Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer
Condition: Breast Carcinoma; Pain; Radiation-Induced Dermatitis; Stage 0 Breast Cancer
MeSH terms: Breast Neoplasms; Breast Carcinoma In Situ; Dermatitis; Radiodermatitis
Intervention: Curcumin-based Gel; Dermatologic Complications Management; Laboratory Biomarker Analysis; Placebo; Questionnaire Administration
Intervention description: Applied topically; Apply HPR Plus topically; Correlative studies; Apply placebo gel topically; Ancillary studies
Intervention MeSH terms: Curcumin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 191.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No

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.
    

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)