Tests tinzaparin with chemotherapy in women with ovarian cancer
Tests whether tinzaparin affects markers in adults with ovarian cancer receiving chemotherapy first.
Plain-language title generated from the registry record
Registry title: Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer
Key facts
- Where
- Eksjo, Goteborg, Jonkoping, Linkoping, Umea, Varnamo, and Vastervik, SwedenSee the 7 sites
- Phase
- Phase 2
Where in Sweden
- Region Joenkoepings LaenEksjo, SwedenTaking people
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborg, SwedenTaking people
- Region Joenkoepings LaenJonkoping, SwedenTaking people
- Region OestergoetlandLinkoping, SwedenTaking people
- Region VaesterbottenUmea, SwedenTaking people
- Region Joenkoepings LaenVarnamo, SwedenTaking people
- Vaesterviks Sjukhus Region Kalmar LaenVastervik, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Linkoeping
- Trial code
- NCT05284552EU 2024-515450-24-00
- Record updated
- 11 May 2026
- Original description
Background:Read full original descriptionShow less
The Effect of Tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy - A Randomized Pilot Study
Background:
Previous findings have indicated antineoplastic properties of tinzaparin (Innohep®), a commonly used anti-coagulant. Earlier studies have mainly investigated the antineoplastic effects of tinzaparin in animal models and in human cell-lines. In this pilot study the aim is to examine the potential antitumoral effects of tinzaparin in vivo in women with epithelial ovarian cancer (EOC).
Study objectives:
Primary objective: The primary objective of the study is to evaluate the effects of tinzaparin on changes in levels of CA-125 in EOC patients who receive neoadjuvant chemotherapy (NACT).
Secondary objectives: The secondary objective of the study is to explore the impact of tinzaparin on the dynamic of a spectrum of immunological and coagulation factors in EOC patients who receive NACT. Besides, the compliance of tinzaparin injections and adverse events caused by tinzaparin will be described.
Inclusion: The subject has given written consent to participate in the study; Age 18 and above; Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy indicates an origin from the ovary, fallopian tube or peritoneum; Histology diagnosis of either high grade serous carcinoma, endometroid carcinoma or clear cell carcinoma; FIGO stage III-IV disease; Planned for platinum-based chemotherapy; Prior to start of NACT pregnancy should be ruled out by menstrual history or in unclear cases by a urine hCG test; Women of childbearing potential should use a safe birth control method (combined hormonal contraception, progesterone only hormonal contraception, intra uterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence, male or female condom, diaphragm with spermicide); WHO Performance Status 0-2; Weight 50-150 kg; CA-125-level ≥250 kIE/L at diagnosis.
Exclusion: Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year; Abdominal surgery or other major surgery within the last year; Participation or recent participation (within the last 30 days) in a clinical study with an investigational product; Previous heparin-induced thrombocytopenia; Known or suspected allergies against any product included in the study; Treatment or disease which, according to the investigator, can affect treatment or study results; Ongoing treatment of thromboembolic disease; Thromboembolic disease within the last year; Hypersensitivity to the active substance (tinzaparin) or any of the excipients; Severe coagulation disorder; Acute gastro duodenal ulcer; Treatment for other known malignancy within the last year (except basal cell carcinoma); Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed; Serious hemorrhage or conditions predisposing to serious hemorrhage. Serious hemorrhage is defined as fulfilling any one of these three criteria:; occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome),; causes a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or; leads to transfusion of two or more units of whole blood or red blood cells; E-GFR <30ml/min (analyzed no more than 14 days before start of treatment with investigational product); Platelets <100 x10\^9/L (analyzed no more than 14 days before start of treatment with investigational product); Ongoing pregnancy, independent of gestational age. Breastfeeding or planned pregnancy; EOC disclosed at Cesarean section; Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation; Known brain metastasis; Septic endocarditis; WHO Performance Status >2.