Optimizing Ancillary Therapies (Acetaminophen, Cannabis, Antihistamines, and NSAIDS) With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)
Val Adams
Summary
This study evaluates whether optimization of ancillary therapies can improve the efficacy of immune checkpoint therapy in participants with solid tumors. The ancillary therapies being optimized include the avoidance of daily acetaminophen and cannabis/THC/CBD while prescribing aspirin and loratadine. The goal is to see if optimizing these four drugs can improve the efficacy of the treatment compared to a matched historical control.
Description
There are multiple reports of ancillary drugs impacting the efficacy of immune checkpoint inhibitor therapy. However, there are no prospective studies evaluating the potential benefit of optimizing multiple ancillary therapies in a prospective study. To address this gap in knowledge the approach is to compare two groups; the first group is a prospective interventional population consisting of 98 solid tumor patients who have radiologically measurable cancer which are scheduled to receive immunotherapy as part of the participant's cancer treatment. Enrolled patients will be asked to avoid daily…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Solid tumor patients with measurable disease. Including patients with early stage and advanced stage cancer. * Patients who are to get neoadjuvant or induction therapy prior to planned surgery or radiation are included if definitive therapy is planned to occur at least 18 weeks after ICI initiation. * Treatment plan includes an immune checkpoint inhibitor (PD1 or PD-L1 inhibitor) as standard of care. Standard of care will be determined by referring to the NCCN guidelines. For rare situations where a disease is not found in the NCCN guideline, the treatment must be consid…
Interventions
- DrugAsprin
Participants will receive Aspirin or continue an equivalent NSAID as part of the OAT ICI protocol while receiving standard-of-care immune checkpoint inhibitor therapy.
- DrugLoratadine
Participants will receive Loratadine or continue an equivalent antihistamine as part of the OAT ICI protocol while receiving standard-of-care immune checkpoint inhibitor therapy.
- BehavioralAcetaminophen Avoidance
Participants will be instructed to avoid acetaminophen-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.
- BehavioralTHC Avoidance
Participants will be instructed to avoid THC-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.
Location
- University of Kentucky Markey Cancer CenterLexington, Kentucky