Perioperative Treatment With Tranexamic Acid in Melanoma

• Status: Not yet recruiting
• Trial end date: 2029-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Central Denmark Region
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

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
• Signed Informed Consent Form

Exclusion Criteria:

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