Clinical Research Directory

Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors

This single-site, randomized pilot study will evaluate whether intermittent fasting is feasible and safe for patients with advanced solid tumors who are starting immune checkpoint inhibitor (ICI) therapy at the WVU Cancer Institute. Participants will be assigned to 1 of 3 groups: usual care with no fasting, alternate-day fasting (ADF), or time-restricted eating (TRE). Participants in the ADF group will follow cycles of 12 hours of eating followed by 36 hours of fasting every other day. Participants in the TRE group will eat all daily calories within an 8-hour window each day. The fasting intervention will begin within 1 week of starting ICI treatment and continue for approximately 20-24 weeks during 8 cycles of therapy. The study will evaluate adherence to the fasting regimens and compare side effects between groups. Researchers will also study changes in metabolic and immune biomarkers, fatigue, sleep, and quality of life. Participants will be followed for 30 days after completion of the intervention to monitor safety and tolerability.

Organotypic Platform for Therapeutic Investigation (OPTin) for Guiding Cancer Patients Treatment

The goal of this clinical trial is to learn whether a new laboratory method called OPTin can help doctors select the most effective, personalized cancer therapies for patients with advanced or treatment-resistant tumors. The study will also learn about the safety and feasibility of using OPTin to guide treatment decisions across different cancer types. The main questions it aims to answer are: Does OPTin accurately identify which drugs or drug combinations work best for each patient's tumor? Does OPTin-guided therapy improve tumor response or remission rates when the patients don't have any standard treatment selection? Study Design: Researchers will collect treatment outcomes in patients whose therapy is chosen based on OPTin results or not in cancer patients without standard treatment. Participants will: Provide a small tumor tissue sample for OPTin testing. Receive either a drug or drug combination identified by OPTin, or a physician's decision treatment. Visit the clinic regularly for imaging, blood tests, and side-effect monitoring. Be followed for several months to evaluate treatment response and overall health. Example Case: In a previous proof-of-concept study, OPTin screening in a patient with advanced hypopharyngeal carcinoma identified venetoclax as effective for the primary tumor and lenvatinib as a sensitizing agent for metastasis. Combination therapy led to near-complete remission and a significant drop in serum AFP levels. These results support evaluating OPTin in a prospective clinical trial involving diverse cancer types to confirm its usefulness in guiding precision oncology.

WellSpan-THRIVE Cancer QOL Study

Cancer affects millions of people worldwide and can significantly impact not only survival, but also day-to-day quality of life. Treatments such as surgery, chemotherapy, and radiation can cause side effects like fatigue, pain, and neuropathy, which may affect physical function, emotional well-being, and social relationships. While many studies have examined factors that influence quality of life; such as age, type and stage of cancer, and treatment-related symptoms; there is still a need for tools that more fully reflect patients' lived experiences. This study aims to develop and implement a patient-centered quality of life (QOL) survey designed specifically for individuals with cancer. By directly involving patients in sharing what matters most to them, the survey seeks to provide a more complete and accurate understanding of how cancer and its treatment affect daily life. The results will help patients, families, and healthcare providers better identify needs, guide supportive care, and improve overall well-being throughout the cancer journey.