RadiodermatitisPhase 2NCT00445250
The Role of Calcipotriol as Radioprotector of Skin
A Phase 2 study testing Calcipotriol in people with Radiodermatitis, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast. To check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus, use of medications… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Radiodermatitis
- What is being tested?
- Calcipotriol
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranging from 18 to 75.
- Confirmed histological diagnosis of Breast cancer.
- Radiotherapy treatment to the breast following lumpectomy.
Who cannot join
- Scleroderma.
- An extremely large breast. Interfiled above 25 cm.
- Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.
- Mastectomy.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center
Petach Tiqva, 49100
Eyal Fenig, M.D., 97239377964, efenig@clalit.org.il
Ofer Purim, M.D., 97239377973, oferp@clalit.org.il
About this study
Official title: Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast.
Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast.
To check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus, use of medications, allergies, weight, habits, size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.
Read the detailed description
STUDY PROTOCOL
Fifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy, will participate in the study. About 15 minutes after receiving the daily radiation dose fraction, a cream containing an active vitamin D analogue will be applied to half of the breast with inspection of a nurse. The other half of the breast will have a standard cream applied . During the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy (e.g. strong erythema, painful tenderness etc.)The adverse skin effects will be assessed according to the following criteria:
- . an assessment by a physician and a nurse according to the RTOG score (6). As follows: Grade 0 - no reaction. Grade 1 - light erythema dry peeling, decrease in sweat production. Grade 3 - extensive moist peeling, pitting edema. Grade 4 - ulcers, bleeding and necrosis.
- . A questionnaire to each patient regarding the efficacy and safety of the cream.
- . Number of interruption of radiotherapy treatment. The assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment.
Safety report will be sent to the local independent ethics committee after the examination of the first ten patients.
The protective effect of the cream containing calcipotriol will be compared to the standard treatment and analyzed statistically using the parameters mention above. The relation between the background disease, medications, allergies, weight, habits, size of the irradiated breast, sun exposure, previous chemotherapy treatment and exposure to sunlight and the skin reaction will be evaluated.
INCLUSION CRITERIA
- . Age ranging from 18 to 75.
- . Confirmed histological diagnosis of Breast cancer.
- . Radiotherapy treatment to the breast following lumpectomy.
EXCLUSION CRITERIA
- . Scleroderma.
- . An extremely large breast. Interfiled above 25 cm.
- . Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.
- . Mastectomy.
- Conditions
- Radiodermatitis
- Being tested
- Calcipotriol
- Keywords
- Calcipotriol, Breast, Cancer, Radiotherapy, Radiodermatitis in Breast Cancer
- Medical subject headings
- Radiodermatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcipotriolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of radiodermatitis
Secondary outcomes (1)
Side effects of Calcipotriol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiodermatitisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Eyal Fenig, M.D., Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445250
- Sponsor's protocol ID
- 004253
- Status last verified
- Jan 2007
- First submitted
- 7 Mar 2007
- Last updated
- 8 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast.
- ClinicalTrials.gov ID
- NCT00445250
- Acronym / sponsor ID
- 004253
- Conditions
- Radiodermatitis
- Keywords
- Calcipotriol, Breast, Cancer, Radiotherapy, Radiodermatitis in Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- First posted
- 8 Mar 2007 (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.
Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast.
To check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus, use of medications, allergies, weight, habits, size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.
Detailed description
STUDY PROTOCOL
Fifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy, will participate in the study. About 15 minutes after receiving the daily radiation dose fraction, a cream containing an active vitamin D analogue will be applied to half of the breast with inspection of a nurse. The other half of the breast will have a standard cream applied . During the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy (e.g. strong erythema, painful tenderness etc.)The adverse skin effects will be assessed according to the following criteria:
- . an assessment by a physician and a nurse according to the RTOG score (6). As follows: Grade 0 - no reaction. Grade 1 - light erythema dry peeling, decrease in sweat production. Grade 3 - extensive moist peeling, pitting edema. Grade 4 - ulcers, bleeding and necrosis.
- . A questionnaire to each patient regarding the efficacy and safety of the cream.
- . Number of interruption of radiotherapy treatment. The assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment.
Safety report will be sent to the local independent ethics committee after the examination of the first ten patients.
The protective effect of the cream containing calcipotriol will be compared to the standard treatment and analyzed statistically using the parameters mention above. The relation between the background disease, medications, allergies, weight, habits, size of the irradiated breast, sun exposure, previous chemotherapy treatment and exposure to sunlight and the skin reaction will be evaluated.
INCLUSION CRITERIA
- . Age ranging from 18 to 75.
- . Confirmed histological diagnosis of Breast cancer.
- . Radiotherapy treatment to the breast following lumpectomy.
EXCLUSION CRITERIA
- . Scleroderma.
- . An extremely large breast. Interfiled above 25 cm.
- . Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.
- . Mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ranging from 18 to 75.
- Confirmed histological diagnosis of Breast cancer.
- Radiotherapy treatment to the breast following lumpectomy.
Key exclusion criteria (4 listed)
- Scleroderma.
- An extremely large breast. Interfiled above 25 cm.
- Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.
- Mastectomy.
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 |
|---|---|---|
| Calcipotriol | Drug | – |
Primary outcome
Prevention of radiodermatitis
1 secondary outcome
Side effects of Calcipotriol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2007.
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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.
Eyal Fenig, M.D. principal investigator
Rabin Medical Center
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 Calcipotriol in people with Radiodermatitis, run by Rabin Medical Center at 1 site in Israel.
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 8 Mar 2007. 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 Israel. 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.
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 Eyal Fenig, M.D. (97239377964, efenig@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of radiodermatitis. 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 8 Mar 2007.