Melanoma Clinical Trials

Find Melanoma Clinical Trials Near You

Perioperative Treatment With Tranexamic Acid in Melanoma; Prognostic and Treatment-related Impact of the Plasminogen-plasmin Pathway

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Denmark
Aalborg University Hospital. Dept. of Plastic- and Breast Surgery.
RECRUITING
Aalborg
Aarhus University Hospital. Dept. of Plastic- and Breast Surgery
RECRUITING
Aarhus
Copgenhagen University Hospital, Rigshospitalet. Dept. of Plastic Surgery and Burns Treatment
RECRUITING
Copenhagen
Copenhagen University Hospital, Herlev. Dept. of Plastic Surgery
ACTIVE_NOT_RECRUITING
Herlev
Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic Surgery
ACTIVE_NOT_RECRUITING
Vejle
Contact Information
Primary
Marie Louise Bønnelykke-Behrndtz, MD, PhD
marboe@rm.dk
+45 78 45 00 00
Backup
Karoline Kristjansen, MD
karoline_kristjansen@clin.au.dk
Time Frame
Start Date: 2023-08-25
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 1204
Treatments
Experimental: Tranexamic Acid
A single dose of TXA (15 mg/kg) administered intravenously 30 min (+/-15 min) before skin incision and subsequently, TXA (1000 mg) administered orally 4 and 8 hours post-surgery and TXA (1000 mg) 3 times daily through postoperative day 4.
Placebo_comparator: Placebo
A single dose of saline matching the volume of the experimental arm treatment regiment (Saline) administered intravenously 30 min (+/-15 min) before skin incision and subsequently, placebo tablets (2 tabs.) administered orally 4 and 8 hours post-surgery and (2 tabs) 3 times daily through postoperative day 4.
Related Therapeutic Areas
Sponsors
Collaborators: Central Denmark Region, Aarhus University Hospital
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov

Similar Clinical Trials