Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer
ConditionEpithelial Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Linkoeping
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed.
Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year.
Known or suspected allergies against any product included in the study
Ongoing pregnancy, independent of gestational age. Breastfeeding or planned pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Tinzaparin Injectable Solution
DrugSubcutaneous injection
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Changes in serum levels of CA-125
kIU/L
Time frame
14 weeksSecondary outcomes
1
Changes in serum levels of CA-125
kIU/L
Time frame
21-28 weeks2
Changes in blood levels of hemoglobin
g/L
Time frame
21-28 weeks3
Changes in blood levels of platelets
x10\^9/L
Time frame
21-28 weeks4
Changes in blood levels of leucocytes
x10\^9/L
Time frame
21-28 weeksOther outcomes
1
Plasma levels of tissue factor
µg/L
Time frame
21-28 weeks2
Plasma levels of D-dimer
mg/L
Time frame
21-28 weeks3
Plasma levels of soluble P-selectin
µg/L
Time frame
21-28 weeks4
Plasma levels of thrombin-antithrombin complex
µg/L
Time frame
21-28 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Linkoeping
Lead sponsor
Region Jönköping County
Collaborator
Västervik Hospital
Collaborator
Vastra Gotaland Region
Collaborator
Region Västerbotten
Collaborator
Source ClinicalTrials.gov