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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
Enrollment 35
Recruitment Details 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  
Arm/Group Title Curcumin C3 Complex Placebo
Hide Arm/Group Description Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks). Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Period Title: Overall Study
Started 17 [1] 18 [2]
Completed 14 16
Not Completed 3 2
Reason Not Completed
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.
Arm/Group Title Curcumin C3 Complex Placebo Total
Hide Arm/Group Description Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks). Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks). Total of all reporting groups
Overall Number of Baseline Participants 17 18 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  88.2%
13
  72.2%
28
  80.0%
>=65 years
2
  11.8%
5
  27.8%
7
  20.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 18 participants 35 participants
50.4  (9.51) 53.7  (7.55) 51.8  (8.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 35 participants
Female
17
 100.0%
18
 100.0%
35
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 18 participants 35 participants
17 18 35
1.Primary Outcome
Title Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients
Hide Description The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.
Time Frame 4-7 weeks (prescribed course of radiation)
Hide Outcome Measure Data
Hide Analysis Population Description
We used all 30 participants that fully completed the trial in all of our analyses.
Arm/Group Title Curcumin C3 Complex Placebo
Hide Arm/Group Description:
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (0.994) 3.4  (0.554)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin C3 Complex, Placebo
Comments Hypothesis: The mean RDS for curcumin group is significantly different (i.e., lower) than mean RDS of placebo group at end of radiation treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0077
Comments [Not Specified]
Method Standard pooled variances t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7991
Confidence Interval (2-Sided) 95%
-1.3693 to -0.2289
Parameter Dispersion
Type: Standard Deviation
Value: 0.7606
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Moist Desquamation at Radiation Treatment Site
Hide Description The presence of moist desquamation at the end of radiation treatment was examined between curcumin and placebo treatment groups. We compared the number of participants (or percentage) with moist desquamation between each treatment group.
Time Frame 4-7 weeks (prescribed course of radiation)
Hide Outcome Measure Data
Hide Analysis Population Description
All 30 participants who completed the trial were used in all analyses.
Arm/Group Title Curcumin C3 Complex Placebo
Hide Arm/Group Description:
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Overall Number of Participants Analyzed 14 16
Measure Type: Number
Unit of Measure: participants
4 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin C3 Complex, Placebo
Comments Hypothesis: The presence of moist desquamation significantly differed between the curcumin group and the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Redness at Radiation Treatment Site
Hide Description Redness at radiation treatment site was measured using a CR-400 Colorimeter (Konica Minolta). The colorimeter uses the L*a*b* color scale. We used a* values (redness) which range from 0.0 to 20.0. The lower the number value, the lower amount of redness. Therefore, high number values represent large amounts of redness.
Time Frame 4-7 weeks (prescribed course of radiation)
Hide Outcome Measure Data
Hide Analysis Population Description
The 30 participants that fullt completed the trial were used in these analyses.
Arm/Group Title Curcumin C3 Complex Placebo
Hide Arm/Group Description:
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: units on a scale (0.0 to 20.0)
4.52  (2.81) 6.06  (2.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin C3 Complex, Placebo
Comments Hypothesis: There is a significant difference in mean redness (i.e., mean a* number value) between the curcumin and placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Pain at Radiation Treatment Site
Hide Description The McGill Pain Questionnaire-Short Form (MPQ-SF) was used to determine the participants pain at treatment site. The MPQ-SF contains three subscales: affective pain, sensory pain, and perceived pain. This outcome measure compared the total pain score (range 0 to 50)and subscale scores (sensory subscale range 0 to 33; affective subscale range 0 to 12; perceived pain subscale 0 to 5) at the end of radiation therapy between the two treatment arms.
Time Frame 4-7 weeks (prescribed course of radiation)
Hide Outcome Measure Data
Hide Analysis Population Description
All 30 participants that fully completed the trial were used in these analyses.
Arm/Group Title Curcumin C3 Complex Placebo
Hide Arm/Group Description:
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
MPQ Total Score 5.71  (4.27) 3.50  (3.43)
Sensory Pain Subscale 4.07  (3.29) 2.25  (2.32)
Affective Pain Subscale 0.50  (0.76) 0.50  (0.82)
Perceived Pain Intensity 1.14  (0.77) 0.88  (0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin C3 Complex, Placebo
Comments Hypothesis: There is a significant difference in mean MPQ pain scores between the curcumin and placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.685
Confidence Interval (2-Sided) 95%
-1.059 to 4.428
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Curcumin C3 Complex, Placebo
Comments Hypothesis: There is a significant difference in mean sensory subscale pain scores between curcumin and placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.152
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-0.6 to 3.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Curcumin C3 Complex, Placebo
Comments Hypohesis: There is a signifcant difference in affective subscale pain scores between curcumin and placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.700
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.7 to 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Curcumin C3 Complex, Placebo
Comments Hypothesis: There is a significant difference in mean perceived pain scores between curcumin and placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.559
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.4 to 0.7
Estimation Comments [Not Specified]
Time Frame The last assessment for every participant was 6 month after completion of radiation therapy. Symptom Inventory was used to monitor side effects during radiation therapy as well as in follow-up assessments. No adverse events occurred during this study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Curcumin C3 Complex Placebo
Hide Arm/Group Description Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks). Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
All-Cause Mortality
Curcumin C3 Complex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Curcumin C3 Complex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Curcumin C3 Complex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
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.
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
Layout table for Results Point of Contact information
Name/Title: Julie L Ryan, PhD, MPH (PI)
Organization: University of Rochester Medical Center
Phone: 585-276-3862
EMail: julie_ryan@urmc.rochester.edu
Layout table for additonal information
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