Overview

This trial has been completed.

Conditions breast carcinoma, pain, radiation-induced dermatitis, stage 0 breast cancer
Treatments curcumin-based gel, dermatologic complications management, laboratory biomarker analysis, placebo, questionnaire administration
Phase phase 2
Sponsor Gary Morrow
Collaborator National Cancer Institute (NCI)
Start date October 2015
End date September 2016
Trial size 191 participants
Trial identifier NCT02556632, NCI-2015-00869, R21CA178648, UG1CA189961, URCC-14079, URCC14079

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
curcumin-based gel Curcumin Gel
Applied topically
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
(Experimental)
Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
dermatologic complications management
Apply HPR Plus topically
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
(Placebo Comparator)
Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
laboratory biomarker analysis
Correlative studies
placebo placebo therapy
Apply placebo gel topically
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
Change in the severity of skin reactions
time frame: Baseline to up to 1 week after completion of radiation therapy
Incidence of moist desquamation (i.e., associated with RDS 3.5 and 4.0)
time frame: Up to 1 week after completion of radiation therapy
Mean radiation dermatitis severity (RDS) score
time frame: Up to 1 week after completion of radiation therapy

Secondary Outcomes

Measure
Changes in pain measured by Self-Report Pain Diary
time frame: Baseline to up to 2 weeks after completion of radiation therapy
Changes in pain severity measured by the Skin-Pain Inventory and Short Form McGill Pain Questionnaire
time frame: Baseline to up to 2 weeks after completion of radiation therapy

Eligibility Criteria

Female participants at least 21 years old.

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)

Additional Information

Official title Effectiveness of Prophylactic Topical Agents for Radiation Dermatitis
Principal investigator Gary Morrow
Description PRIMARY OBJECTIVES: I. To investigate the effectiveness of Curcumin gel (curcumin-based gel) or HPR Plus™ in reducing radiation dermatitis in breast cancer patients. SECONDARY OBJECTIVES: I. To investigate the effectiveness of Curcumin gel or HPR Plus™ in reducing pain from radiation therapy (RT)-induced skin reactions. TERTIARY OBJECTIVES: I. To evaluate the feasibility of administering prophylactic topical treatments for radiation dermatitis to breast cancer patients receiving RT. II. Identify a blood biomarker that correlates with the severity of radiation dermatitis at the end of RT and a biomarker for response to topical treatment. III. Evaluate the feasibility and accuracy of using "central blinded reviewers" for rating radiation dermatitis severity on digital photographs. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients apply curcumin-based gel three times daily (TID) approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. ARM II: Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. ARM III: Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. After completion of radiation therapy, patients are followed up at 2 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Rochester.