Evaluating Hydroxychloroquine with Prednisone vs Prednisone Alone for Immune-Related Joint Pain in Cancer Patients

What this Trial Is About

Researchers are investigating treatments for joint pain, stiffness, and swelling caused by cancer therapies that target the immune system. These symptoms can range from mild to severe and sometimes require stopping cancer treatment. The study aims to compare the effects of hydroxychloroquine combined with prednisone versus prednisone alone to determine which approach may better manage joint pain related to immune therapy side effects. Participants will receive either hydroxychloroquine at a dose of 5 mg per kilogram daily along with prednisone starting at 20 mg daily for 8 weeks with a tapering dose, or a matching placebo with the same prednisone regimen. This is a double-blinded, randomized study where neither participants nor researchers know who is receiving hydroxychloroquine or placebo until after 12 weeks of treatment. After this period, the treatment assignments will be revealed. During the study, participants will be monitored for recurrence of moderate or worse immune-related arthritis or joint pain over about one year. Researchers will track steroid usage, other immune-related side effects, adverse events, and cancer progression. Follow-up will continue for up to three years after treatment to assess long-term outcomes. Participants will have regular assessments to evaluate their condition and treatment effects throughout the study period.

Immune-Mediated Pathophysiology And Clinical Triage Program