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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (curcumin-based gel) | 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. |
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| Arm II (HPR Plus) | 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. |
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| Arm III (placebo gel) | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin-based Gel | Drug | Applied topically |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) | 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. | Baseline up to 1 week post radiation therapy |
| Incidence of Moist Desquamation (Present vs. Absent) | 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. | Baseline up to completion of radiation therapy |
| 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) | 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. | Baseline to up to 1 week after completion of radiation therapy |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Morrow | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delaware/Christiana Care NCORP | Newark | Delaware | 19713 | United States | ||
| Heartland NCORP |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Curcumin-based Gel: Applied topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dermatologic Complications Management | Procedure | Apply HPR Plus topically |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Placebo | Other | Apply placebo gel topically |
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| Questionnaire Administration | Other | Ancillary studies |
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| Decatur |
| Illinois |
| 62526 |
| United States |
| Metro-Minnesota NCORP | Minneapolis | Minnesota | 55426 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Columbus NCORP | Columbus | Ohio | 43215 | United States |
| Dayton Oncology Research Program | Dayton | Ohio | 45420 | United States |
| FG001 |
| 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. Dermatologic Complications Management: Apply HPR Plus topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies |
| FG002 | 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. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Curcumin-based Gel: Applied topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies |
| BG001 | 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. Dermatologic Complications Management: Apply HPR Plus topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies |
| BG002 | 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. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Stage of Disease | Ductal carcinoma in situ (DCIS) is considered the earliest form of cancer and consists of abnormal cells in the milk duct. Stage I.This stage is a small cancer that has not grown deeply into nearby tissues and has not spread to lymph nodes. Stage II and III.These stages indicate larger cancers that have grown more deeply into nearby tissue and may have also spread to lymph nodes. Stage IV.This stage means that the cancer has spread to other organs or parts of the body. Unknown or Not Reported Stage. There is not enough information to determine stage. | Count of Participants | Participants |
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| Location of Breast Cancer | Count of Participants | Participants |
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| Prior Chemotherapy | Count of Participants | Participants |
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| Currently on Hormone Therapy | Count of Participants | Participants |
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| Currently on Herceptin Treatment | Count of Participants | Participants |
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| Type of Radiation | Count of Participants | Participants |
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| Radiation Boost Planned | Count of Participants | Participants |
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| Total Radiation Dose Prescribed | The international system (SI) unit of radiation dose expressed in terms of absorbed energy per unit mass of tissue. The gray is the unit of absorbed dose and has replaced the rad. 1 gray = 1 Joule/kilogram and also equals 100 rad. | The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out. | Mean | Standard Deviation | Gray units |
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| Breast Field Separation | Breast field separation (BFS) evaluates the association of breast size with radiation-induced skin toxicity. BFS can be obtained from the radiation treatment plan for both 3D conformal breast radiation and IMRT. BFS is defined as the distance between the medial and lateral tangential fields. The tangential fields are created during simulation to achieve uniform dose distribution to the breast volume. The tangential fields align with the medial and lateral contours of the breast. BFS is similar to the width measurement of the breast and is calculated as part of the radiation treatment plan. | The demographic data was captured in the Onstudy form but two of the participants did not get to the point to fill that form out. | Mean | Standard Deviation | centimeters |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) | 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. | Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study | Posted | Mean | Standard Deviation | units on a scale | Baseline up to 1 week post radiation therapy |
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| Primary | Incidence of Moist Desquamation (Present vs. Absent) | 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. | Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study | Posted | Count of Participants | Participants | Baseline up to completion of radiation therapy |
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| Primary | 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) | 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. | Note: Of the 64 who were randomized to Arm 1, 60 completed 1-week post; of the 65 who were randomized to Arm II, 58 completed 1-week post; of the 62 who were randomized to Arm III, 52 completed 1-week post. | Posted | Mean | Standard Deviation | units on a scale | Baseline to up to 1 week after completion of radiation therapy |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Curcumin-based Gel: Applied topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies | 0 | 64 | 3 | 64 | 8 | 64 |
| EG001 | 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. Dermatologic Complications Management: Apply HPR Plus topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies | 1 | 65 | 2 | 65 | 3 | 65 |
| EG002 | 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. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies | 0 | 62 | 6 | 62 | 5 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Radiation Dermatitis | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythematous papular rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Allergic reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dermatitis radiation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Localized edema - Breast swelling | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Nipple pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Skin and subcutaneous tissue disorders (Other, Specify) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Lymphedema | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pain of skin | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Papulpustular rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Gastrointestinal disorders - Other: yellow colored bowel movements | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Vascular disorders - Other: hellow colored hidrosis | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Ryan Wolf, PhD, MPH; Associate Professor of Dermatology and Radiation Oncology | University of Rochester | 585-276-3862 | julie_ryan@urmc.rochester.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010146 | Pain |
| D011855 | Radiodermatitis |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003872 | Dermatitis |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| OG002 | 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. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies |
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| OG002 | 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. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies |
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