Clinical trial · Interventional
Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia
Evaluating the Effects of Dietary Supplementation With Remune on Cancer Associated Weight and Muscle Loss With and Without Exercise: A Randomized Pilot Feasibility Study.
NCT04131426CI-TRIAL-00068827completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia; Cancer | — | UNRESOLVED | — |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EXCAP©® | Other | — | UNRESOLVED |
| Remune | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Remune dosed twice daily
- description
- A nutritional supplement taken twice per day each day and standard care for your cancer as prescribed by your oncologist
- interventionNames
- Drug: Remune
- type
- EXPERIMENTAL
- label
- Remune dosed twice daily and daily exercise with EXCAP
- description
- A nutritional supplement taken twice by day each day and a home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist
- interventionNames
- Drug: Remune
- Other: EXCAP©®
- type
- NO_INTERVENTION
- label
- Usual Care
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.