Trial Outcomes & Findings for Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients (NCT NCT01042938)
NCT ID: NCT01042938
Last Updated: 2012-06-25
Results Overview
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.
COMPLETED
PHASE2
35 participants
4-7 weeks (prescribed course of radiation)
2012-06-25
Participant Flow
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.
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Ineligible: RTOG study conflict
|
1
|
0
|
Baseline Characteristics
Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Curcumin C3 Complex
n=17 Participants
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks).
|
Placebo
n=18 Participants
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks).
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
50.4 years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 7.55 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-7 weeks (prescribed course of radiation)Population: We used all 30 participants that fully completed the trial in all of our analyses.
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.
Outcome measures
| Measure |
Curcumin C3 Complex
n=14 Participants
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (\~4-7 weeks).
|
Placebo
n=16 Participants
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(\~4-7 weeks).
|
|---|---|---|
|
Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients
|
2.6 units on a scale
Standard Deviation 0.994 • Interval 2.06 to 3.15
|
3.4 units on a scale
Standard Deviation 0.554 • Interval 3.11 to 3.7
|
SECONDARY outcome
Timeframe: 4-7 weeks (prescribed course of radiation)Population: All 30 participants who completed the trial were used in all analyses.
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.
Outcome measures
| Measure |
Curcumin C3 Complex
n=14 Participants
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (\~4-7 weeks).
|
Placebo
n=16 Participants
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(\~4-7 weeks).
|
|---|---|---|
|
Moist Desquamation at Radiation Treatment Site
|
4 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 4-7 weeks (prescribed course of radiation)Population: The 30 participants that fullt completed the trial were used in these analyses.
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.
Outcome measures
| Measure |
Curcumin C3 Complex
n=14 Participants
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (\~4-7 weeks).
|
Placebo
n=16 Participants
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(\~4-7 weeks).
|
|---|---|---|
|
Redness at Radiation Treatment Site
|
4.52 units on a scale (0.0 to 20.0)
Standard Deviation 2.81
|
6.06 units on a scale (0.0 to 20.0)
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: 4-7 weeks (prescribed course of radiation)Population: All 30 participants that fully completed the trial were used in these analyses.
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.
Outcome measures
| Measure |
Curcumin C3 Complex
n=14 Participants
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (\~4-7 weeks).
|
Placebo
n=16 Participants
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(\~4-7 weeks).
|
|---|---|---|
|
Pain at Radiation Treatment Site
MPQ Total Score
|
5.71 units on a scale
Standard Deviation 4.27
|
3.50 units on a scale
Standard Deviation 3.43
|
|
Pain at Radiation Treatment Site
Sensory Pain Subscale
|
4.07 units on a scale
Standard Deviation 3.29
|
2.25 units on a scale
Standard Deviation 2.32
|
|
Pain at Radiation Treatment Site
Affective Pain Subscale
|
0.50 units on a scale
Standard Deviation 0.76
|
0.50 units on a scale
Standard Deviation 0.82
|
|
Pain at Radiation Treatment Site
Perceived Pain Intensity
|
1.14 units on a scale
Standard Deviation 0.77
|
0.88 units on a scale
Standard Deviation 0.62
|
Adverse Events
Curcumin C3 Complex
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Julie L Ryan, PhD, MPH (PI)
University of Rochester Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place