LymphocelePhase 3NCT00630695
Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer
A Phase 3 study testing Lanreotide LP 90 in people with Lymphocele, run by University Hospital, Limoges at 1 site in France.
Trial summary
Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Lymphocele
- What is being tested?
- Lanreotide LP 90
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Dec 2011
- Phase
- Phase 3
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (> 18 years),
- Patient undergoing an axillary lymphadenectomy for breast cancer
- Patient giving her agreement after being informed
Who cannot join
- Patients that don't understand the trial
- Type 2 diabetic patients
- Cyclosporine treatment
- Biliary lithiasis
- Pregnancy or breast feeding
- Allergic reaction to Lanréotide or same class treatments
- Patient included in another trial within the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer
Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study
Read the detailed description
Patients will be recruited among patient refered to our department for a breast cancer and needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or placebo the day before surgery when they arrive in their room. The quantity of lymph in axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and M6 for pain, lymphocele and adverse events.
Data will be compared in the 2 groups.
- Conditions
- Lymphocele
- Being tested
- Lanreotide LP 90, Placebo lanreotide
- Keywords
- Axillary lymphocele breast cancer
- Medical subject headings
- Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide LP 90Drug
Lanreotide LP 90
Placebo lanreotideDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lanreotide LP 90 Receives: Drug: Lanreotide LP 90 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo lanreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of lymph collected by the drain
Measured: D4 post operativly
Secondary outcomes (1)
Prevention of lymphocele
Measured: D15, D30 and M6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphoceleStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Investigators
- Yves Aubard, MD, PhD, Study chair, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630695
- Sponsor's protocol ID
- 2007-003576-19
- Status last verified
- Jan 2012
- First submitted
- 27 Feb 2008
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer
- ClinicalTrials.gov ID
- NCT00630695
- Acronym / sponsor ID
- 2007-003576-19
- Conditions
- Lymphocele
- Keywords
- Axillary lymphocele breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Mar 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Mar 2008 (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.
Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study
Detailed description
Patients will be recruited among patient refered to our department for a breast cancer and needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or placebo the day before surgery when they arrive in their room. The quantity of lymph in axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and M6 for pain, lymphocele and adverse events.
Data will be compared in the 2 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lanreotide LP 90Lanreotide LP 90 |
| 2 | Placebo comparator | Drug: Placebo lanreotide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient (> 18 years),
- Patient undergoing an axillary lymphadenectomy for breast cancer
- Patient giving her agreement after being informed
Key exclusion criteria (7 listed)
- Patients that don't understand the trial
- Type 2 diabetic patients
- Cyclosporine treatment
- Biliary lithiasis
- Pregnancy or breast feeding
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 |
|---|---|---|
| Lanreotide LP 90Lanreotide LP 90 | Drug | 1 |
| Placebo lanreotidePlacebo | Drug | 2 |
Primary outcome
Quantity of lymph collected by the drain
Time frame: D4 post operativly
1 secondary outcome
Prevention of lymphocele
Time frame: D15, D30 and M6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
Related trials for Lymphocele
Recruiting
Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
Lymphocele
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.
Yves Aubard, MD, PhD study chair
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lanreotide LP 90 in people with Lymphocele, run by University Hospital, Limoges at 1 site in France.
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 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: finished, as of the sponsor's last update on 16 Jan 2012. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantity of lymph collected by the drain (time frame: D4 post operativly). 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 2012.