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Current Research Projects Supported by PEAK

A Pilot Randomized Trial of A Mobile Health Exercise Intervention for Older Patients with Myeloid Neoplasms

Study Chair: Dr. Kah Poh Loh

This phase II randomized controlled trial (RCT) to assess the preliminary efficacy of a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education control in 100 older patients with myeloid neoplasms receiving outpatient chemotherapy on physical function and patient-reported outcomes (fatigue, mood, and quality of life). We will also explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression.

An Exercise and Cognitive Rehabilitation Intervention for Older Cancer Survivors
(The E-Co Study)

Study Chair: Dr. Kah Poh Loh

The objective of the study is to evaluate the feasibility of a combined mobile health exercise and cognitive rehabilitation intervention and its effect on cognition in a single-arm pilot study that recruits cancer survivors.

Feasibility of a Dyadic Life Review Intervention for Older Patients with Advanced Cancer and Mild Cognitive Impairment (MCI) and their Caregivers

Study Chair: Dr. Lee Kehoe

The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with caregivers of older adults with advanced cancer, including those with Mild Cognitive Impairment (MCI). The study will enroll 20 dyads of caregivers and older patients with advanced cancer and 20 dyads of caregivers and patients with advanced cancer and MCI.

Longitudinal Changes in Neurocognitive Function and Neuropathy among Adolescent and Young Adult Hodgkin Lymphoma Patients

Study Chair: Dr. AnnaLynn Williams

This single-center longitudinal observational study aims to understand the trajectories of neurologic impairments (neuropathy and neurocognition) as well as physiologic (frailty) and biologic (inflammation, DNA methylation) aging in 71 adolescent and young adult patients (aged 15-39) with lymphoma undergoing first-line therapy. Understanding changes in neurocognition, neuropathy, frailty, and aging-related biomarkers will inform the natural history of these phenotypes and inform the design and timing of interventions to prevent or mitigate neurologic sequelae. 

Randomized Placebo Controlled Trial of Bupropion for Cancer Related Fatigue

Study Chairs: Dr. Luke Peppone, Dr. Heather Jim

Fatigue is one of the most prevalent and distressing symptoms experienced by cancer patients and treatment options for cancer-related fatigue are limited. The goal of this study is to conduct the first adequately powered, randomized, double-blinded, placebo-controlled trial of bupropion for cancer-related fatigue. Positive results from the study could improve fatigue and quality of life for large numbers of cancer patients.

Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Study Chairs: Dr. Po-Ju Lin, Dr. Ian Kleckner

Chemotherapy-induced peripheral neuropathy (CIPN) is a common, severe, dose-limiting, and tough-to-treat toxicity causing numbness, tingling, pain, and cramping in the hands and feet. This phase II clinical trial will recruit 120 patients with CIPN to test the effects of exercise on CIPN and to examine the role of the brain in CIPN, which has been understudied and may help transform our understanding of CIPN.

Optimizing Functional Outcomes of Older Cancer Survivors after Chemotherapy (GEMS)

Study Chairs: Dr. Karen Mustian, Dr. Supriya Mohile, Dr. Michelle Janelsins

This study compares the effect of a clinician-driven, aging-sensitive geriatric evaluation and management with survivorship health education (GEMS) program to usual survivorship care on patient-reported physical function in older cancer survivors. Survivors and their care partners in the GEMS arm receive tailored recommendations based on their geriatric assessment and participate in a survivorship health education program twice a week for 4 weeks.

Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)

Study Chairs: Dr. Karen Mustian, Dr. Oxana Palesh

Insomnia is extremely prevalent and undertreated in cancer patients and survivors, nearly 80% of those diagnosed with cancer will have insomnia symptoms that interfere with health-related quality of life and other aspects of functioning. The aim of this phase III multicenter clinical trial is to evaluate the effectiveness of brief behavioral therapy for cancer-related insomnia in reducing insomnia compared to the healthy eating education control condition in 400 cancer survivors.

Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting

Study Chairs: Dr. Charles Kamen, Dr. Song Yao

Immune checkpoint inhibitors (ICIs) use the body’s own immune response to fight cancer. Because immune response is generally stronger in patients of African ancestry (AA) than European ancestry (EA), AA patients may have more negative side effects from ICIs but may also respond better to them. In this study, we will follow a large group of AA and EA patients on ICIs over time in order to understand these racial differences and to see what other patient factors may predict these differences. The long-term goal is to ensure that all patients can benefit from new treatments for their cancer through appropriate management of side effects.

High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients (ViPER)

Study Chair: Dr. Luke Peppone

The use of androgen deprivation therapy (ADT), which causes near-total loss of testosterone, has increased dramatically in elderly prostate cancer patients over the last decade. ADT is associated with a significant increase in bone mineral density (BMD) loss and bone fractures, combined with a significant decrease in muscle mass. Vitamin D protects against BMD loss and fractures, but currently recommended supplementation levels (600-800 IU/day) are inadequate to protect against bone loss in a high-risk population such as prostate cancer patients on ADT. High-dose vitamin D supplementation has shown promise, but results are limited. To address this, we are conducting a multi-center, phase III RCT in which 366 prostate cancer patients ≥65 years old starting ADT with vitamin D <27 ng/ml will be randomized to 1) 50,000 IU/week vitamin D or 2) a matching placebo for 52 weeks. All participants will receive a daily supplementation (800 IU vitamin D/1,000 mg calcium) to ensure a minimum of 100% RDA. The primary outcome is the change in BMD, while secondary outcomes include changes in the clinically relevant outcomes of falls, balance, quality of life, and fractures. If high-dose vitamin D was found to be efficacious, it would be a safe, low-cost, widely available, non-pharmacologic treatment that could drastically improve the prevention of ADT-induced bone loss and change clinical practice paradigms.

Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia (LOTUS-CC)

Study Chair: Dr. Richard Dunne

The LOTUS-CC trial is an observational study that aims to develop new diagnostic subtypes of cancer cachexia. Cancer cachexia is a debilitating syndrome that results in weight and muscle loss, weakness, fatigue, poor quality of life, and reduced life expectancy. Many clinical trials for cancer cachexia therapies have been unsuccessful in the past and there are no FDA-approved treatments for cachexia. We hypothesize that one of the reasons for this lack of success is the broad diagnostic criteria and the prevailing thought that cancer cachexia is one disease entity with potential one-size-fits-all therapies. Our study seeks to challenge this and aims to discover unique characteristics among different subtypes of cachexia so that clinical trials and treatment may be better tailored for individuals with cachexia in the future. Target enrollment for this study includes patients with advanced or metastatic colorectal, lung, or pancreatic cancers. Participants do not need to be suffering from cachexia at enrollment to participate as we are hoping to learn from participants who never developed cachexia, those who develop cachexia during the course of the study, and those suffering from cachexia at the start of the study and may experience worsening, stability, or improvement.