Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer

PRIMARY OBJECTIVE:

I. To investigate the effectiveness of Curcumin gel (curcumin-based gel) or HPR Plus™ in
reducing radiation dermatitis in breast cancer patients.

Inclusion Criteria:

- Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ

- Subjects must be prescribed and scheduled for "conventional fractionated" RT without
concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are
permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular
nodes, axillary nodes, etc) as part of their prescribed radiation therapy are
permitted; conventional fractionated radiation therapy regimens eligible for study are
described below:

- Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor
bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy

- Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed =
whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy

- Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed =
whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy

- Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed =
whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy

- Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole
breast +/- boost: 25 Gy; lymph nodes: 25 Gy

- Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole
breast +/- boost: 36 Gy; lymph nodes: 28 Gy

- Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole
breast +/- boost: 25 Gy; lymph nodes: 25 Gy

- Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole
breast +/- boost: 36 Gy; lymph nodes: 28 Gy

- Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT;
(NOTE: surgery is not required for eligibility)

- Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is
required between end of chemotherapy and start of RT

- Subjects may be currently prescribed hormone treatment or Herceptin therapy

- Subjects must be able to read, speak, and understand English

- Subjects must have the ability to understand and the willingness to sign a written
informed consent document

- Subjects must agree to not use any other topical agents on skin in the radiation
treatment area during the course of this trial; subjects should only use topical
agents for the study (i.e., topical intervention or standard care agents) supplied by
the study personnel and/or treating physician

Exclusion Criteria:

- Pregnant females are ineligible; all subjects of childbearing potential will be asked
if they are pregnant or could be pregnant; the patient must respond "no" to continue
with radiation and to participate in this clinical study

- Subjects with bilateral breast cancer are not eligible

- Subjects receiving the short-course fractionation radiation therapy (i.e., 16 sessions
or 20 sessions at 2.4 to 2.6 Gy fractions per session, with or without boost)

- Subject is currently on anti-EGFR (human epidermal growth factor receptor) therapy,
such as Iressa (gefitinib) or Erbitux (cetuximab, C225)

- Previous radiation to the chest or breast

- Subjects with breast reconstruction prior to RT

- Previous diagnosis of radiosensitivity disorder (i.e., ataxia telangiectasia)

- Previous diagnosis of collagen vascular disorder or vasculitis

- Presence of unhealed surgical wounds in chest or breast region and/or breast infection

- Current daily application of a prescribed topical product to the skin within the RT
area for an unrelated skin condition that cannot be discontinued during the
participation in this clinical trial

- Presence of any active dermatological issues in radiation treatment area (i.e., fungal
skin infection, dermatitis, psoriasis plaques, etc)