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Not Yet Recruiting NCT05648955

Effect of an Oral Nutritional Supplement on Muscle Mass During Anticancer Treatment

Conditions: Colorectal Cancer (CRC), Non-small Cell Lung Cancer (NSCLC)

Sex: All
Ages: 18 Years – N/A
Phase: EARLY_PHASE1
Enrollment: 118
Sponsor: Nutricia Research

Summary

Malnutrition and low muscle mass (sarcopenia) are common problems in patients with cancer. However, a low muscle mass is associated with negative clinical outcomes in patients with cancer. Therefore, it is very important to maintain muscle mass in this population. This study aims to investigate the effect of an oral nutritional supplement on skeletal muscle mass during anti-cancer treatment.

Eligibility Criteria

Inclusion Criteria:Diagnosis of stage III or IV colorectal or non-small cell lung cancerScheduled for systemic treatment: chemotherapy, concurrent chemoradiotherapy, immunotherapy or targeted treatment with a planned duration of at least 9 weeksPerformance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1Age ≥ 18 yearsExclusion Criteria:Weight loss >10% in the last 6 monthsBody Mass Index > 30.0 kg/m2Life expectancy < 3 monthsReceiving enteral (tube) or parenteral nutritionPresence of ileostoma or ileal pouchAllergy to cow's milk protein, soy or fish, requiring a fibre-free diet or suffering galactosemia or lactose intoleranceKnown pregnancy or lactationCurrent alcohol or drug abuse in the opinion of the investigatorWearing an electronic implant and/or pacemakerInvestigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirementsParticipation in any other studies involving investigational or marketed products concomitantly or within 14 days prior to entry into the study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05648955). StuddyBuddy aggregates publicly available trial information.