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

Launched by NUTRICIA RESEARCH · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether an oral nutritional supplement can help maintain muscle mass in patients undergoing treatment for advanced colorectal cancer or non-small cell lung cancer. Maintaining muscle mass is important because losing muscle can lead to worse health outcomes during cancer treatment. The trial is currently looking for participants aged 18 and older who are diagnosed with stage III or IV colorectal or lung cancer and are starting their first round of systemic treatments, like chemotherapy or immunotherapy.

If you decide to participate, you will receive the nutritional supplement alongside your cancer treatment. However, there are some criteria you need to meet to join, such as not having lost more than 10% of your weight in the last six months and not having a Body Mass Index (BMI) over 30. Additionally, individuals with certain health conditions, allergies, or who are pregnant cannot participate. This trial is a great opportunity to contribute to important research that may help improve the care of cancer patients.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of stage III or IV colorectal or non-small cell lung cancer
• • Scheduled for the first cycle of any line of a systemic treatment: chemotherapy, concurrent chemoradiotherapy, immunotherapy or targeted treatment with a planned duration of at least 9 weeks
• • Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
• • Age ≥ 18 years
• Exclusion Criteria:
• • Weight loss \>10% in the last 6 months
• • Body Mass Index \> 30.0 kg/m2
• • Life expectancy \< 3 months
• • Receiving enteral (tube) or parenteral nutrition
• • Presence of ileostoma or ileal pouch (except for an ileostomy at or near the terminal ileum which does not affect absorption of nutrients other than sodium, potassium, and water, in the opinion of the investigator)
• • Allergy to cow's milk protein, soy or fish, requiring a fibre-free diet or suffering galactosemia or lactose intolerance
• • Known pregnancy or lactation
• • Current alcohol or drug abuse in the opinion of the investigator
• • Wearing an electronic implant and/or pacemaker
• • Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• • Participation in any other studies involving investigational or marketed products concomitantly or within 14 days prior to entry into the study