Trial Outcomes & Findings for Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy (NCT NCT02369835)

Last Updated: 2024-01-30

Results Overview

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"

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

132 participants

Primary outcome timeframe

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.

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	64	68
Overall Study COMPLETED	53	55
Overall Study NOT COMPLETED	11	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Modified Dakin's Solution) n=64 Participants 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) n=68 Participants Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	42 Participants n=7 Participants	71 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants	26 Participants n=7 Participants	61 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 11.6 • n=5 Participants	62 years STANDARD_DEVIATION 12.7 • n=7 Participants	63.5 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	49 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants	68 participants n=7 Participants	132 participants n=5 Participants
Baseline dermatitis	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm I (Modified Dakin's Solution) n=53 Participants 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) n=55 Participants Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
Radiation Dermatitis	34 Participants	36 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Modified Dakin's Solution)

Serious events: 34 serious events

Other events: 53 other events

Deaths: 1 deaths

Arm II (Placebo)

Serious events: 36 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm I (Modified Dakin's Solution) n=64 participants at risk 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) n=68 participants at risk Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
Injury, poisoning and procedural complications Radiation dermatitis	82.8% 53/64 • Number of events 53 • 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.	80.9% 55/68 • Number of events 55 • 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
Gastrointestinal disorders Bloating	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
Gastrointestinal disorders Mucositis	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
Gastrointestinal disorders Nausea	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
General disorders Fever	1.6% 1/64 • Number of events 1 • 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.	0.00% 0/68 • 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.

Additional Information

Beth Beadle

Stanford University

Phone: 650-723-6194

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (Modified Dakin's Solution) n=64 participants at risk 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) n=68 participants at risk Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
Injury, poisoning and procedural complications Radiation dermatitis	53.1% 34/64 • Number of events 34 • 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.	52.9% 36/68 • Number of events 36 • 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.
Cardiac disorders Cardiac arrest	1.6% 1/64 • Number of events 2 • 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.	0.00% 0/68 • 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.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.6% 1/64 • Number of events 2 • 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.	0.00% 0/68 • 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.
Skin and subcutaneous tissue disorders Acneiform Rash	1.6% 1/64 • Number of events 1 • 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.	0.00% 0/68 • 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.
Gastrointestinal disorders Mucositis	1.6% 1/64 • Number of events 1 • 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.	0.00% 0/68 • 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.
Cardiac disorders Chest pain	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
Injury, poisoning and procedural complications Other, Foot ulcer	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Other, shortness of breath	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Aspiration, pneumonia	3.1% 2/64 • Number of events 2 • 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.	0.00% 0/68 • 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.
General disorders Fever	1.6% 1/64 • Number of events 1 • 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.	0.00% 0/68 • 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.
Infections and infestations Sepsis	1.6% 1/64 • Number of events 1 • 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.	0.00% 0/68 • 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.
Gastrointestinal disorders Colonic perforation	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
Infections and infestations Meningitis	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
Surgical and medical procedures Other, Feeding tube dysfunction	0.00% 0/64 • 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.	1.5% 1/68 • Number of events 1 • 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.
General disorders Pain, shoulder pain	1.6% 1/64 • Number of events 2 • 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.	0.00% 0/68 • 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.