States     344     342     686  



  Outcome Measures
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1.  Primary:   Mean Radiation Dermatitis Severity Score   [ Time Frame: 6 weeks ]

2.  Secondary:   Percentage of Subjects With Moist Desquamation   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Julie Ryan
Organization: University of Rochester
phone: 585-276-3862
e-mail: julie_ryan@urmc.rochester.edu



Responsible Party: Julie Ryan, University of Rochester
ClinicalTrials.gov Identifier: NCT01246973     History of Changes
Obsolete Identifiers: NCT01238198
Other Study ID Numbers: URCC 10054
URCC 09005 ( Other Identifier: NCI )
U10CA037420 ( US NIH Grant/Contract Award Number )
URCC 10054 ( Other Identifier: University of Rochester )
Study First Received: November 22, 2010
Results First Received: January 5, 2016
Last Updated: February 8, 2016
Health Authority: United States: Food and Drug Administration