Head and Neck CarcinomaPhase 3NCT02369835
Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
A Phase 3 study testing Dakin's solution in people with Head and Neck Carcinoma and Radiation-Induced Dermatitis, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma, Radiation-Induced Dermatitis
- What is being tested?
- Dakin's solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to 18 Jul 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford Cancer Center South Bay
San Jose, California, 95124
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Dakin's solution, Placebo
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dakin's solutionDrug
Also called Sodium hypochlorite in aqueous solution, Dakin's fluid, Liquid bleach
Apply modified Dakin's solution (0.005 to 0.01%) topically
PlaceboOther
Also called PLCB
Applied topically
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dakin's solution |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 to 12 weeks after completion of radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startMay 2015
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Beth Beadle, Stanford University
- Investigators
- Beth Beadle, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369835
- Sponsor's protocol ID
- IRB-32439
- Other IDs
- NCI-2015-00176, IRB-32439, ENT0042
- Status last verified
- Jan 2024
- First submitted
- 17 Feb 2015
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02369835
- Acronym / sponsor ID
- IRB-32439
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2015
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Posted 17 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (modified Dakin's solution) | Experimental | Drug: Dakin's solutionParticipants 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 | Other: PlaceboParticipants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dakin's solutionAlso: Sodium hypochlorite in aqueous solution, Dakin's fluid, Liquid bleachApply modified Dakin's solution (0.005 to 0.01%) topically | Drug | Arm I (modified Dakin's solution) |
| PlaceboAlso: PLCBApplied topically | Other | Arm II (placebo) |
Primary outcome
Radiation Dermatitis
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.
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"
2 secondary outcomes
Time to Grade E Radiation Dermatitis
Time frame: up to 12 weeks (estimated)
Pain Associated With Radiation Dermatitis
Time frame: 3 to 12 weeks after completion of radiation treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Beadle principal investigator
Stanford University Hospitals and Clinics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dakin's solution in people with Head and Neck Carcinoma and Radiation-Induced Dermatitis, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Dermatitis (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.