Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia
The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.
Checked against the public recordLast updated Aug 15, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- University of Rochester
- Interventions being studied
- Drug: Remune; Other: EXCAP©®
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Be over the age of 18 years and have a primary diagnosis of colorectal, esophageal, gastric, pancreatic, biliary tract cancer (includes cholangiocarcinoma, gallbladder cancer, and ampullary cancer), or Non-small cell lung cancer (NSCLC) with plans to initiate systemic chemotherapy, targeted therapy or immunotherapy within the next 4 weeks after enrollment. * Have been diagnosed as having an unresectable cancer with no plans for surgical intervention during the active study period (12 weeks). * Have an ECOG performance score of 0 or 1. * Have a life expectancy of \>3 months as determined by their primary oncologist. * Have experienced at least 2% weight loss of the patient's reported previous body weight over the 6 months prior to enrollment. * Have permission from primary oncologist to engage in low to moderate intensity exercise regimen. * Be able to read English (since the assessment materials are in printed format). * Be able to give written informed consent. Exclusion Criteria: * Have any of the following limitations: unable to perform low-to-moderate intensity exercise regimen. * Have had major surgery (excluding diagnostic procedures like laparoscopy, EGD/EUS, esophageal stent placement) in the past 4 weeks. * Be experiencing dysphagia that requires enteral or parenteral feeding for nutrition. * Be enrolled on hospice at time of consent. * Be engaged in an active exercise routine by being identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form (67). * Use of nutritional supplements containing EPA/DHA within 2 weeks prior to screening * Current Use of Vitamin D supplementation or St. John's wort that can influence efficacy and safety parameters. Chronic treatment (\>12 weeks prior to screening) with multivitamin tablets is allowed (vitamin tablets must not contain more vitamin D than 150% of the recommended dietary allowance \[RDA\]). * Known hypersensitivity or allergy to any of the study products. Specifically, patients allergic to milk, fish or shellfish will be excluded. * Have AST/ALT \>3x upper limit of normal (ULN) or \>5xULN in those with liver metastases, Serum creatinine \>2x ULN, Absolute Neutrophil Count \<1,500/uL, Hemoglobin \<9, Platelet count \<75,000/uL at the time of baseline blood draw or any other Blood chemistry or hematology lab abnormalities that would exclude them from being able to receive standard chemotherapy or interventional clinical trial. * Have uncontrolled Diabetes Mellitus as determined by primary oncologist or PI.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of RochesterRochester, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 15, 2023. Always confirm current availability with the study team.