Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer (Curcumin-II)

• ClinicalTrials.gov Identifier: NCT02556632
• Recruitment Status: Completed
• First Posted: September 22, 2015
• Results First Posted: November 6, 2017
• Last Update Posted: November 6, 2017
• Sponsor: Gary Morrow
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Gary Morrow, University of Rochester NCORP Research Base

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Conditions: Breast Carcinoma; Pain; Radiation-Induced Dermatitis; Stage 0 Breast Cancer
• Interventions: Drug: Curcumin-based Gel; Procedure: Dermatologic Complications Management; Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Questionnaire Administration
• Enrollment: 191

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
Arm/Group Description	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	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	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
Period Title: Overall Study
Started	64	65	62
Completed	59	59	53
Not Completed	5	6	9
Reason Not Completed
Lost to Follow-up	1	0	0
Disliked Intervention	1	1	1
No Reason	1	0	1
Personal Issues	0	1	1
Changed Mind	0	1	0
Withdrew (Unrelated Medical)	1	0	0
Unrelated Adverse Event	1	0	3
Related Adverse Event	0	1	0
Possibly Related Adverse Event	0	0	1
Did Not Start RT	0	1	0
Ineligible	0	1	0
Disliked Study Procedures	0	0	1
Treatment or Change Delay	0	0	1

Baseline Characteristics

Arm/Group Title		Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)	Total
Arm/Group Description		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	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	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	Total of all reporting groups
Overall Number of Baseline Participants		64	65	62	191
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
		59.0 (11.2)	60.7 (10.5)	59.8 (9.3)	59.8 (10.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	Female	64 100.0%	65 100.0%	62 100.0%	191 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	Hispanic or Latino	2 3.1%	0 0.0%	1 1.6%	3 1.6%
	Not Hispanic or Latino	62 96.9%	63 96.9%	61 98.4%	186 97.4%
	Unknown or Not Reported	0 0.0%	2 3.1%	0 0.0%	2 1.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	1 1.5%	1 1.6%	2 1.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	8 12.5%	9 13.8%	4 6.5%	21 11.0%
	White	55 85.9%	55 84.6%	57 91.9%	167 87.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 1.6%	0 0.0%	0 0.0%	1 0.5%
Marital Status; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	Married	45 70.3%	37 56.9%	37 59.7%	119 62.3%
	Domestic Partner	0 0.0%	0 0.0%	1 1.6%	1 0.5%
	Divorced	5 7.8%	9 13.8%	16 25.8%	30 15.7%
	Separated	1 1.6%	0 0.0%	1 1.6%	2 1.0%
	Single	8 12.5%	8 12.3%	2 3.2%	18 9.4%
	Widowed	5 7.8%	10 15.4%	4 6.5%	19 9.9%
	Unknown or Not Reported	0 0.0%	1 1.5%	1 1.6%	2 1.0%
Stage of Disease [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	DCIS	5 7.8%	12 18.5%	11 17.7%	28 14.7%
	Stage I	34 53.1%	29 44.6%	22 35.5%	85 44.5%
	Stage II	16 25.0%	18 27.7%	20 32.3%	54 28.3%
	Stage III	7 10.9%	5 7.7%	8 12.9%	20 10.5%
	Stage IV	2 3.1%	0 0.0%	0 0.0%	2 1.0%
	Unknown or Not Reported	0 0.0%	1 1.5%	1 1.6%	2 1.0%
		[1] Measure Description: 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.
Location of Breast Cancer; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	Left	29 45.3%	27 41.5%	30 48.4%	86 45.0%
	Right	35 54.7%	37 56.9%	31 50.0%	103 53.9%
	Unknown or Not Reported	0 0.0%	1 1.5%	1 1.6%	2 1.0%
Prior Chemotherapy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	No	30 46.9%	35 53.8%	34 54.8%	99 51.8%
	Yes	34 53.1%	29 44.6%	27 43.5%	90 47.1%
	Unknown or Not Reported	0 0.0%	1 1.5%	1 1.6%	2 1.0%
Currently on Hormone Therapy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	No	52 81.3%	48 73.8%	48 77.4%	148 77.5%
	Yes	12 18.8%	16 24.6%	13 21.0%	41 21.5%
	Unknown or Not Reported	0 0.0%	1 1.5%	1 1.6%	2 1.0%
Currently on Herceptin Treatment; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	No	56 87.5%	56 86.2%	58 93.5%	170 89.0%
	Yes	8 12.5%	8 12.3%	3 4.8%	19 9.9%
	Unknown or Not Reported	0 0.0%	1 1.5%	1 1.6%	2 1.0%
Type of Radiation; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	IMRT	1 1.6%	2 3.1%	2 3.2%	5 2.6%
	3D Conformal Whole Breast	63 98.4%	62 95.4%	59 95.2%	184 96.3%
	Unknown or Not Reported	0 0.0%	1 1.5%	1 1.6%	2 1.0%
Radiation Boost Planned; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants	65 participants	62 participants	191 participants
	No	4 6.3%	3 4.6%	2 3.2%	9 4.7%
	Yes	60 93.8%	61 93.8%	59 95.2%	180 94.2%
	Unknown or Not Reported	0 0.0%	1 1.5%	1 1.6%	2 1.0%
Total Radiation Dose Prescribed [1] [2]; Mean (Standard Deviation); Unit of measure: Gray units
	Number Analyzed	64 participants	64 participants	61 participants	189 participants
		58.4 (5.6)	59.5 (4.5)	59.1 (5.2)	59.0 (5.1)
		[1] Measure Description: 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.; [2] Measure Analysis Population Description: 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.
Breast Field Separation [1] [2]; Mean (Standard Deviation); Unit of measure: Centimeters
	Number Analyzed	64 participants	64 participants	61 participants	189 participants
		22.6 (4.0)	23.8 (4.2)	22.8 (5.5)	23.1 (4.6)
		[1] Measure Description: 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.; [2] Measure Analysis Population Description: 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.

Outcome Measures

1. Primary Outcome

Title	Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)
Description	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.
Time Frame	Baseline up to 1 week post radiation therapy

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
Arm/Group Description:	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	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	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
Overall Number of Participants Analyzed	59	59	53
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.68 (0.74)	2.64 (0.74)	2.63 (0.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin-based Gel), Arm II (HPR Plus), Arm III (Placebo Gel)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9306
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

2. Primary Outcome

Title	Incidence of Moist Desquamation (Present vs. Absent)
Description	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.
Time Frame	Baseline up to completion of radiation therapy

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
Arm/Group Description:	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	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	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
Overall Number of Participants Analyzed	59	59	53
Measure Type: Count of Participants; Unit of Measure: Participants
No Moist Desquamation	44 74.6%	47 79.7%	41 77.4%
Moist Desquamation	15 25.4%	12 20.3%	12 22.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin-based Gel), Arm II (HPR Plus), Arm III (Placebo Gel)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8048
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

3. Primary Outcome

Title	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)
Description	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.
Time Frame	Baseline to up to 1 week after completion of radiation therapy

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
Arm/Group Description:	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	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	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
Overall Number of Participants Analyzed	60	58	52
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.25 (0.99)	2.16 (0.92)	2.15 (0.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin-based Gel), Arm II (HPR Plus), Arm III (Placebo Gel)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8591
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
Arm/Group Description	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	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	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
All-Cause Mortality
	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/64 (0.00%)	1/65 (1.54%)	0/62 (0.00%)
Serious Adverse Events
	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/64 (4.69%)	2/65 (3.08%)	6/62 (9.68%)
Cardiac disorders
Heart Failure * 1	0/64 (0.00%)	1/65 (1.54%)	1/62 (1.61%)
Injury, poisoning and procedural complications
Radiation Dermatitis * 1	3/64 (4.69%)	1/65 (1.54%)	4/62 (6.45%)
Nervous system disorders
Headache * 1	0/64 (0.00%)	0/65 (0.00%)	1/62 (1.61%)
Respiratory, thoracic and mediastinal disorders
Pleuritic pain * 1	0/64 (0.00%)	1/65 (1.54%)	0/62 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis * 1	1/64 (1.56%)	0/65 (0.00%)	0/62 (0.00%)
1 Term from vocabulary, CTCAE (4.0); * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	8/64 (12.50%)	3/65 (4.62%)	5/62 (8.06%)
Gastrointestinal disorders
Gastrointestinal disorders - Other: yellow colored bowel movements * 1	0/64 (0.00%)	0/65 (0.00%)	1/62 (1.61%)
General disorders
Localized edema - Breast swelling * 1	1/64 (1.56%)	0/65 (0.00%)	0/62 (0.00%)
Pain * 1	1/64 (1.56%)	1/65 (1.54%)	0/62 (0.00%)
Fatigue * 1	0/64 (0.00%)	1/65 (1.54%)	0/62 (0.00%)
Pain of skin * 1	0/64 (0.00%)	0/65 (0.00%)	1/62 (1.61%)
Immune system disorders
Allergic reaction * 1	1/64 (1.56%)	0/65 (0.00%)	1/62 (1.61%)
Injury, poisoning and procedural complications
Dermatitis radiation * 1	3/64 (4.69%)	1/65 (1.54%)	0/62 (0.00%)
Reproductive system and breast disorders
Breast pain * 1	1/64 (1.56%)	1/65 (1.54%)	0/62 (0.00%)
Nipple pain * 1	1/64 (1.56%)	0/65 (0.00%)	0/62 (0.00%)
Skin and subcutaneous tissue disorders
Erythematous papular rash * 1	1/64 (1.56%)	0/65 (0.00%)	0/62 (0.00%)
Pain of skin * 1	2/64 (3.13%)	0/65 (0.00%)	1/62 (1.61%)
Pruritis * 1	3/64 (4.69%)	1/65 (1.54%)	1/62 (1.61%)
Dermatitis radiation * 1	0/64 (0.00%)	0/65 (0.00%)	2/62 (3.23%)
Skin and subcutaneous tissue disorders (Other, Specify) * 1	1/64 (1.56%)	0/65 (0.00%)	0/62 (0.00%)
Rash maculo-papular * 1	0/64 (0.00%)	0/65 (0.00%)	1/62 (1.61%)
Papulpustular rash * 1	0/64 (0.00%)	0/65 (0.00%)	1/62 (1.61%)
Vascular disorders
Lymphedema * 1	1/64 (1.56%)	0/65 (0.00%)	0/62 (0.00%)
Vascular disorders - Other: hellow colored hidrosis * 1	0/64 (0.00%)	0/65 (0.00%)	1/62 (1.61%)
1 Term from vocabulary, CTCAE (4.0); * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Julie Ryan Wolf, PhD, MPH; Associate Professor of Dermatology and Radiation Oncology
• Organization: University of Rochester
• Phone: 585-276-3862
• EMail: julie_ryan@urmc.rochester.edu

• Responsible Party: Gary Morrow, 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 Submitted: July 23, 2015
• First Posted: September 22, 2015
• Results First Submitted: August 28, 2017
• Results First Posted: November 6, 2017
• Last Update Posted: November 6, 2017