Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Wounds and Injuries

Dermatitis

Breast Neoplasms

Radiodermatitis

Breast Diseases

Skin Diseases

Radiation Injuries

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Curcumin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

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).

Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)

Curcumin C3 Complex

Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)

Placebo

Julie L Ryan, PhD, MPH

Alice P Pentland, MD

Marilyn Ling, MD

Ionizing radiation is a toxic agent and widely accepted form of treatment for various types of cancer. Despite advances in medical technology, radiation therapy still causes severe early and late skin effects. Radiation-induced dermatitis occurs in approximately 80% of patients. Important consequences of radiation-induced dermatitis include impairment of the quality of a patient's life due to pain and premature interruption of radiation treatment, which in turn, may be impair good local control of disease. The biological pathways responsible for acute radiation-induced dermatitis remain unclear. Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness. The aim of this randomized, double-blind, placebo-controlled pilot study is to assess the effectiveness of curcumin for the prevention of acute radiation-induced dermatitis during postoperative radiotherapy for breast cancer. We hypothesize that curcumin, a natural phenolic compound found in both turmeric and curry powders, can prevent or alleviate radiation-induced skin reactions in breast cancer patients receiving radiotherapy.

Specifically, this clinical pilot study will develop data necessary to calculate a sample size for a larger study to be conducted through the National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) mechanism. Specifically, this pilot project will investigate: 1) if curcumin can prevent or alleviate radiation-induced skin reactions in cancer patients receiving radiotherapy and 2) if skin pigmentation, as well as pain and psychophysiological factors, can predict the severity of radiation-induced dermatitis. Potential future research studies may be conducted to identify the biological mechanisms involved in radiation-induced dermatitis and the radioprotective function of curcumin.

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

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.

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.

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.

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.

University of Rochester

Assistant Professor

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

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.

Julie L Ryan, PhD, MPH (PI)

Hypothesis: The mean RDS for curcumin group is significantly different (i.e., lower) than mean RDS of placebo group at end of radiation treatment.

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).

We used all 30 participants that fully completed the trial in all of our analyses.

Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients

Hypothesis: The presence of moist desquamation significantly differed between the curcumin group and the placebo group.

All 30 participants who completed the trial were used in all analyses.

Moist Desquamation at Radiation Treatment Site

Hypothesis: There is a significant difference in mean redness (i.e., mean a\* number value) between the curcumin and placebo groups.

The 30 participants that fullt completed the trial were used in these analyses.

Redness at Radiation Treatment Site

Hypothesis: There is a significant difference in mean MPQ pain scores between the curcumin and placebo groups.

Hypothesis: There is a significant difference in mean sensory subscale pain scores between curcumin and placebo groups.

Hypohesis: There is a signifcant difference in affective subscale pain scores between curcumin and placebo groups.

Hypothesis: There is a significant difference in mean perceived pain scores between curcumin and placebo groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients	NCT01042938	Breast Cancer	Curcumin C3 Com... Placebo	21 Years -	University of Rochester
Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients	NCT01042938	Breast Cancer	Curcumin C3 Com... Placebo	21 Years -	University of Rochester
Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients	NCT01042938	Breast Cancer	Curcumin C3 Com... Placebo	21 Years -	University of Rochester

Spots Global Cancer Trial Database for radiation dermatitis in breast cancer patients