Ductal Breast Carcinoma in SituNCT02168179
KeraStat Skin Therapy in Treating Radiation Dermatitis in Patients With Newly Diagnosed Stage 0-IIIA Breast Cancer
A study testing dermatologic complications management/prevention and questionnaire administration in people with Ductal Breast Carcinoma in Situ and Skin Reactions Secondary to Radiation Therapy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma in Situ, Skin Reactions Secondary to Radiation Therapy, Stage IA Breast Cancer
- What is being tested?
- dermatologic complications management/prevention and questionnaire administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jul 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with breast carcinoma, stage 0-IIIA (including ductal carcinoma in situ [DCIS])
- Status post-lumpectomy, -quadrantectomy, or -mastectomy
- Plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes
- Total dose >= 40Gy
- Dose per fraction >= 1.8 use of 2-dimensional (2D), 3-dimensional (3D) conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; skin sparing IMRT patients excluded; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens
- Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
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- Adjuvant hormonal therapy will be allowed prior to, during and/or after RT at the discretion of a medical oncologist
- Targeted therapies such as Herceptin will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist
- Patients who are able and willing to sign protocol consent form
Who cannot join
- Prior radiation to the involved breast or chest wall
- Concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion)
- Patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed)
- Patients undergoing partial breast irradiation
- Patients who have undergone MammoSite® or any other form of brachytherapy
- Patients may not be concurrently enrolled in a protocol that involves treatment of the skin ie: applying lotions /moisturizers; protocols that do not involve treatment of the skin are allowed
- Patients who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Safety of Treatment With KeraStat Skin Therapy in Breast Cancer Patients Developing Radiation Dermatitis
This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy may be a better treatment for radiation dermatitis.
Read the detailed description
PRIMARY OBJECTIVES:
- To obtain a preliminary estimate the incidence of early adverse skin reaction (EASR) during radiation therapy (RT) and up to two months post RT after the application of the cosmetic cream KeraStat Skin Therapy during RT in breast cancer patients in a pilot study.
SECONDARY OBJECTIVES:
- To associate personal characteristics (e.g., race/ethnicity, age, hormone therapy, smoking status, comorbidities, breast size) and treatment characteristics (e.g., RT dose) to incidence of EASR at any time point.
OUTLINE:
Patients apply KeraStat Skin Therapy topically twice daily (BID) during radiation therapy.
After completion of study treatment, patients are followed up at 1 and 2 months.
- Conditions
- Ductal Breast Carcinoma in Situ, Skin Reactions Secondary to Radiation Therapy, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Being tested
- dermatologic complications management/prevention, questionnaire administration
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dermatologic complications management/preventionProcedure or surgery
Also called complications management/prevention, dermatologic, management/prevention, dermatologic complications
Apply KeraStat Skin Therapy topically
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (KeraStat Skin Therapy) | Experimental | Patients apply KeraStat Skin Therapy topically BID during radiation therapy. Receives: Procedure: dermatologic complications management/prevention; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any RT-induced EASR defined as a grade 4 or higher toxicity using the Modified Oncology Nursing Society Criteria for Radiation-Induced Acute Skin Toxicity
At each time point the proportion of women who have RT-induced EASR present will be estimated and a 95% confidence interval will be calculated around this estimate.
Measured: Up to 2 months after completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: No longer pursuing study at our site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Breast Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arthur Blackstock, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168179
- Sponsor's protocol ID
- IRB00028009
- Other IDs
- NCI-2014-01274, CCCWFU 98114, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 18 Jun 2014
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Treatment With KeraStat Skin Therapy in Breast Cancer Patients Developing Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT02168179
- Acronym / sponsor ID
- IRB00028009
- Conditions
- Ductal Breast Carcinoma in Situ, Skin Reactions Secondary to Radiation Therapy, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer pursuing study at our site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Jun 2014 (estimated)
- 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 pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy may be a better treatment for radiation dermatitis.
Detailed description
PRIMARY OBJECTIVES:
- To obtain a preliminary estimate the incidence of early adverse skin reaction (EASR) during radiation therapy (RT) and up to two months post RT after the application of the cosmetic cream KeraStat Skin Therapy during RT in breast cancer patients in a pilot study.
SECONDARY OBJECTIVES:
- To associate personal characteristics (e.g., race/ethnicity, age, hormone therapy, smoking status, comorbidities, breast size) and treatment characteristics (e.g., RT dose) to incidence of EASR at any time point.
OUTLINE:
Patients apply KeraStat Skin Therapy topically twice daily (BID) during radiation therapy.
After completion of study treatment, patients are followed up at 1 and 2 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (KeraStat Skin Therapy) | Experimental | Procedure: dermatologic complications management/prevention, Other: questionnaire administrationPatients apply KeraStat Skin Therapy topically BID during radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed with breast carcinoma, stage 0-IIIA (including ductal carcinoma in situ [DCIS])
- Status post-lumpectomy, -quadrantectomy, or -mastectomy
- Plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes
- Total dose >= 40Gy
- Dose per fraction >= 1.8 use of 2-dimensional (2D), 3-dimensional (3D) conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; skin sparing IMRT patients excluded; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens
Key exclusion criteria (7 listed)
- Prior radiation to the involved breast or chest wall
- Concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion)
- Patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed)
- Patients undergoing partial breast irradiation
- Patients who have undergone MammoSite® or any other form of brachytherapy
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 |
|---|---|---|
| dermatologic complications management/preventionAlso: complications management/prevention, dermatologic, management/prevention, dermatologic complicationsApply KeraStat Skin Therapy topically | Procedure or surgery | Supportive Care (KeraStat Skin Therapy) |
| questionnaire administrationAncillary studies | Other | Supportive Care (KeraStat Skin Therapy) |
Primary outcome
Occurrence of any RT-induced EASR defined as a grade 4 or higher toxicity using the Modified Oncology Nursing Society Criteria for Radiation-Induced Acute Skin Toxicity
Time frame: Up to 2 months after completion of radiation therapy
At each time point the proportion of women who have RT-induced EASR present will be estimated and a 95% confidence interval will be calculated around this estimate.
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 5 Jul 2018.
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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.
Arthur Blackstock principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dermatologic complications management/prevention and questionnaire administration in people with Ductal Breast Carcinoma in Situ and Skin Reactions Secondary to Radiation Therapy, run by Wake Forest University Health Sciences 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 7 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 5 Jul 2018. 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?
Occurrence of any RT-induced EASR defined as a grade 4 or higher toxicity using the Modified Oncology Nursing Society Criteria for Radiation-Induced Acute Skin Toxicity (time frame: Up to 2 months after completion of radiation therapy). 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 5 Jul 2018.