Arthritis, Arthropathy
Conditions
Keywords
Radiotherapy, Arthropathy, Immunotherapy, Cancet
Brief summary
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
Interventions
RADIATIONLow dose radiation therapy
0.5 Gy per treatment x 6 treatments, given 2-3 treatments per week over 2-3 weeks (Can be given concurrently with IO)
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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%). * Patients with ability and willingness to sign consent.
Exclusion criteria
* 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. * Estimated life expectancy less than 3 months as assessed by investigators. * Any condition at the discretion of investigator that will preclude participation in the study. * History of secondary malignancy as assessed by investigators. * History of radiation to affected joints as assessed by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Radiation in treating immunotherapy-induced arthritis. | 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). |
| To examine the use of steroids. | 3 months post enrollment. | Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain. |
| To examine the use of rescue analgesics. | 3 months post enrollment. | Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain. |
Countries
United States
Contacts
CONTACTClinical Trials Intake
PRINCIPAL_INVESTIGATORPankti Reid
University of Chicago
Outcome results
None listed