Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Smartfish AS

Criteria

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.