Trial · NCT02556632
Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer
NCT02556632, Phase 2, Completed, Gary Morrow; results first posted 2017-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer. Trials, record NCT02556632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02556632
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer
- NCT number
- NCT02556632
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 191 participants, actual
- Lead sponsor
- Gary Morrow
- Conditions
- Breast Carcinoma, Pain, Radiation-Induced Dermatitis, Stage 0 Breast Cancer
- Interventions
- Curcumin-based Gel, Dermatologic Complications Management, Laboratory Biomarker Analysis, Placebo, Questionnaire Administration
- First posted
- 2015-09-22
- Last updated
- 2017-11-06
- Results first posted
- 2017-11-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) | 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. |
| Primary | Incidence of Moist Desquamation (Present vs. Absent) | 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. |
| 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) | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) | Baseline up to 1 week post radiation therapy | 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 | units on a scale | MEAN |
| PRIMARY | Incidence of Moist Desquamation (Present vs. Absent) | Baseline up to completion of radiation therapy | 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 | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Baseline to up to 1 week after completion of radiation therapy | 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. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) | Arm I (Curcumin-based Gel) | 2.68 | Standard Deviation 0.74 | units on a scale | |
| Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) | Arm II (HPR Plus) | 2.64 | Standard Deviation 0.74 | units on a scale | |
| Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) | Arm III (Placebo Gel) | 2.63 | Standard Deviation 0.69 | units on a scale | |
| Incidence of Moist Desquamation (Present vs. Absent) | Arm I (Curcumin-based Gel) | No Moist Desquamation | 44 | Participants | |
| Incidence of Moist Desquamation (Present vs. Absent) | Arm II (HPR Plus) | No Moist Desquamation | 47 | Participants | |
| Incidence of Moist Desquamation (Present vs. Absent) | Arm III (Placebo Gel) | No Moist Desquamation | 41 | Participants | |
| Incidence of Moist Desquamation (Present vs. Absent) | Arm I (Curcumin-based Gel) | Moist Desquamation | 15 | Participants | |
| Incidence of Moist Desquamation (Present vs. Absent) | Arm II (HPR Plus) | Moist Desquamation | 12 | Participants | |
| Incidence of Moist Desquamation (Present vs. Absent) | Arm III (Placebo Gel) | Moist Desquamation | 12 | Participants | |
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) | Arm I (Curcumin-based Gel) | 2.25 | Standard Deviation 0.99 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Curcumin-based Gel) | 64 | |
| Overall Study | STARTED | Arm II (HPR Plus) | 65 | |
| Overall Study | STARTED | Arm III (Placebo Gel) | 62 | |
| Overall Study | COMPLETED | Arm I (Curcumin-based Gel) | 59 | |
| Overall Study | COMPLETED | Arm II (HPR Plus) | 59 | |
| Overall Study | COMPLETED | Arm III (Placebo Gel) | 53 | |
| Overall Study | NOT COMPLETED | Arm I (Curcumin-based Gel) | 5 | |
| Overall Study | NOT COMPLETED | Arm II (HPR Plus) | 6 | |
| Overall Study | NOT COMPLETED | Arm III (Placebo Gel) | 9 |
Source ClinicalTrials.gov
Adverse events69
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Erythematous papular rash | Skin and subcutaneous tissue disorders | Arm I (Curcumin-based Gel) | 1 | 64 | |
| other | Erythematous papular rash | Skin and subcutaneous tissue disorders | Arm II (HPR Plus) | 0 | 65 | |
| other | Erythematous papular rash | Skin and subcutaneous tissue disorders | Arm III (Placebo Gel) | 0 | 62 | |
| other | Allergic reaction | Immune system disorders | Arm I (Curcumin-based Gel) | 1 | 64 | |
| other | Allergic reaction | Immune system disorders | Arm II (HPR Plus) | 0 | 65 | |
| other | Allergic reaction | Immune system disorders | Arm III (Placebo Gel) | 1 | 62 | |
| other | Pain of skin | Skin and subcutaneous tissue disorders | Arm I (Curcumin-based Gel) | 2 | 64 | |
| other | Pain of skin | Skin and subcutaneous tissue disorders | Arm II (HPR Plus) | 0 | 65 | |
| other | Pain of skin | Skin and subcutaneous tissue disorders | Arm III (Placebo Gel) | 1 | 62 | |
| other | Pruritis | Skin and subcutaneous tissue disorders | Arm I (Curcumin-based Gel) | 3 | 64 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Curcumin-based Gel) | 0 | 64 |
| Total, all-cause mortality | Arm II (HPR Plus) | 1 | 65 |
| Total, all-cause mortality | Arm III (Placebo Gel) | 0 | 62 |
| Total, other adverse events | Arm I (Curcumin-based Gel) | 8 | 64 |
| Total, other adverse events | Arm II (HPR Plus) | 3 | 65 |
| Total, other adverse events | Arm III (Placebo Gel) | 5 | 62 |
| Total, serious adverse events | Arm I (Curcumin-based Gel) | 3 | 64 |
| Total, serious adverse events | Arm II (HPR Plus) | 2 | 65 |
| Total, serious adverse events | Arm III (Placebo Gel) | 6 | 62 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UG1CA189961 | URCC NCORP Research Base | MUSTIAN, KAREN M.; MORROW, GARY R | UNIVERSITY OF ROCHESTER | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| R21CA178648 | Effectiveness of Prophylactic Topical Treatments for Radiation Dermatitis | WOLF, JULIE RYAN | UNIVERSITY OF ROCHESTER | NATIONAL CANCER INSTITUTE | 2014 to 2015 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02556632
GET https://conductscience.org/api/trials/v1/NCT02556632/events?page=2