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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00176 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB-32439 | Other Identifier | Stanford IRB | |
| ENT0042 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase 3 trial studies how well modified Dakin's solution works in reducing radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.
Radiation therapy in this study is regulatory medical care based on the patient's needs and the radiation oncologist's judgment. It is not possible nor necessary to explicitly define the dose or duration of treatment.
PRIMARY OBJECTIVES:
I. To determine the proportion of patients who develop grade 3 radiation dermatitis (as defined by the Stanford Radiation Dermatitis Scoring System) as an adverse effect of radiation therapy or chemoradiation therapy for a head and neck cancer when initiating the use of prophylactic hypochlorite (HOCl) (modified Dakin's solution) at the start of therapy (experimental arm) compared to placebo (control arm).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (EXPERIMENTAL): Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
ARM II (CONTROL): Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
At the time that Stanford Radiation Dermatitis Scoring System (SRDSS) Grade E radiation dermatitis develops, the participant will transition to standard management for radiation dermatitis. SRDSS, by grade, is as follows.
SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion."
After completion of study, patients are followed up at 6 to 10 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (modified Dakin's solution) | Experimental | Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. |
|
| Arm II (placebo) | Placebo Comparator | Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dakin's solution | Drug | Apply modified Dakin's solution (0.005 to 0.01%) topically |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Dermatitis | Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The outcome is reported by treatment group as the number and proportion of participants that experience SRDSS Grade E or greater radiation dermatitis through 10 weeks after completion of radiation treatment, a number without dispersion. SRDSS, by grade:
SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion" | From first radiation treatment up to 10 weeks after completion of radiation treatment. Because much of the study data was not provided by the prior investigator to the current Responsible Party, it is not possible to be more precise than stated. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Grade E Radiation Dermatitis | Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The time that SRDSS Grade E radiation dermatitis developed was noted. The outcome is reported by treatment group as the mean time to development of SRDSS Grade E radiation dermatitis, with standard deviation. SRDSS, by grade:
SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion." Additional information describing this outcome is not available. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Beadle | Stanford University Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center South Bay | San Jose | California | 95124 | United States | ||
| Stanford University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Modified Dakin's Solution) | Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. |
| FG001 | Arm II (Placebo) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2019 |
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| Placebo | Other | Applied topically |
|
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| up to 12 weeks (estimated) |
| Pain Associated With Radiation Dermatitis | Quality of life was assessed as pain associated with radiation dermatitis. Assessments were baseline and through treatment follow-up 3 to 12 weeks after completion of radiation treatment. The assessment was to be conducted with a Modified Brief Pain Inventory (MBPI), a 13-question survey with responses ranging from 0 to 10, and an overall score of 0 to 130. A higher score indicates more pain and less quality of life. The outcome was to be reported by treatment group as the mean score with standard deviation. Additional information describing this outcome is not available. | 3 to 12 weeks after completion of radiation treatment |
| Stanford |
| California |
| 94305 |
| United States |
Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Modified Dakin's Solution) | Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. |
| BG001 | Arm II (Placebo) | Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. |
| BG002 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Baseline dermatitis | Count of Participants | Participants |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiation Dermatitis | Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The outcome is reported by treatment group as the number and proportion of participants that experience SRDSS Grade E or greater radiation dermatitis through 10 weeks after completion of radiation treatment, a number without dispersion. SRDSS, by grade:
SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion" | Not all participants completed radiation treatment, and are not included in the outcome. | Posted | Count of Participants | Participants | From first radiation treatment up to 10 weeks after completion of radiation treatment. Because much of the study data was not provided by the prior investigator to the current Responsible Party, it is not possible to be more precise than stated. |
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| Secondary | Time to Grade E Radiation Dermatitis | Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The time that SRDSS Grade E radiation dermatitis developed was noted. The outcome is reported by treatment group as the mean time to development of SRDSS Grade E radiation dermatitis, with standard deviation. SRDSS, by grade:
SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion." Additional information describing this outcome is not available. | Data for time to Grade E radiation dermatitis was not provided by the prior investigator to the current Responsible Party. On this basis, data is not available, and will never be available. | Posted | up to 12 weeks (estimated) |
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| Secondary | Pain Associated With Radiation Dermatitis | Quality of life was assessed as pain associated with radiation dermatitis. Assessments were baseline and through treatment follow-up 3 to 12 weeks after completion of radiation treatment. The assessment was to be conducted with a Modified Brief Pain Inventory (MBPI), a 13-question survey with responses ranging from 0 to 10, and an overall score of 0 to 130. A higher score indicates more pain and less quality of life. The outcome was to be reported by treatment group as the mean score with standard deviation. Additional information describing this outcome is not available. | Data for pain associated with radiation dermatitis was not provided by the prior investigator to the current Responsible Party. On this basis, data is not available, and will never be available. | Posted | 3 to 12 weeks after completion of radiation treatment |
|
Duration of the study - from consent to the end of follow-up (follow-up visit 3 to 12 weeks after completion of treatment). Because much of the study data was not provided by the prior investigator to the current Responsible Party, it is not possible to be more precise than stated.
Reported adverse events represent the entire set of adverse events as available to the current investigator and Responsible Party. There are no additional events available to report, and there never will be.
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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 (Modified Dakin's Solution) | Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. | 1 | 64 | 34 | 64 | 53 | 64 |
| EG001 | Arm II (Placebo) | Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. | 0 | 68 | 36 | 68 | 55 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radiation dermatitis | Injury, poisoning and procedural complications | CTCAE v4.03 | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Acneiform Rash | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Mucositis | Gastrointestinal disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Chest pain | Cardiac disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Other, Foot ulcer | Injury, poisoning and procedural complications | CTCAE v4.03 | Non-systematic Assessment |
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| Other, shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Aspiration, pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Fever | General disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE v4.03 | Non-systematic Assessment |
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| Colonic perforation | Gastrointestinal disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Meningitis | Infections and infestations | CTCAE v4.03 | Non-systematic Assessment |
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| Other, Feeding tube dysfunction | Surgical and medical procedures | CTCAE v4.03 | Non-systematic Assessment |
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| Pain, shoulder pain | General disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radiation dermatitis | Injury, poisoning and procedural complications | CTCAE v4.03 | Systematic Assessment | Development of grade 1 or higher non-serious radiation dermatitis (per CTCAE) |
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| Abdominal pain | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
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| Mucositis | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE v4.03 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Beadle | Stanford University | 650-723-6194 | bbeadle@stanford.edu |
| Jun 14, 2019 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017670 | Sodium Compounds |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units |
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| Participants |
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