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Trial Title:
Perioperative Treatment With Tranexamic Acid in Melanoma
NCT ID:
NCT05899465
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Tranexamic Acid
Conditions: Keywords:
Melanoma
Tranexamic acid
Relapse
Cancer
Drug Repositioning
Surgery
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel, two-arm, randomized, blinded Danish multi-center trial
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Participants, care providers, investigators/outcome assessors are all blinded to the
intervention. Selected trained personnel who does not treat or assess the participants
will be unblinded to prepare the intervention for administration and deliver the
intervention to blinded personnel for administration.
Intervention:
Intervention type:
Drug
Intervention name:
Tranexamic acid
Description:
A single preoperative intravenous dose and per os treatment postoperatively day 1 through
4
Arm group label:
Tranexamic Acid
Intervention type:
Drug
Intervention name:
Saline
Description:
A single preoperative intravenous dose and per os treatment postoperatively day 1 through
4
Arm group label:
Placebo
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.
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Louise Bønnelykke-Behrndtz, MD, PhD
Facility:
Name:
Aalborg University Hospital
Address:
City:
Aalborg
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Karoline Kristjansen, MD
Start date:
August 25, 2023
Completion date:
September 1, 2028
Lead sponsor:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Central Denmark Region
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05899465
