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

Phase 2
21 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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.

Inclusion Criteria:

- Female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred
for post-operative radiotherapy without concurrent chemotherapy.

- Participants must be at least 21 years of age.

- Participants must not be pregnant.

- Participants can be from any racial or ethnic origin.

- Breast adenocarcinoma could have been treated by either lumpectomy or mastectomy with
or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.

- Participants with in situ breast cancer are eligible.

- Participants who are prescribed concurrent hormone treatment with radiation treatment
are eligible.

- Participants must be scheduled to receive five sessions of radiation therapy per week
(1 session per day) for at least four weeks using standard (1.8-2.0 Gy per session)or
Canadian (2.2-2.5 Gy per session)irradiation fractionation.

- A time period of three weeks must elapse after chemotherapy and surgery before
beginning the study.

- The total dose prescribed to the whole breast should be 50 Gy or greater.

- Participants must be able to understand English and able to complete assessment forms
(all assessment forms are in English).

- Participants must be able to swallow medication.

- Topical skin agents, e.g., Aquaphor, Cetaphil, or other emollients, are allowed
either PRN or prophylactically.

- Participant must give informed consent.

Exclusion Criteria:

- Patients with bilateral breast cancer are not eligible.

- Patients who have had previous radiation therapy to the breast or chest are not

- Patients who are prescribed chemotherapy concurrently with radiation treatment are
not eligible.

- Patients who will be receiving treatment with Herceptin (trastuzumab),
anti-coagulants, or anti-human epidermal growth factor receptor (EGFR) drugs, e.g.
Iressa (gefitinib), Erbitux (cetuximab, C225), concurrently with their radiation
therapy are not eligible.

- Patients cannot have had breast reconstructions, implants, and/or expanders.

- Patients with known radiosensitivity syndromes (e.g., Ataxia-telangiectasia) are not

- Patients with collagen vascular disease, vasculitis, unhealed surgical sites, or
breast infections are not eligible.

- Patients whose baseline blood tests meet the following criteria are not eligible:
greater than or equal to Grade 2 change Hemoglobin (i.e., 25% decrease from
baseline); greater than or equal to Grade 1 change in Platelets (i.e., less than
75,000/mm3); greater than or equal to Grade 2 change in PT and PTT(i.e., 1.5-2x upper
level normal (ULN)); greater than or equal to Grade 1 change in AST, ALT (i.e.,
greater than 2.5x ULN); greater than or equal to Grade 1 change in Bilirubin (i.e.,
greater than 1.5x ULN); greater than or equal to Grade 1 change in Creatinine (i.e.,
greater than 2x ULN).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients

Outcome 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.

Outcome Time Frame:

4-7 weeks (prescribed course of radiation)

Safety Issue:


Principal Investigator

Julie L Ryan, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester Medical Center & Wilmot Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

April 2011

Related Keywords:

  • Breast Cancer
  • Radiation dermatitis in breast cancer patients
  • Breast Neoplasms
  • Dermatitis
  • Radiodermatitis



University of Rochester Medical Center & Wilmot Cancer Center Rochester, New York  14642