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NCT03946007
Quality of Life and Physical Fitness After Immune Checkpoint Inhibitors
trial in Melanoma in 134 participants. Completed in 1 May 2022.
1 May 2022
Quick facts
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 134 |
| Start date | 4 October 2018 |
| Primary completion | 1 May 2022 |
| Estimated completion | 1 May 2022 |
| Sites | 1 location across Netherlands |
Conditions studied
- Melanoma — all drugs for Melanoma →
- Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
Sponsor
University Medical Center Groningen
Who can join
18 and older, any sex, with Melanoma or Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rationale: Tremendous anti-tumor effects have been achieved using immune checkpoint inhibitors for melanoma and NSCLC with long lasting responses of more than 2 years in a substantial subgroup of patients. However, we are still largely unaware of the health-related quality of life of these patients. We should carefully and thoroughly assess the long-term burden of disease and treatment toxicity. Objective: Primary Objective: to investigate health-related quality of life (HRQoL) of patients surviving 2 years or more after the first cycle of an immune checkpoint inhibitor for melanoma or NSCLC. Secondary Objectives: to assess neurocognitive function, endocrine function, cardiovascular risk, physical fitness, mood disorders, sexual problems, work participation in patients surviving 2 years or more after the first cycle of immune checkpoint inhibitor; to assess quality of life of the caregivers of these patients. Study design: Observational cross-sectional study. Study population: Patients (age ≥18 years) with melanoma or NSCLC ≥2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both). Main study parameters/endpoints: health-related quality of life (HRQoL) as measured using the EORTC Quality of life questionnaire (QLQ-C30). Secondary study parameters: possible late effects (neurocognitive dysfunction, endocrine disorders, dermatologic complaints, sexual disorders and infertility, increased cardiovascular risk, and fatigue), physical fitness, psychosocial issues related to work/education, mood disorders (anxiety and depression), patient and treatment-related factors potentially influencing development of late effects, well-being, and quality of life of caregivers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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The potential role of exercise in mitigating fertility toxicity associated with immune checkpoint inhibitors (ICIs) in cancer patients.
Jamrasi P, Tazi M, Zulkifli NA, Bae JH, et al · · 2024 · cited 1× · PMID 39616333 · DOI 10.1186/s12576-024-00950-3
Verify or expand the search:
- PubMed search for NCT03946007
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03946007 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Center Groningen
- Last refreshed: 6 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03946007.
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