prophylactic topical agents in reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer

Conditions: Breast Carcinoma; Pain; Radiation-Induced Dermatitis; Stage 0 Breast Cancer

Summary: this randomized pilot phase ii trial studies and compares prophylactic topical agents in reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer or breast cancer in situ. the prophylactic topical agents, such as curcumin-based gel or hpr plus, may reduce the severity of the radiation-induced dermatitis by minimizing water loss and inflammation during radiation therapy.

primary objective: i. to investigate the effectiveness of curcumin gel (curcumin-based gel) or hpr plus™ in reducing radiation dermatitis in breast cancer patients.

Eligibility criteria:
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)