Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer (Curcumin-II)
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ClinicalTrials.gov Identifier: NCT02556632 |
Recruitment Status :
Completed
First Posted : September 22, 2015
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
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Condition or disease | Intervention/treatment | Phase |
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Breast Carcinoma Pain Radiation-Induced Dermatitis Stage 0 Breast Cancer | Drug: Curcumin-based Gel Procedure: Dermatologic Complications Management Other: Laboratory Biomarker Analysis Other: Placebo Other: Questionnaire Administration | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 191 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Effectiveness of Prophylactic Topical Agents for Radiation Dermatitis |
Actual Study Start Date : | October 13, 2015 |
Actual Primary Completion Date : | September 30, 2016 |
Actual Study Completion Date : | September 30, 2016 |

Arm | Intervention/treatment |
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Experimental: Arm I (curcumin-based gel)
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.
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Drug: Curcumin-based Gel
Applied topically
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Other: Questionnaire Administration Ancillary studies |
Experimental: Arm II (HPR Plus)
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.
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Procedure: Dermatologic Complications Management
Apply HPR Plus topically Other: Laboratory Biomarker Analysis Correlative studies Other: Questionnaire Administration Ancillary studies |
Placebo Comparator: Arm III (placebo gel)
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.
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Other: Laboratory Biomarker Analysis
Correlative studies Other: Placebo Apply placebo gel topically
Other Names:
Other: Questionnaire Administration Ancillary studies |
- Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) [ Time Frame: Baseline up to 1 week post radiation therapy ]
The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT.
The RDS score ranges from 0-4 with higher scores indicating worse outcome.
- Incidence of Moist Desquamation (Present vs. Absent) [ Time Frame: Baseline up to completion of radiation therapy ]The degree to which each topical intervention decreases the incidence of moist desquamation will be examined using Fisher's exact test. Each agent's potential as a preventative intervention will be determined through comparison of the proportion of subjects with no to minimal radiation dermatitis within each arm using Fisher's exact test.
- Change in the Severity of Skin Reactions Using the Radiation Dermatitis Scale (RDS). Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) [ Time Frame: Baseline to up to 1 week after completion of radiation therapy ]
The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions after completion of RT.
The RDS score ranges from 0-4 with higher scores indicating worse outcome.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556632
United States, Delaware | |
Delaware/Christiana Care NCORP | |
Newark, Delaware, United States, 19713 | |
United States, Illinois | |
Heartland NCORP | |
Decatur, Illinois, United States, 62526 | |
United States, Minnesota | |
Metro-Minnesota NCORP | |
Minneapolis, Minnesota, United States, 55426 | |
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
Columbus NCORP | |
Columbus, Ohio, United States, 43215 | |
Dayton Oncology Research Program | |
Dayton, Ohio, United States, 45420 |
Principal Investigator: | Gary Morrow | University of Rochester NCORP Research Base |
Responsible Party: | Gary Morrow, Director, University of Rochester NCORP Research Base |
ClinicalTrials.gov Identifier: | NCT02556632 |
Other Study ID Numbers: |
URCC14079 NCI-2015-00869 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) URCC14079 ( Other Identifier: University of Rochester NCORP Research Base ) URCC-14079 ( Other Identifier: DCP ) R21CA178648 ( U.S. NIH Grant/Contract ) UG1CA189961 ( U.S. NIH Grant/Contract ) |
First Posted: | September 22, 2015 Key Record Dates |
Results First Posted: | November 6, 2017 |
Last Update Posted: | November 6, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Breast Neoplasms Breast Carcinoma In Situ Dermatitis Radiodermatitis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Radiation Injuries |
Wounds and Injuries Curcumin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |