Radiation to Treat Joint Damage Caused by Cancer Immunotherapy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Chicago
About this trial
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which they are receiving single agent or combination immunotherapy or within the last 6 months.
Rheumatologist-established diagnosis of new onset CTCAE grade 2-3 immunotherapy-induced inflammatory arthritis or activated osteoarthritis, involving one or more joints (up to 3) including but not limited to hands, shoulders, elbows, hips, knees and ankles.
Age ≥ 40 years.
ECOG performance status ≤2 (Karnofsky ≥60%).
Disqualifiers
Contraindications to radiation treatment, such as pregnancy, breast-feeding women and active collagen-vascular disease.
Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was >1 year prior to consent and/or clear documentation states that the patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to initiation of study treatment.
Have not received systemic steroids within the last 3 months for the treatment of immune related adverse events.
History of prior autoimmune conditions, or concurrent immune related adverse events requiring systemic immunosuppressants.
Trial design
Design model
Single group
Treatments tested in this trial
Low dose radiation therapy
Radiation0.5 Gy per treatment x 6 treatments, given 2-3 treatments per week over 2-3 weeks (Can be given concurrently with IO)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Radiation treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Radiation therapy
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.Secondary outcomes
1
Effectiveness of Radiation in treating immunotherapy-induced arthritis.
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.2
To examine the use of steroids.
Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain.
Time frame
3 months post enrollment.3
To examine the use of rescue analgesics.
Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain.
Time frame
3 months post enrollment.4
Effectiveness of Radiation in treating immunotherapy-induced arthritis.
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.Sponsors and contacts
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Source ClinicalTrials.gov
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