The University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
NCT Number: NCT07478679
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
Trial opening soon.
Get Notified40 year and older
All sexes
Interventional
Phase 1
Chicago, Illinois, 60637, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5 Gy per treatment x 6 treatments, given 2-3 treatments per week over 2-3 weeks (Can be given concurrently with IO)
Time frame: 3 months post enrollment.
To assess the safety and feasibility of administering Low dose radiation therapy (LDRT) in patients with immunotherapy-induced arthritis. Number of patients that experience at least one treatment related Common Terminology Criteria for Adverse Events (CTCAE) grade 4 or 5 side effect.
Time frame: 3 months post enrollment.
To assess pain relief in patients using the Common Terminology Criteria for Adverse Events (CTCAE) v5 pain assessment. Grade 1 represents mild pain or mild pain with inflammation, erythema, or joint swelling. Grade 2 represents moderate pain/moderate pain with signs of inflammation, erythema, or joint swelling, limiting instrumental activities of daily living (ADLs). Grade 3 represents severe pain/severe pain with signs of inflammation, erythema, or joint swelling, irreversible joint damage, limiting instrumental activities of daily living (ADLs).
Time frame: 3 months post enrollment.
Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain.
Time frame: 3 months post enrollment.
Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain.
Time frame: 3 months post enrollment.
To assess pain relief in patients using the Visual Analogue Pain Scale (VAPS) score. The scale is bordered by "no pain" (score of 0) and "worst imaginable pain" (score of 10)
Time frame: 3 months post enrollment.
To assess pain relief in patients using the Von Pannewitz Score (VPS). The responses are rated as follows: stable (no improvement), slightly improved, markedly improved, and painless.
Contact information is provided by the study sponsor or research team.
University of Chicago
Other
Use of Low-Dose RADiotherapy in the Management of Immune Checkpoint- Inhibitor-ArThropathy as an Immune-Related Adverse Event (RADIATE)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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