Breast CarcinomaNCT05073172
StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients
A study testing Calendula Ointment, Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment and Polyethylene Glycol Hydrogel in people with Breast Carcinoma and Head and Neck Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Head and Neck Carcinoma, Radiation-Induced Dermatitis
- What is being tested?
- Calendula Ointment, Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment and Polyethylene Glycol Hydrogel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Jul 2025
- 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
- Patients will be adult (> age of 18) patients. Both men and women and members of all races and ethnic groups will be included
- Histologically confirmed malignancy for which standard curative measures in conjunction with radiotherapy are indicated to the following sites: whole breast/chest-wall for post-surgical radiotherapy or bilateral neck (levels one through six) for head and neck cancer
- All head and neck cancer patients should have the left and right neck treated to the same dose when receiving bilateral neck irradiation
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Clinically evident skin involvement of malignancy
- Thin patients with nodal involvement requiring bolus
- Patients with significant unshaven facial or chest wall hair compromising film application
- Evidence of active cellulitis or wound infection involving anticipated treatment site
- History of prior radiotherapy to involved site within 5 cm of anticipated treatment field
- Eastern Cooperative Oncology Group (ECOG) performance status >= 3
Show all 13Show fewer
- Patients receiving concurrent capecitabine
- Patient with skin grafts over treatment site(s)
- Presence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. (i.e. schizophrenia, autism, temporary housing during treatment, scheduling conflict immediately after treatment. This will need to be assessed prior to consent
- Actual or perceived inability to reliably apply StrataXRT to the patients treatment field in the home environment
- Anticipated or actual use of other non-study topical medications or remedies in the treatment field
- Vulnerable populations (pregnant women, decisionally impaired adults, and prisoners) will be excluded from the study
- Patients receiving ultra-hypofractionated radiation to the breast
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Randomized Intra-Patient Controlled Study of StrataXRT ® Versus Current Practice to Prevent and Treat Radiation Dermatitis
This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.
Read the detailed description
PRIMARY OBJECTIVE:
- Compare efficacy of silicone-based film forming topical gel (StrataXRT) versus (vs.) standard of care skin maintenance.
SECONDARY OBJECTIVES:
- Evaluate overall effectiveness of StrataXRT. II. Evaluate post-radiation therapy (RT) recovery time for StrataXRT compared to standard of care.
EXPLORATORY OBJECTIVES:
- To assess patient reported outcomes. II. Evaluate cost of StrataXRT for management of radiation dermatitis compared to standard of care skin maintenance.
III. Evaluate the reduction in RT interruption/extension of overall duration of receiving RT based on the reduced skin toxicity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1.
ARM II: Patients receive standard of care including calendula and/or petrolatum-mineral oil-lanolin-ceresin ointment (Aquaphor) applied 2-6 times daily plus hydrogel or silver sulfadiazine (Silvadene) or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1.
After completion of study, patients are followed up at 6 days and 3 weeks post-RT.
- Being tested
- Calendula Ointment, Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment, Polyethylene Glycol Hydrogel, Silicone-based Film Forming Topical Gel, Silver Sulfadiazine
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calendula OintmentDrug
Applied topically
Petrolatum-Mineral Oil-Lanolin-Ceresin OintmentOther
Also called Aquaphor
Applied topically
Polyethylene Glycol HydrogelOther
Also called PEG Hydrogel
Applied topically
Silicone-based Film Forming Topical GelDrug
Also called Silicone-based Film-forming Gel Dressing, StrataCTX, StrataXRT, StrataXRT Gel
Applied topically
Silver SulfadiazineDrug
Also called Flamazine, Silvadene, Sliverex, SSD
Applied topically
Topical HydrocortisoneDrug
Applied topically
| Study group | Role | What they receive |
|---|---|---|
| Arm I (StrataXRT) | Experimental | Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1. Receives: Drug: Silicone-based Film Forming Topical Gel |
| Arm II (standard of care) | Active comparator | Patients receive standard of care including calendula and/or Aquaphor applied 2-6 times daily plus hydrogel or Silvadene or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1. Receives: Drug: Calendula Ointment; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Other: Polyethylene Glycol Hydrogel; Drug: Silver Sulfadiazine; Drug: Topical Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dermatitis
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Day 0 post-radiation therapy (RT)
Secondary outcomes (5)
Grade 2+ radiation dermatitis
Will be assessed by CTCAE version 5.0.
Measured: Day 0 post-RT
Grade 2+ radiation dermatitis
Will be assessed by CTCAE version 5.0.
Measured: Day 6 +/- 1 post-RT
Weekly Common Terminology Criteria for Adverse Events (CTCAE) scores
Will continue to assess CTCAE score for radiation dermatitis until resolution of symptoms.
Measured: Up to week 3 post-RT
Time to peak Common Terminology Criteria for Adverse Events (CTCAE) score
Measured: Up to week 3 post-RT
Post-RT recovery time (to grade =< 1 radiation dermatitis
Will be defined by Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Up until entire irradiated treatment site healed (grade =< 1 dermatitis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Why it stopped: study staff transition
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Josh Walker, M.D., Ph.D., OHSU Knight Cancer Institute
- Investigators
- Josh Walker, M.D., Ph.D., Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073172
- Sponsor's protocol ID
- STUDY00018789
- Other IDs
- NCI-2021-09431, STUDY00018789
- Status last verified
- May 2024
- First submitted
- 16 Sep 2021
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Intra-Patient Controlled Study of StrataXRT ® Versus Current Practice to Prevent and Treat Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT05073172
- Acronym / sponsor ID
- STUDY00018789
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study staff transition
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 11 Oct 2021 (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.
This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.
Detailed description
PRIMARY OBJECTIVE:
- Compare efficacy of silicone-based film forming topical gel (StrataXRT) versus (vs.) standard of care skin maintenance.
SECONDARY OBJECTIVES:
- Evaluate overall effectiveness of StrataXRT. II. Evaluate post-radiation therapy (RT) recovery time for StrataXRT compared to standard of care.
EXPLORATORY OBJECTIVES:
- To assess patient reported outcomes. II. Evaluate cost of StrataXRT for management of radiation dermatitis compared to standard of care skin maintenance.
III. Evaluate the reduction in RT interruption/extension of overall duration of receiving RT based on the reduced skin toxicity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1.
ARM II: Patients receive standard of care including calendula and/or petrolatum-mineral oil-lanolin-ceresin ointment (Aquaphor) applied 2-6 times daily plus hydrogel or silver sulfadiazine (Silvadene) or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1.
After completion of study, patients are followed up at 6 days and 3 weeks post-RT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (StrataXRT) | Experimental | Drug: Silicone-based Film Forming Topical GelPatients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1. |
| Arm II (standard of care) | Active comparator | Drug: Calendula Ointment, Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment, Other: Polyethylene Glycol Hydrogel, Drug: Silver Sulfadiazine, Drug: Topical HydrocortisonePatients receive standard of care including calendula and/or Aquaphor applied 2-6 times daily plus hydrogel or Silvadene or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients will be adult (> age of 18) patients. Both men and women and members of all races and ethnic groups will be included
- Histologically confirmed malignancy for which standard curative measures in conjunction with radiotherapy are indicated to the following sites: whole breast/chest-wall for post-surgical radiotherapy or bilateral neck (levels one through six) for head and neck cancer
- All head and neck cancer patients should have the left and right neck treated to the same dose when receiving bilateral neck irradiation
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (13 listed)
- Clinically evident skin involvement of malignancy
- Thin patients with nodal involvement requiring bolus
- Patients with significant unshaven facial or chest wall hair compromising film application
- Evidence of active cellulitis or wound infection involving anticipated treatment site
- History of prior radiotherapy to involved site within 5 cm of anticipated treatment field
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 |
|---|---|---|
| Calendula OintmentApplied topically | Drug | Arm II (standard of care) |
| Petrolatum-Mineral Oil-Lanolin-Ceresin OintmentAlso: AquaphorApplied topically | Other | Arm II (standard of care) |
| Polyethylene Glycol HydrogelAlso: PEG HydrogelApplied topically | Other | Arm II (standard of care) |
| Silicone-based Film Forming Topical GelAlso: Silicone-based Film-forming Gel Dressing, StrataCTX, StrataXRT, StrataXRT GelApplied topically | Drug | Arm I (StrataXRT) |
| Silver SulfadiazineAlso: Flamazine, Silvadene, Sliverex, SSDApplied topically | Drug | Arm II (standard of care) |
| Topical HydrocortisoneApplied topically | Drug | Arm II (standard of care) |
Primary outcome
Radiation dermatitis
Time frame: Day 0 post-radiation therapy (RT)
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE).
5 secondary outcomes
Grade 2+ radiation dermatitis
Time frame: Day 0 post-RT
Grade 2+ radiation dermatitis
Time frame: Day 6 +/- 1 post-RT
Weekly Common Terminology Criteria for Adverse Events (CTCAE) scores
Time frame: Up to week 3 post-RT
Time to peak Common Terminology Criteria for Adverse Events (CTCAE) score
Time frame: Up to week 3 post-RT
Post-RT recovery time (to grade =< 1 radiation dermatitis
Time frame: Up until entire irradiated treatment site healed (grade =< 1 dermatitis)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Josh Walker, M.D., Ph.D. principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calendula Ointment, Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment and Polyethylene Glycol Hydrogel in people with Breast Carcinoma and Head and Neck Carcinoma, run by OHSU Knight Cancer Institute 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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 6 May 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 withdrawn before enrolling participants, so there are no results.
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: Day 0 post-radiation therapy (RT)). 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 6 May 2024.