Extended-release of Octreotide (LF-PB) for the Treatment of Seroma (NCT02668588) | Clinical Trial Compass
CompletedPhase 2
Extended-release of Octreotide (LF-PB) for the Treatment of Seroma
Italy48 participantsStarted 2015-10-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* 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 fi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.