Head and Neck Carcinoma, Radiation-Induced Dermatitis
Conditions
Brief summary
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.
Detailed description
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. * A. No skin change * B. Faint, barely detectable erythema * C. Follicular rash, hyperpigmentation, evolving erythema * D. Dry desquamation, brisk erythema * E. Moist desquamation * F. Bleeding, ulceration, and/or infection 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.
Interventions
DRUGDakin's solution
Apply modified Dakin's solution (0.005 to 0.01%) topically
OTHERPlacebo
Applied topically
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Head and neck cancer who plan to undergo radiation therapy to the head and neck region * At least 18 years of age * Able to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Prior radiation therapy to the head and neck region or prior chemotherapy for head and neck cancer (induction chemotherapy NOT excluded) * The physician-approved radiation treatment plan indicates a maximum prescription dose of less than 45 Gy * Scleroderma or discoid lupus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dermatitis | 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. | 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: * A. No skin change * B. Faint, barely detectable erythema * C. Follicular rash, hyperpigmentation, evolving erythema * D. Dry desquamation, brisk erythema * E. Moist desquamation * F. Bleeding, ulceration, and/or infection 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Grade E Radiation Dermatitis | up to 12 weeks (estimated) | 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: * A. No skin change * B. Faint, barely detectable erythema * C. Follicular rash, hyperpigmentation, evolving erythema * D. Dry desquamation, brisk erythema * E. Moist desquamation * F. Bleeding, ulceration, and/or infection 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. |
| Pain Associated With Radiation Dermatitis | 3 to 12 weeks after completion of radiation treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 64 |
| 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. | 68 |
| Total | 132 |
Baseline characteristics
| Characteristic | Arm I (Modified Dakin's Solution) | Arm II (Placebo) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 26 Participants | 61 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 42 Participants | 71 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 11.6 | 62 years STANDARD_DEVIATION 12.7 | 63.5 years STANDARD_DEVIATION 12.3 |
| Baseline dermatitis | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 9 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) White | 45 Participants | 49 Participants | 94 Participants |
| Region of Enrollment United States | 64 participants | 68 participants | 132 participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 54 Participants | 54 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 64 | 0 / 68 |
| other Total, other adverse events | 53 / 64 | 55 / 68 |
| serious Total, serious adverse events | 34 / 64 | 36 / 68 |
Outcome results
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: * A. No skin change * B. Faint, barely detectable erythema * C. Follicular rash, hyperpigmentation, evolving erythema * D. Dry desquamation, brisk erythema * E. Moist desquamation * F. Bleeding, ulceration, and/or infection 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
Time frame: 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.
Population: Not all participants completed radiation treatment, and are not included in the outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Modified Dakin's Solution) | Radiation Dermatitis | 34 Participants |
| Arm II (Placebo) | Radiation Dermatitis | 36 Participants |
p-value: 0.8872Chi-squared
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.
Time frame: 3 to 12 weeks after completion of radiation treatment
Population: 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.
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: * A. No skin change * B. Faint, barely detectable erythema * C. Follicular rash, hyperpigmentation, evolving erythema * D. Dry desquamation, brisk erythema * E. Moist desquamation * F. Bleeding, ulceration, and/or infection 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.
Time frame: up to 12 weeks (estimated)
Population: 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.