Perioperative Treatment With Tranexamic Acid in Melanoma
About this study
Surgery is a key element in the treatment of melanoma, and naturally linked with an inflammatory response and recruitment of innate immune cells. Although surgery has a favorable intent, surgery-induced inflammation, neutrophils in particular, may accelerate growth of local and systemic micrometastases. Thus, improving cancer surgery and modulating the wound microenvironment in ways that benefit the patients is crucial. Repurposing already approved drugs in a cancer setting has gained increasing interest in recent years. Interestingly, tranexamic acid was recently suggested as an anti-cancer drug, capable of reducing tumor growth in experimental animal models and reducing the viability of different melanoma cell lines. As a novel approach, sponsor and investigators will conduct a Randomised Clinical Trial, using perioperative treatment with Tranexamic Acid, aiming to prevent the early relapses for patients with melanoma.
- Condition
- Melanoma
- Tested
- Tranexamic acid, Saline
- Sponsor
- University of Aarhus
Who can join
- Age
- 18 to 80 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Maximum age: 80 years
- Study condition: Melanoma
- Patients
- Diagnosed with invasive cutaneous melanoma (pathological stage/tumor grade ≥T2b), defined as either: Breslow thickness \>1.0-2.0 mm with presence of ulceration or Breslow thickness \>2.0 mm regardless of ulceration status.
- Eligible for surgery (wide local excision and sentinel lymph node biopsy).
- \>/=18 years of age and \</=80 years of age
- Signed Informed Consent Form
Exclusion 9
- Patients
- With a prior history of invasive melanoma
- Thromboembolic events within the last 3 months
- Pregnancy
- Active breastfeeding
- Known allergy or hypersensitivity to TXA
- Known and treated epilepsia or previous seizures
- eGFR 0-50
- Current use of tranexamic acid
Where
5 sites, 3 recruiting
Aalborg University Hospital. Dept. of Plastic- and Breast Surgery.
Aalborg, North Denmark, Denmark
Aarhus University Hospital. Dept. of Plastic- and Breast Surgery
Aarhus, Central Jutland, Denmark
Copgenhagen University Hospital, Rigshospitalet. Dept. of Plastic Surgery and Burns Treatment
Copenhagen, Denmark
Copenhagen University Hospital, Herlev. Dept. of Plastic Surgery
Herlev, Denmark
Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic Surgery
Vejle, Denmark
Contact
-
Marie Louise Bønnelykke-Behrndtz, MD, PhD
+45 78 45 00 00 marboe@rm.dk
-
Karoline Kristjansen, MD
Potential match only. Final eligibility is determined by the study team.