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Trial record 43 of 80 for:    "curcumin" and "cancer"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Curcumin-based Gel) Arm II (HPR Plus) Arm III (Placebo Gel)
Hide 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
Arm/Group Title Arm I (Curcumin-based Gel) Arm II (HPR Plus) Arm III (Placebo Gel) Total
Hide 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
Hide 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.
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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Show Statistical Analysis 1 Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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%
Show Statistical Analysis 1 Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Show Statistical Analysis 1 Hide 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]
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)
Hide 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%) 
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
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
Layout table for additonal information
Responsible Party: Gary Morrow, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT02556632     History of Changes
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