LymphorrheaPhase 2NCT01754285
Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea
A Phase 2 study testing LF-PB in people with Lymphorrhea, run by Chemi S.p.A. at 13 sites in Italy.
Trial summary
This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Lymphorrhea
- What is being tested?
- LF-PB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 13 sitesItaly
- Study dates
- Nov 2012to May 2014
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged 18 to 80 years inclusive
- Body mass index (BMI) ≥18 kg/m2
- Signed informed consent form
- Diagnosis of BC
- Undergoing breast surgery with ALND Note: Collagen powder or fibrin sealant are not permitted.
- Negative serum pregnancy test for women of childbearing potential Note: Female patients of child-bearing potential should be advised to use adequate contraception if necessary during treatment with octreotide.
- AST and alanine aminotransferase ALT <1.5 x the upper limit of normal
- Ability to fully understand all study procedures and to comply with study visits scheduled for the duration of the study.
Who cannot join
- Presence of any of the following conditions:
- Previous axillary surgery on the same armpit undergoing surgery in this study
- Previous chemotherapy or radiotherapy within five years from study drug administration
- Previous neoadjuvant therapy
- Recurrent BC on the same breast undergoing surgery in this study
- Diabetes
Show all 18Show fewer
- Cholelithiasis
- Hypothyroidism. If patient is being administered Euritox/ 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.
- Hepatitis
- Pregnant or lactating
- Human immunodeficiency virus or hepatitis B or C by screening serology
- History of radiotherapy on the same breast or armpit undergoing surgery in this study.
- History of anaphylaxis to study drug
- Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation
- QTc interval extension 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 (see Appendix 2 for a list of such compounds)
- Clinically significant or relevant abnormal medical history, vital sign, physical examination, ECG, or laboratory evaluation finding
- Current or recurrent disease that could affect the results of the clinical or laboratory assessments required for the study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Azienda Ospedaliera OIRM Sant'Anna Dipartimento Funzionale di Oncologia - Breast Unit
Corso Spezia, 60 Torino, 10126
IRCCS Azienda Ospedaliero Universitaria San Martino di Genova - IST Genova Dipartimento Chirurgia Ospedaliera - Semeiotica Chirurgica e Chirurgia Senologica
L.go Rosanna Benzi,10 Genova, 16132
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Chirurgia Generale Universitaria "G.Marinaccio"
Piazza Giulio Cesare 11 Bari, 70124
Azienda Ospedaliero-Universitaria Di Pisa
Pisa, 56123
Universita' Campus Bio-medico di Roma
Roma, 00128
Ospedale Casa Sollievo della Sofferenza - Istituto di Ricovero e Cura a Carattere Scientifico Opera di San Pio da Pietrelcina
San Giovanni Rotondo, 71013
Fondazione del Piemonte per l'Oncologia - IRCC Candiolo D.O. di Ginecologia Oncologica
Strada Provinciale 142 Km 3.95- Candiolo, 10060
Azienda Ospedaliero-Universitaria di Parma Dipartimento Clinica Chirurgica e Terapia Chirurgica
Via Gramsci, 14 Parma, 43126
IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione Giovanni Pascale Dipartimento di Senologia - Struttura Complessa Oncologia Medica Senologica
Via Mariano Semmola Napoli, 80131
Azienda Ospedaliero Universitaria Policlinico di Modena Unità Semplice di Senologia
Via Pozzo 71, Modena, 41124
Humanitas Centro Catanese di Oncologia Dipartimento di Oncologia -Chirurgia Oncologica Generale
Via V.E. Dabormida, 64, Catania, 95125
Azienda Ospedaliero Universitaria di Ferrara c/o Ospedale di Cona Sezione di Clinica Chirurgica
Vial Aldo Moro 8, Cona-Ferrara, 44124
Fondazione per la Ricerca e la Cura dei Tumori "Tommaso Campanella" Unità Operativa Complessa CRR per il Counselling Genetico e le Terapie Innovative in Oncologia Medica
Viale Europa-Loc. Germaneto, Catanzaro, 88100
About this study
Official title: A Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of LF-PB 10 mg, 20 mg, and 30 mg to Treat Lymphorrhea Post Axillary Dissection in Breast Cancer
This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection.
Recruited patients will be randomly assigned to one of the following treatment groups: Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.
Read more
Mode of administration is single intramuscular (IM) injection so the treatments arms are as follows:
Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2 injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg
The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.
- Conditions
- Lymphorrhea
- Being tested
- LF-PB and Placebo, Placebo, LF-PB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LF-PB and PlaceboDrug
Also called extended-release of octreotide and placebo
PlaceboDrug
LF-PBDrug
Also called LF-PB 10 mg and LF-PB 20 mg
| Study group | Role | What they receive |
|---|---|---|
| LF-PB 10 mg | Experimental | 2 IM injections = placebo + 10 mg Receives: Drug: LF-PB and Placebo |
| LF-PB 20 mg | Experimental | 2 IM injections = placebo + 20 mg Receives: Drug: LF-PB and Placebo |
| LF-PB 30 mg | Experimental | 2 IM injections = 10 mg + 20 mg Receives: Drug: LF-PB |
| Placebo | Placebo comparator | 2 IM injections of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea;
End of lymphorrhea will be declared when the lymph volume measured by the patient is < 50 ml/day in 2 consecutive days.
Measured: 12 weeks post surgery
number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB 10 mg, 20 mg, and 30 mg
Safety and tolerability of LF-PB
Measured: 12 weeks after surgery
Secondary outcomes (3)
effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain
daily volume of lymph collected from the drain
Measured: 12 weeks after surgery
number of complications related to lymphorrhea
effect of LF-PB 10, 20 and 30 mg on complications related to lymphorrhea
Measured: 12 weeks after surgery
PK profile (Cmax, Tmax, AUC0-t and possibly AUC0-inf and T1/2) of LF-PB 10, 20 and 30 mg
PK parameters
Measured: 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphorrheaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemi S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Carcoforo, MD, Principal investigator, Clinica Chirurgica, Azienda Ospedaliero-Universitaria Arcispedale "S. Anna" Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754285
- Sponsor's protocol ID
- LF-PB/11/04
- Status last verified
- Jul 2014
- First submitted
- 12 Dec 2012
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of LF-PB 10 mg, 20 mg, and 30 mg to Treat Lymphorrhea Post Axillary Dissection in Breast Cancer
- ClinicalTrials.gov ID
- NCT01754285
- Acronym / sponsor ID
- LF-PB/11/04
- Conditions
- Lymphorrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Chemi S.p.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Dec 2012 (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 phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection.
Recruited patients will be randomly assigned to one of the following treatment groups: Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.
Mode of administration is single intramuscular (IM) injection so the treatments arms are as follows:
Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2 injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg
The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LF-PB 10 mg | Experimental | Drug: LF-PB and Placebo2 IM injections = placebo + 10 mg |
| LF-PB 20 mg | Experimental | Drug: LF-PB and Placebo2 IM injections = placebo + 20 mg |
| LF-PB 30 mg | Experimental | Drug: LF-PB2 IM injections = 10 mg + 20 mg |
| Placebo | Placebo comparator | Drug: Placebo2 IM injections of placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female aged 18 to 80 years inclusive
- Body mass index (BMI) ≥18 kg/m2
- Signed informed consent form
- Diagnosis of BC
- Undergoing breast surgery with ALND Note: Collagen powder or fibrin sealant are not permitted.
Key exclusion criteria (18 listed)
- Presence of any of the following conditions:
- History of radiotherapy on the same breast or armpit undergoing surgery in this study.
- History of anaphylaxis to study drug
- Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation
- QTc interval extension at screening or baseline > 450 msec (as the mean of 3 consecutive readings 5 minutes apart)
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 |
|---|---|---|
| LF-PB and PlaceboAlso: extended-release of octreotide and placebo | Drug | LF-PB 10 mg, LF-PB 20 mg |
| Placebo | Drug | Placebo |
| LF-PBAlso: LF-PB 10 mg and LF-PB 20 mg | Drug | LF-PB 30 mg |
Primary outcome
effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea;
Time frame: 12 weeks post surgery
End of lymphorrhea will be declared when the lymph volume measured by the patient is < 50 ml/day in 2 consecutive days.
number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB 10 mg, 20 mg, and 30 mg
Time frame: 12 weeks after surgery
Safety and tolerability of LF-PB
3 secondary outcomes
effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain
Time frame: 12 weeks after surgery
number of complications related to lymphorrhea
Time frame: 12 weeks after surgery
PK profile (Cmax, Tmax, AUC0-t and possibly AUC0-inf and T1/2) of LF-PB 10, 20 and 30 mg
Time frame: 12 weeks after surgery
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 29 Jul 2014.
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, MD principal investigator
Clinica Chirurgica, Azienda Ospedaliero-Universitaria Arcispedale "S. Anna" Ferrara
13 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 LF-PB in people with Lymphorrhea, run by Chemi S.p.A. at 13 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 8 inclusion and 18 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 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea; (time frame: 12 weeks post surgery). The study lists 2 primary outcomes in all. 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 29 Jul 2014.