RecruitingPhase 2NCT05284552

Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer

The Effect of Tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy - A Randomized Pilot Study

Sponsor

University Hospital, Linkoeping

Enrollment

40 participants

Start Date

Jul 12, 2022

Study Type

INTERVENTIONAL

Conditions

Epithelial Ovarian Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether adding the blood thinner tinzaparin (a type of heparin) to standard chemotherapy (called neoadjuvant chemotherapy, given before surgery) improves outcomes for women with advanced ovarian cancer. It also collects blood samples to study biomarkers that might predict treatment response. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with high-grade ovarian, fallopian tube, or peritoneal cancer (FIGO stage III or IV) - You are being treated with platinum-based chemotherapy before surgery at a participating hospital in Sweden - Your CA-125 blood level is at least 250 at diagnosis **You may NOT be eligible if...** - You are currently taking blood thinners (heparins, warfarin, or similar drugs), or have used them in the past year - You have had a blood clot in the past year or are currently being treated for one - You have had major surgery in the past year - You are pregnant or breastfeeding - You have known brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTinzaparin Injectable Solution

Subcutaneous injection

Locations(8)

Department of Obstetrics and Gynecology, Highland Hospital

Eksjö, Eksjö, Sweden

Department of Oncology, Sahlgrenska University Hospital

Gothenburg, Gothenburg, Sweden

Department of Obstetrics and Gynecology, Ryhov County Hospital

Jönköping, Jönköping County, Sweden

Department of Oncology, Linköping University Hospital

Linköping, Linköping, Sweden

Department of Obstetrics and Gynaecology, Norrland University Hospital

Umeå, Umeå, Sweden

Department of Obstetrics and Gynecology, Värnamo Hospital

Värnamo, Värnamo, Sweden

Department of Obstetrics and Gynecology, Västervik Hospital

Västervik, Västervik, Sweden

Department of Obstetrics and Gynecology, University Hospital

Linköping, Östergötland County, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05284552

Related Trials

Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells

NCT063052991 location

A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)

NCT054299707 locations

A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

NCT0689033861 locations

Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer

NCT075895431 location

Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

NCT063868871 location