Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Pati⦠(NCT04131426) | Clinical Trial Compass
CompletedPhase 1
Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia
United States25 participantsStarted 2020-04-24
Plain-language summary
The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 exercā¦
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]