Breast CancerPhase 2NCT02447211
Topical Doxepin for Radiation-induced Dermatitis
A Phase 2 study testing Doxepin cream 5% in people with Breast Cancer, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Radiation dermatitis is one of the most common side effects of radiotherapy approximately occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear and mitochondrial DNA, and initiation of an… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Doxepin cream 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- May 2015to Jan 2019
- Phase
- Phase 2
- 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 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female with a diagnosis of, breast adenocarcinoma and be referred for post-operative radiotherapy with or without concurrent chemotherapy and with or without mastectomy
- Participants must not be pregnant.
- Participants treated with a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week
Who cannot join
- Patients who are not eligible
- The presence of skin diseases in the radiation area
- Patients have constipation, xerostomia, blurred vision, urinary retention
- Hypersensitivity to doxepin
Trial locations and contacts
1 site in 1 country.
Alireza Amouheidari, MD contact
Iran1 site, 1 recruiting
- Recruiting
Isfahan University of Medical Sciences
Isfahan, 81745-319
Golnaz Vaseghi, Ph.D, golnazvaseghi@yahoo.com
Alireza Amouheidari, MD, amouheidari@yahoo.com
About this study
Official title: Topical Doxepin for Prevention and Management of Radiation-induced Dermatitis
Radiation dermatitis is one of the most common side effects of radiotherapy approximately occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and dermis occurs within hours to weeks after radiation exposure. Radiation dermatitis due to pain and discomfort has an adverse impact on the quality of a patient's life.The radiation toxicities such as radiation dermatitis encountered in clinical practice are typically managed with a variety of topical agents such as water-based moisturizing creams or lotions, topical steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic interventions for the prevention and treatment of these toxicity can be used to protect skin against radiation damage.Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness.The aim of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of topical doxepin for the prevention and management of radiation-induced dermatitis during postoperative radiotherapy for breast cancer.
Read the detailed description
The patients who have undergone breast surgery and require radiotherapy and fulfill the inclusion criteria of the study will be entered the study. All the patients will be treated by 3D conformal radiation therapy using CT -based treatment planning and multi leaf linear accelerators. The patients will be treated by conventional fractionation regimens to a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week). Every week the patients will be visited by an experienced radiation oncologist and the skin reaction will be determined and recorded according to RTOG Acute Radiation Morbidity Scoring Criteria which scores from 0 to 4. The patients receive Doxepin cream at the beginning of 5th week of radiotherapy and use it for a whole week. After acquiring written permission, the radiotherapy site will be photographed at the start and ending of the Doxepin
- Conditions
- Breast Cancer
- Being tested
- Doxepin cream 5%, Placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxepin cream 5%Drug
Patients use doxepin creamtwice daily for one weeks
PlaceboOther
Patients use cream without doxepin ingredient twice daily for one weeks
| Study group | Role | What they receive |
|---|---|---|
| doxepin cream | Active comparator | Patients use doxepin cream 5% twice daily for two weeks Receives: Drug: Doxepin cream 5% |
| Placebo | Placebo comparator | Patients use cream without doxepin ingredient twice daily for two weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria
at the beginning of 5th week of radiotherapy and use it for two weeks
Measured: At the beginning of 5th week of radiotherapy to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2019
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Golnaz Vaseghi, Isfahan University of Medical Sciences
- Investigators
- Golnaz Vaseghi, Ph.D, Principal investigator, Applied Physiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, IranAlireza Amouheidari, MD, Principal investigator, Head, Department of Radiation Oncology,Isfahan Milad Hospital, Isfahan,IranLaleh Shariati, Ph.D, Principal investigator, Isfahan University of Medical SciencesShaghayegh Shaghayegh Haghjoo-Javanmard, Ph.D, Study director, Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, IranHajar Naji, M.S, Study chair, Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447211
- Sponsor's protocol ID
- 900
- Status last verified
- Jan 2019
- First submitted
- 14 May 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Doxepin for Prevention and Management of Radiation-induced Dermatitis
- ClinicalTrials.gov ID
- NCT02447211
- Acronym / sponsor ID
- 900
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (estimated)
- First posted
- 18 May 2015 (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.
Radiation dermatitis is one of the most common side effects of radiotherapy approximately occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and dermis occurs within hours to weeks after radiation exposure. Radiation dermatitis due to pain and discomfort has an adverse impact on the quality of a patient's life.The radiation toxicities such as radiation dermatitis encountered in clinical practice are typically managed with a variety of topical agents such as water-based moisturizing creams or lotions, topical steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic interventions for the prevention and treatment of these toxicity can be used to protect skin against radiation damage.Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness.The aim of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of topical doxepin for the prevention and management of radiation-induced dermatitis during postoperative radiotherapy for breast cancer.
Detailed description
The patients who have undergone breast surgery and require radiotherapy and fulfill the inclusion criteria of the study will be entered the study. All the patients will be treated by 3D conformal radiation therapy using CT -based treatment planning and multi leaf linear accelerators. The patients will be treated by conventional fractionation regimens to a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week). Every week the patients will be visited by an experienced radiation oncologist and the skin reaction will be determined and recorded according to RTOG Acute Radiation Morbidity Scoring Criteria which scores from 0 to 4. The patients receive Doxepin cream at the beginning of 5th week of radiotherapy and use it for a whole week. After acquiring written permission, the radiotherapy site will be photographed at the start and ending of the Doxepin
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxepin cream | Active comparator | Drug: Doxepin cream 5%Patients use doxepin cream 5% twice daily for two weeks |
| Placebo | Placebo comparator | Other: PlaceboPatients use cream without doxepin ingredient twice daily for two weeks |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female with a diagnosis of, breast adenocarcinoma and be referred for post-operative radiotherapy with or without concurrent chemotherapy and with or without mastectomy
- Participants must not be pregnant.
- Participants treated with a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week
Key exclusion criteria (4 listed)
- Patients who are not eligible
- The presence of skin diseases in the radiation area
- Patients have constipation, xerostomia, blurred vision, urinary retention
- Hypersensitivity to doxepin
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 |
|---|---|---|
| Doxepin cream 5%Patients use doxepin creamtwice daily for one weeks | Drug | doxepin cream |
| PlaceboPatients use cream without doxepin ingredient twice daily for one weeks | Other | Placebo |
Primary outcome
Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria
Time frame: At the beginning of 5th week of radiotherapy to two weeks
at the beginning of 5th week of radiotherapy and use it for two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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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.
Alireza Amouheidari, MD contact
Golnaz Vaseghi, Ph.D principal investigator
Applied Physiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
Alireza Amouheidari, MD principal investigator
Head, Department of Radiation Oncology,Isfahan Milad Hospital, Isfahan,Iran
Laleh Shariati, Ph.D principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxepin cream 5% in people with Breast Cancer, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Jan 2019. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Golnaz Vaseghi, Ph.D (0989133259802, golnazvaseghi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria (time frame: At the beginning of 5th week of radiotherapy to two weeks). 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 16 Jan 2019.