This phase II trial studies how well the effects of exercise and nutrition interventions work on the side effects of chemotherapy in patients with gastrointestinal cancer. Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and treatment for their cancer. Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy. Not only does CIPN increase mortality by limiting the dose of chemotherapy, CIPN affects walking, writing, eating, and dressing via numbness, tingling, pain, cold sensitivity, and cramping in the hands and feet. Unfortunately there are very limited treatments for CIPN. This study may help researchers determine the impact of an exercise and nutritional intervention on CIPN in patients with gastrointestinal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05452902.
Locations matching your search criteria
United States
Maryland
Baltimore
University of Maryland/Greenebaum Cancer CenterStatus: Active
Contact: Ian R. Kleckner
Phone: 410-706-5981
Bel Air
UM Upper Chesapeake Medical CenterStatus: Active
Contact: Ian R. Kleckner
Glen Burnie
UM Baltimore Washington Medical Center/Tate Cancer CenterStatus: Active
Contact: Ian R. Kleckner
Towson
UM Saint Joseph Medical CenterStatus: Active
Contact: Ian R. Kleckner
PRIMARY OBJECTIVES:
I. Assess the preliminary efficacy of exercise versus (vs.) nutrition education control on patient-reported CIPN (via CIPN-20 questionnaire).
II. Assess the preliminary efficacy of exercise vs. nutrition education control on clinical assessments of CIPN (via tactile sensitivity test and cold stimulation test).
III. Assess the preliminary efficacy of exercise vs. nutrition education control on interoception (functional magnetic resonance imaging [fMRI] functional connectivity in the interoceptive brain system and multidimensional assessment of interoceptive awareness-2 [MAIA-2] questionnaire).
IV. Assess the preliminary efficacy of exercise vs. nutrition education control on inflammation (IL-1beta, IL-1RA, IL-6, IL-8, IL-10, and IFNgamma in serum via Luminex).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a 45-60 minute exercise instruction session and complete an at-home progressive walking and resistance exercise program over 12 weeks. Patients wear a Fitbit, receive phone calls, and undergo blood sample collection on study. Patients may also undergo magnetic resonance imaging (MRI) while on study.
ARM II: Patients receive a 45-60 minute nutritional instruction session consisting of eating tips and food intake tracking to implement over 12 weeks. Patients wear a Fitbit, receive phone calls, and undergo blood sample collection on study. Patients may also undergo MRI while on study.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
Principal InvestigatorIan R. Kleckner