Breast CancerSANDOSTATINENCT03791736
Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation
A study testing Injection of sandostatine in people with Breast Cancer and Lymphocele, run by Institut Cancerologie de l'Ouest.
Trial summary
The lymphocele is the main early postoperative complication of axillary clearance for breast cancer patients with rates up to 85%. The usual treatment consists of external drainage. However, this method increases the duration of hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Lymphocele
- What is being tested?
- Injection of sandostatine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2016to 6 Jul 2018
- 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
- Breast cancer, histologically proven Axillary clearance Elective axillary approach Age ≥ 18 years OMS < 3 Normal hematological and hepatic blood tests Obtaining the signed written consent of the patient
Who cannot join
- Axillary clearance with a mastectomy Metastatic disease Disorder precluding understanding of trial information or informed consent Pregnancy, breastfeeding women Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations No severe or uncontrolled diabetes Known hypersensitivity to Octreotide Patient with vitamin B12 deficiency Anticoagulant treatment History of cardiovascular disease Other product being tested in the 4 weeks prior to the start of treatment Patient has valid health insurance
About this study
Official title: Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation In Patients With Breast Cancer
The lymphocele is the main early postoperative complication of axillary clearance for breast cancer patients with rates up to 85%.
The usual treatment consists of external drainage. However, this method increases the duration of hospitalization.
Read more
As a result, some practitioners have abandoned drainage, allowing for ambulatory surgery.
If this solution makes it possible to reduce the duration of the hospitalizations, it involves iterative punctures of the axillary hollow in case of lymphocele These punctures may be responsible for pain, hematoma or infection of the operative site.
To date, no method has proved superior in terms of decreasing the incidence of lymphocele postoperatively axillary clearance.
Octreotide (Sandostatin®) is a peptide, one of whose effects is to reduce the inflammation responsible for lymphoceles.
The aim of the study is to inject Sandostatin® before surgery, with the aim of reducing the incidence of seroma by 50% after axillary clearance
- Conditions
- Breast Cancer, Lymphocele
- Being tested
- Injection of sandostatine
- Keywords
- breast cancer, axillary clearance, lymphocele
- Medical subject headings
- Breast Neoplasms, Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of sandostatineProcedure or surgery
Also called Octreotide
Intramuscular injection of sandostatin 30 mg 3 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| Sandostatine | Experimental | Injection of Sandostatine Receives: Procedure: Injection of sandostatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
A 50% decrease in the incidence of lymphocele (30% to 15% progression) following axillary clearance of patients operated for breast cancer (excluding mastectomy) pretreated with an injection of Sandostatin®.
The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.
Measured: 6 months
Secondary outcomes (2)
Evaluation of the volume of the punctures
Determined by the volume of the punctures carried out
Measured: 6 months
Evaluation of the cost of this treatment
Determined by the data recovered from the Health Insurance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start6 Jul 2016
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Why it stopped: The surgical technique is no longer used
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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A phase II prospective, single-center, non-randomized study.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMMANUELLE MARTIN, MD, Study director, INSTITUT DE CANCEROLOGIE DE L'OUEST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791736
- Sponsor's protocol ID
- 2015-03
- Acronym
- SANDOSTATINE
- Status last verified
- Jul 2022
- First submitted
- 31 Dec 2018
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation In Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT03791736
- Acronym / sponsor ID
- SANDOSTATINE / 2015-03
- Conditions
- Breast Cancer, Lymphocele
- Keywords
- breast cancer, axillary clearance, lymphocele
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The surgical technique is no longer used
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 3 Jan 2019 (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.
The lymphocele is the main early postoperative complication of axillary clearance for breast cancer patients with rates up to 85%.
The usual treatment consists of external drainage. However, this method increases the duration of hospitalization.
As a result, some practitioners have abandoned drainage, allowing for ambulatory surgery.
If this solution makes it possible to reduce the duration of the hospitalizations, it involves iterative punctures of the axillary hollow in case of lymphocele These punctures may be responsible for pain, hematoma or infection of the operative site.
To date, no method has proved superior in terms of decreasing the incidence of lymphocele postoperatively axillary clearance.
Octreotide (Sandostatin®) is a peptide, one of whose effects is to reduce the inflammation responsible for lymphoceles.
The aim of the study is to inject Sandostatin® before surgery, with the aim of reducing the incidence of seroma by 50% after axillary clearance
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A phase II prospective, single-center, non-randomized study.
| Arm | Type | Receives |
|---|---|---|
| Sandostatine | Experimental | Procedure: Injection of sandostatineInjection of Sandostatine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer, histologically proven Axillary clearance Elective axillary approach Age ≥ 18 years OMS < 3 Normal hematological and hepatic blood tests Obtaining the signed written consent of the patient
Key exclusion criteria (1 listed)
- Axillary clearance with a mastectomy Metastatic disease Disorder precluding understanding of trial information or informed consent Pregnancy, breastfeeding women Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations No severe or uncontrolled diabetes Known hypersensitivity to Octreotide Patient with vitamin B12 deficiency Anticoagulant treatment History of cardiovascular disease Other product being tested in the 4 weeks prior to the start of treatment Patient has valid health insurance
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 |
|---|---|---|
| Injection of sandostatineAlso: OctreotideIntramuscular injection of sandostatin 30 mg 3 days before surgery | Procedure or surgery | Sandostatine |
Primary outcome
A 50% decrease in the incidence of lymphocele (30% to 15% progression) following axillary clearance of patients operated for breast cancer (excluding mastectomy) pretreated with an injection of Sandostatin®.
Time frame: 6 months
The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.
2 secondary outcomes
Evaluation of the volume of the punctures
Time frame: 6 months
Evaluation of the cost of this treatment
Time frame: 6 months
Results and safety
The study was stopped early (reason given: The surgical technique is no longer used). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
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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.
EMMANUELLE MARTIN, MD study director
INSTITUT DE CANCEROLOGIE DE L'OUEST
Questions about this trial
What is this clinical trial studying?
A study testing Injection of sandostatine in people with Breast Cancer and Lymphocele, run by Institut Cancerologie de l'Ouest.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 stopped early (reason given: The surgical technique is no longer used). Results are not available in the source record.
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?
A 50% decrease in the incidence of lymphocele (30% to 15% progression) following axillary clearance of patients operated for breast cancer (excluding mastectomy) pretreated with an injection of Sandostatin®. (time frame: 6 months). 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 28 Jul 2022.