Radiation DermatitisNCT05553392
StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis
A study testing StrataXRT and Aquaphor in people with Radiation Dermatitis, run by Stratpharma AG at 1 site in United States.
Trial summary
The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- StrataXRT and Aquaphor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy of at least 6 months
- Biopsy-confirmed malignancy without gross nodal involvement of the right or left inguinal regions
- Patients will receive elective radiation therapy to bilateral inguinal nodal regions prescribed to 45-50 Gy in 1.8-2 Gy fractions using photon or proton therapy
- No known allergy to studied products
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- Able to give written informed consent, or have written consent given on their behalf
- Patients who are able and willing to attend the post-radiation weekly skin assessment appointments
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if preferred by patient. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Who cannot join
- Patients with gross cancer involvement of either or both inguinal regions.
- Patients who have received prior pelvic and/or inguinal radiation therapy.
- Patients who cannot apply the studied products to the inguinal region or have it administered to them as required by this study.
- Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
- Patients with existing rashes or wounds in either inguinal region at baseline.
- Planned inguinal dissection within 90 days after completion of radiation therapy on this study.
- Female patients who are pregnant or breast feeding.
- Patients who are unable to give written informed consent, or are unable to have written consent given on their behalf.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis in Cancer Patients Receiving Elective Inguinal Radiation Therapy
The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.
- Conditions
- Radiation Dermatitis
- Being tested
- StrataXRT, Aquaphor
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrataXRTDevice
StrataXRT is a full contact flexible wound dressing for the prevention and treatment of radiation dermatitis. StrataXRT is a semi-occlusive, self-drying and transparent gel.
When used as directed StrataXRT dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion. StrataXRT may be directly applied to radiation dermatitis, compromised skin surfaces, superficial wounds and first and second degree burns.
AquaphorDrug
Aquaphor is a brand of over-the-counter (OTC) skin care ointments manufactured by Beiersdorf Inc.
Aquaphor contains 41 percent petrolatum (or petroleum jelly), the active ingredient, temporarily protects minor cuts, scrapes, and burns; protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather.
| Study group | Role | What they receive |
|---|---|---|
| StrataXRT | Experimental | Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to both the right and left inguinal regions. The studied products will be used daily during the entire course of radiotherapy including on weekends and holidays until at least 4 weeks upon completion of radiation therapy or otherwise until resolution of RD on both sides. Receives: Device: StrataXRT |
| Aquaphor | Active comparator | Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to the entire treatment field. The studied products will be used during the entire course of radiotherapy and for a further 4 weeks upon completion of radiation therapy. Receives: Drug: Aquaphor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute >grade 2 radiation dermatitis
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD (19). This instrument is routinely used and well validated in radiation oncology for assessing radiation dermatitis (20). This weekly assessment will be undertaken by the assessor who is blinded to the allocation. The assessor will be instructed prior to the first fraction of radiation therapy to score the worst toxicity present, at the time of assessment within the treatment field which consists of the bilateral inguinal regions.
The amount of > grade 2 RD cases will be compared in both study groups.
Measured: Until 8 weeks post radiation therapy; up to 4 months
Secondary outcomes (4)
Average toxicity assessed using the CTCAE
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD. Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The repeated measurements average toxicity will be compared in both study groups.
Measured: Until 8 weeks post radiation therapy; up to 4 months
Time to onset of moist desquamation
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD.Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The time to moist desquamation will be compared in both study groups.
Measured: Until 8 weeks post radiation therapy; up to 4 months
Pain scores
The participant will be asked to rate their pain level at the irradiated area. The time of interest of the original VAS is modified from "the past 24 hours" to "the past 7 days" for the specific purpose of this study. The VAS has been selected as it is a brief and easy tool for the assessment of pain within both the clinical and research settings. It has been well validated in both the chronic pain and cancer settings. The scale of 0 to 10 is simple for patients to use and reflects common clinical assessment of pain.
Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.
Measured: Until 8 weeks post radiation therapy; up to 4 months
Itchiness score
Itching will be scored on a numeric analogue scale of 0-10 in the treated skin (0= no itching at all), (10= itching as bad as you can imagine). Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.
Measured: Until 8 weeks post radiation therapy; up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Nov 2022
- Primary completion30 May 2024
- Study completion30 May 2024
Why it stopped: Protocol deviations and slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553392
- Sponsor's protocol ID
- SPASX018
- Status last verified
- Aug 2024
- First submitted
- 20 Sep 2022
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis in Cancer Patients Receiving Elective Inguinal Radiation Therapy
- ClinicalTrials.gov ID
- NCT05553392
- Acronym / sponsor ID
- SPASX018
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol deviations and slow recruitment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stratpharma AGIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StrataXRT | Experimental | Device: StrataXRTStudied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to both the right and left inguinal regions. The studied products will be used daily during the entire course of radiotherapy including on weekends and holidays until at least 4 weeks upon completion of radiation therapy or otherwise until resolution of RD on both sides. |
| Aquaphor | Active comparator | Drug: AquaphorStudied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to the entire treatment field. The studied products will be used during the entire course of radiotherapy and for a further 4 weeks upon completion of radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy of at least 6 months
- Biopsy-confirmed malignancy without gross nodal involvement of the right or left inguinal regions
- Patients will receive elective radiation therapy to bilateral inguinal nodal regions prescribed to 45-50 Gy in 1.8-2 Gy fractions using photon or proton therapy
Key exclusion criteria (8 listed)
- Patients with gross cancer involvement of either or both inguinal regions.
- Patients who have received prior pelvic and/or inguinal radiation therapy.
- Patients who cannot apply the studied products to the inguinal region or have it administered to them as required by this study.
- Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
- Patients with existing rashes or wounds in either inguinal region at baseline.
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 |
|---|---|---|
| StrataXRTStrataXRT is a full contact flexible wound dressing for the prevention and treatment of radiation dermatitis. StrataXRT is a semi-occlusive, self-drying and transparent gel. When used as directed StrataXRT dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion. StrataXRT may be directly applied to radiation dermatitis, compromised skin surfaces, superficial wounds and first and second degree burns. | Device | StrataXRT |
| AquaphorAquaphor is a brand of over-the-counter (OTC) skin care ointments manufactured by Beiersdorf Inc. Aquaphor contains 41 percent petrolatum (or petroleum jelly), the active ingredient, temporarily protects minor cuts, scrapes, and burns; protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather. | Drug | Aquaphor |
Primary outcome
Incidence of acute >grade 2 radiation dermatitis
Time frame: Until 8 weeks post radiation therapy; up to 4 months
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD (19). This instrument is routinely used and well validated in radiation oncology for assessing radiation dermatitis (20). This weekly assessment will be undertaken by the assessor who is blinded to the allocation. The assessor will be instructed prior to the first fraction of radiation therapy to score the worst toxicity present, at the time of assessment within the treatment field which consists of the bilateral inguinal regions. The amount of > grade 2 RD cases will be compared in both study groups.
4 secondary outcomes
Average toxicity assessed using the CTCAE
Time frame: Until 8 weeks post radiation therapy; up to 4 months
Time to onset of moist desquamation
Time frame: Until 8 weeks post radiation therapy; up to 4 months
Pain scores
Time frame: Until 8 weeks post radiation therapy; up to 4 months
Itchiness score
Time frame: Until 8 weeks post radiation therapy; up to 4 months
Results and safety
The study was stopped early (reason given: Protocol deviations and slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StrataXRT and Aquaphor in people with Radiation Dermatitis, run by Stratpharma AG at 1 site 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Protocol deviations and slow recruitment). Results are not available in the source record.
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?
Incidence of acute >grade 2 radiation dermatitis (time frame: Until 8 weeks post radiation therapy; up to 4 months). 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 4 Sep 2024.