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Randomized Controlled Trial
. 2013 Jul;180(1):34-43.
doi: 10.1667/RR3255.1. Epub 2013 Jun 7.

Curcumin for Radiation Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Thirty Breast Cancer Patients

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Free PMC article
Randomized Controlled Trial

Curcumin for Radiation Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Thirty Breast Cancer Patients

Julie L Ryan et al. Radiat Res. .
Free PMC article

Abstract

Radiation dermatitis occurs in approximately 95% of patients receiving radiotherapy (RT) for breast cancer. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the ability of curcumin to reduce radiation dermatitis severity in 30 breast cancer patients. Eligible patients were adult females with noninflammatory breast cancer or carcinoma in situ prescribed RT without concurrent chemotherapy. Randomized patients took 2.0 grams of curcumin or placebo orally three times per day (i.e., 6.0 grams daily) throughout their course of RT. Weekly assessments included Radiation Dermatitis Severity (RDS) score, presence of moist desquamation, redness measurement, McGill Pain Questionnaire-Short Form and Symptom Inventory questionnaire. The 30 evaluable patients were primarily white (90%) and had a mean age of 58.1 years. Standard pooled variances t test showed that curcumin reduced RDS at end of treatment compared to placebo (mean RDS = 2.6 vs. 3.4; P = 0.008). Fisher's exact test revealed that fewer curcumin-treated patients had moist desquamation (28.6% vs. 87.5%; P = 0.002). No significant differences were observed between arms for demographics, compliance, radiation skin dose, redness, pain or symptoms. In conclusion, oral curcumin, 6.0 g daily during radiotherapy, reduced the severity of radiation dermatitis in breast cancer patients.

Figures

FIG. 1
FIG. 1
Radiation Dermatitis Severity (RDS) scoring. Panel A: The severity of radiation dermatitis was measured using this scoring system, range 0.0 to 4.0 at increments of 0.5. The RDS score incorporates changes in redness, pigment, texture and integrity of the skin. Panel B: Digital images of portraying the appearance of various RDS scores (1.0, 2.0, 3.0 and 4.0 from left to right) in fair (top) and darkly pigmented (bottom) skin.
FIG. 2
FIG. 2
Consort diagram. This diagram documents the patient flow for the clinical trial. Only 93/213 (43.7%) of patients prescribed radiation therapy for breast cancer were eligible for this trial. Of the patients approached for participation, 35/67 (52.2%) consented. The withdrawal rate for the study was 5/35 (14.2%).
FIG. 3
FIG. 3
Curcumin reduced radiation dermatitis severity and presence of moist desquamation. Panel A: Line graph plotting the mean RDS scores by week of RT for curcumin and placebo arms. The two arms are similar for week 1 to week 4, but then diverge from week 5 to week 7. Panel B: Standard pooled variances t test showed that the curcumin arm had significantly lower RDS scores at the end of RT compared to the placebo. Repeated measures analyses demonstrated that the Arm*Week interaction and the total Arm effect (Arm + Arm*Week) were highly significant. Panel C: Fisher’s exact test showed that fewer patients in the curcumin arm had the presence of moist desquamation at the end of RT compared to the placebo arm.
FIG. 4
FIG. 4
Mean change scores for pain items from Symptom Inventory (SI) and MPQ-SF. The forest plot presents the mean change scores (EndRT-Baseline) for the 2 pain items on the SI (“pain at RT site” and “other pain”) and the 15 different pain items, total MPQ, and Subscale scores on the MPQ-SF. Error bars represent standard deviation. Individual MPQ-SF pain items, “gnawing,” “aching” and “splitting” showed slightly higher pain at EndRT in curcumin patients compared to placebo. However, no differences were observed in total or subscale MPQ-SF scores or in the 2 SI items.
FIG. 5
FIG. 5
Symptom severity mean change scores. The forest plot presents the mean change severity scores for the other 17 symptoms on the Symptom Inventory. Error bars represent standard deviation. ANCOVA analyses did not reveal any significant findings. However, t test on mean change scores did show a difference in “upset/depressed” between curcumin and placebo arms. These results were due to the high baseline level of “upset/depressed” in the curcumin arm compared to placebo, which was accounted for in the ANCOVA.

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