SeromaPhase 2NCT02668588
Extended-release of Octreotide (LF-PB) for the Treatment of Seroma
A Phase 2 study testing extended release of octreotide in people with Seroma, run by Chemi S.p.A. at 7 sites in Italy.
Trial summary
This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND). Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Seroma
- What is being tested?
- extended release of octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 7 sitesItaly
- Study dates
- 22 Oct 2015to 19 Jul 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Undergoing breast cancer surgery with axillary lymph node dissection during the current clinical trial;
- Negative serum pregnancy test for women of childbearing potential;
- Aspartate aminotransferase and alanine aminotransferase < 2 x the upper limit of normal;
- ECOG PS ≤ 1.
Who cannot join
- Previous axillary surgery on the same armpit (sentinel lymph node surgery is not exclusionary);
- Previous radiotherapy within five years from study drug administration on the same armpit undergoing surgery in this study;
- Concomitant participation to other clinical trial;
- Uncontrolled diabetes;
- Cholelithiasis;
- Human immunodeficiency virus or hepatitis B or C by screening serology;
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- Uncontrolled hypothyroidism: if patient is being administered Eutirox/ Levothyroxine (or analogues) and levels of T3, T4 and TSH are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study;
- Pregnant or lactating;
- Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation;
- Corrected QT (using the Bazett formula, QTc) interval at screening or baseline > 450 msec (as the mean of 3 consecutive readings 5 minutes apart);
- Presence of any disease or use of concomitant medication known to increase the QT interval;
- Clinically significant or relevant abnormal medical history, vital sign, physical examination or laboratory evaluation finding;
- Corticosteroid treatment on a long-term basis (i.e. treatment for more than 3 consecutive days);
- Current or recurrent disease that could affect the results of the clinical or laboratory assessment required for the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Az. Osp. Univ. Mater Domini
Catanzaro, Calabria, 88100
Az. Osp. Univ. di Ferrara - Ospedale di Cona
Ferrara, Emilia-Romagna, 44124
IRCCS Azienda Ospedaliera Universitaria San Martino
Genoa, Liguria, 16132
Az.Osp. Univ. Policlinico di Modena
Modena, Emilia-Romagna, 41124
IRCCS Fondazione Pascale
Naples, Campania, 80131
Az. Osp. Univ. di Parma
Parma, Emilia-Romagna, 43126
Az. Osp. Univ. Città Della Salute e Della Scienza di Torino
Turin, Piedmont, 10126
About this study
Official title: A Multicentre, Double Blind, Randomized Placebo Controlled Trial to Assess the Effect of LF-PB on Seroma Formation in Women With Breast Cancer Undergoing Axillary Lymph Node Dissection
This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND).
Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.
Read the detailed description
The study will randomize between 24 and 72 subjects that received an ALND. A staged adaptive design is employed with two intermediate analyses and a final analysis. The first interim analysis at 24 treated subjects (at least 12 in each group) and the second at 48 treated subjects (at least 24 in each group).
- Conditions
- Seroma
- Being tested
- extended release of octreotide, extended release of placebo
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended release of octreotideDrug
Also called LF-PB 30 mg
1 intramuscular injection of extended release of octreotide 30 mg
extended release of placeboDrug
Also called Placebo
1 intramuscular injection of extended release of placebo
| Study group | Role | What they receive |
|---|---|---|
| LF-PB 30 mg | Experimental | extended release of octreotide Receives: Drug: extended release of octreotide |
| Placebo | Placebo comparator | extended release of placebo Receives: Drug: extended release of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of seromas requiring an aspiration
Subjects will undergo an echography at the operated axilla at every scheduled visit till Day 28 or until seroma resolution, whichever occurs first. In case of seroma presence the investigator will decide if an aspiration is required; the decision will be based on the clinical investigator's evaluation.
In case of aspiration, the subject with seroma will be considered amenable for the statistical analysis of seroma incidence.
Measured: Day 28 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start22 Oct 2015
- Primary completion19 Jul 2016
- Study completion19 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeromaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemi S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Carcoforo, Prof., Principal investigator, U.O. Clinica Chirurgica, A. O. Univ. Arcispedale S.Anna - Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668588
- Sponsor's protocol ID
- LF-PB/14/05
- Status last verified
- Feb 2017
- First submitted
- 27 Jan 2016
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double Blind, Randomized Placebo Controlled Trial to Assess the Effect of LF-PB on Seroma Formation in Women With Breast Cancer Undergoing Axillary Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT02668588
- Acronym / sponsor ID
- LF-PB/14/05
- Conditions
- Seroma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chemi S.p.A.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 19 Jul 2016 (actual)
- Study completion
- 19 Jul 2016 (actual)
- First posted
- 29 Jan 2016 (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 is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND).
Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.
Detailed description
The study will randomize between 24 and 72 subjects that received an ALND. A staged adaptive design is employed with two intermediate analyses and a final analysis. The first interim analysis at 24 treated subjects (at least 12 in each group) and the second at 48 treated subjects (at least 24 in each group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LF-PB 30 mg | Experimental | Drug: extended release of octreotideextended release of octreotide |
| Placebo | Placebo comparator | Drug: extended release of placeboextended release of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form;
- Undergoing breast cancer surgery with axillary lymph node dissection during the current clinical trial;
- Negative serum pregnancy test for women of childbearing potential;
- Aspartate aminotransferase and alanine aminotransferase < 2 x the upper limit of normal;
- ECOG PS ≤ 1.
Key exclusion criteria (14 listed)
- Previous axillary surgery on the same armpit (sentinel lymph node surgery is not exclusionary);
- Previous radiotherapy within five years from study drug administration on the same armpit undergoing surgery in this study;
- Concomitant participation to other clinical trial;
- Uncontrolled diabetes;
- Cholelithiasis;
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 |
|---|---|---|
| extended release of octreotideAlso: LF-PB 30 mg1 intramuscular injection of extended release of octreotide 30 mg | Drug | LF-PB 30 mg |
| extended release of placeboAlso: Placebo1 intramuscular injection of extended release of placebo | Drug | Placebo |
Primary outcome
Incidence of seromas requiring an aspiration
Time frame: Day 28 post surgery
Subjects will undergo an echography at the operated axilla at every scheduled visit till Day 28 or until seroma resolution, whichever occurs first. In case of seroma presence the investigator will decide if an aspiration is required; the decision will be based on the clinical investigator's evaluation. In case of aspiration, the subject with seroma will be considered amenable for the statistical analysis of seroma incidence.
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 2 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Paolo Carcoforo, Prof. principal investigator
U.O. Clinica Chirurgica, A. O. Univ. Arcispedale S.Anna - Ferrara
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing extended release of octreotide in people with Seroma, run by Chemi S.p.A. at 7 sites in Italy.
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 5 inclusion and 14 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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?
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?
Incidence of seromas requiring an aspiration (time frame: Day 28 post surgery). 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 2 Feb 2017.