Perioperative Treatment With Tranexamic Acid in Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic acid, Saline.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Perioperative Treatment With Tranexamic Acid in Melanoma; Prognostic and Treatment-related Impact of the Plasminogen-plasmin Pathway
Overview
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.
Detailed description
The objective of the proposed clinical trial is to test if perioperative treatment with tranexamic acid (TXA) reduces the early relapses and postoperative complications for patients with melanoma and evaluate perioperative inflammation and the prognostic- and treatment-related impact of the plasminogen-plasmin pathway from human blood- and tissue samples.
Primary aim:
To test if perioperative treatment with TXA is superior to placebo and reduces the early relapse rates, from 37% to 26%, for patients diagnosed with melanoma undergoing sentinel lymph node biopsy surgery.
Secondary aims:
1. Evaluate safety and tolerability: defined as mild (abdominal pain, diarrhea, or nausea) or severe (thromboembolic events) adverse effects. 2. Evaluate postoperative complications: defined as bleeding, seroma formation, and infections within the first three postoperative months. 3. Estimate melanoma-specific survival probabilities and compare the two treatment groups.
Explorative:
From blood- and tissue samples, baseline and perioperative changes of factors associated with inflammation, fibrinolysis, metabolism, immune cell composition, and activation status will be monitored and factors will be associated with prognostic and treatment-related outcomes.
Interventions
- Drug Tranexamic acid
A single preoperative intravenous dose and per os treatment postoperatively day 1 through 4 - Drug Saline
A single preoperative intravenous dose and per os treatment postoperatively day 1 through 4
Primary outcome measures
- Difference in rate of relapse within two years when comparing treatment arms [Time frame: 2 year follow-up]
Secondary outcome measures (5)
- Incidence of treatment-related adverse events [Time frame: 6 months follow-up]
- Assessment of incidens of postoperative complications [Time frame: 3 months follow-up]
- Melanoma-specific survival [Time frame: 2 year follow-up]
- Overall survival [Time frame: 2 year follow-up]
- Relapse free survival [Time frame: 2 year follow-up]
Eligibility 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 </=80 years of age
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Denmark · 5 centers
- Aarhus University Hospital. Dept. of Plastic- and Breast Surgery — Aarhus
- Aalborg University Hospital. Dept. of Plastic- and Breast Surgery. — Aalborg
- Copgenhagen University Hospital, Rigshospitalet. Dept. of Plastic Surgery and Burns Treatm — Copenhagen
- Copenhagen University Hospital, Herlev. Dept. of Plastic Surgery — Herlev
- Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic Surgery — Vejle
Publications
- Kristjansen KA, Engel Krag A, Schmidt H, Holmich LR, Bonnelykke-Behrndtz ML. Perioperative treatment with tranexamic acid in melanoma (PRIME): protocol for a Danish multicentre randomised controlled trial investigating the prognostic and treatment-related impact of the plasminogen-plasmin pathway. BMJ Open. 2024 Feb 2;14(2):e077012. doi: 10.1136/bmjopen-2023-077012. PMID 38309757
Identifiers
NCT: NCT05899465 · PRIME