Many people develop joint pain, stiffness and swelling due to their cancer treatment that targets the immune system. The severity of symptoms ranges from mild to debilitating and sometimes requires delaying or stopping cancer treatment. The usual plan is to discontinue cancer treatment and give relatively high doses of a medication called prednisone (a steroid, which is an anti-inflammatory medication which may suppress the immune system) with a gradual lowering of the dose over several weeks. While this can be effective, prednisone can cause a number of side effects, and it is not known if this is the best or safest treatment. Hydroxychloroquine is a medication that is often used to treat inflammatory joint pain, such as rheumatoid arthritis, has relatively few side effects when compared to prednisone, and may be effective at treating this condition. The purpose of this study is to find out whether it is better to receive hydroxychloroquine and prednisone, or prednisone alone for joint pain. To do this, some participants will get hydroxychloroquine and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable. This is a double-blinded study, which means that neither participants nor the study doctor or study staff will know which group participants are allocated. After 12 weeks of study treatment, the blind will be opened and participants will be informed which treatment was given.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
Hydroxychloroquine 5mg/kg PO daily
Hydroxychloroquine-matching placebo
Cross Cancer Institute
Edmonton, Alberta, Canada
RECRUITINGRecurrence of grade ≥2 Immune-Related Arthritis or Arthralgia
Recurrence will be defined as the development of grade ≥2 irAA in a participant whose symptoms initially improved to grade ≤1. Symptoms will be investigator assessed and graded according to CTCAEv5.0.
Time frame: Through study completion, an average of 1 year
Total Steroid Usage
The total cumulative dose of prednisone measured in mg used by the participant. If corticosteroids other than prednisone are used, their equivalent dosage in mg of prednisone will be calculated and used for this analysis.
Time frame: Through study completion, an average of 1 year
Development of immune related adverse events (irAE's) other than irAA
Defined as the emergence of adverse events that were not present at study baseline that are deemed by the investigator to be related to prior use of immune checkpoint inhibitors. Causality will be investigator assessed and graded according to CTCAEv5.0.
Time frame: Through study completion, an average of 1 year
Adverse Event
The emergence of new or worsening baseline symptoms, physical findings, or laboratory/imaging abnormalities. Causality to study treatment, immune checkpoint inhibitors, or underlying disease status will be investigator assessed and graded according to CTCAEv5.0.
Time frame: Through study completion, an average of 1 year
Re-initiation of immune checkpoint inhibitor therapy
The proportion of participants in each study arm that are re-treated with an immune checkpoint inhibitor.
Time frame: Through study completion, an average of 1 year
Response to standard of care treatments after Week 13 Day 1.
Participants that still have active irAA symptoms of CTCAEv5.0 grade ≥1 after unblinding at Week 13 Day 1 visit who have a change in irAA therapy.
Time frame: From Week 13 Day 1 to Week 52.
Progression free survival
The time elapsed between randomization and tumor progression (radiographically or clinically) or death from any cause.
Time frame: Upon completion of follow-up period, an average of 3 years after intervention
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