Chronic stress and Responsiveness to Immunotherapy for Metastasized Melanoma

Recruiting

• Conditions: malignant melanoma; skin cancer; 10040900

• Registration Number: NL-OMON55104
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Adults (above 18 years)
Diagnosed with metastasized melanoma
Starting immunotherapy within the next two weeks.
Treatment regimen: pembrolizumab 3 or 6-weekly, nivolumab 4-weekly,
ipilimumab/nivolumab 3-weekly.

Exclusion Criteria

Age under 18 years
Obvious intellectual impairment
Insufficient knowledge of the Dutch language.
Patients with no or very short hair

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter is whether chronic stress is related to response 3 and 6<br /><br>months after the start of immunotherapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Demographic (age, gender, social relational variables) and medical variables<br /><br>(type, duration and doses of immunotherapy, immunotherapy related adverse<br /><br>events, use of immunosuppressive agents, LDH, pain, WHO-performance, location<br /><br>of metastases, oral contraceptive use) will be collected from medical records<br /><br>and by asking some additional questions at baseline. </p><br>