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

Phase

Condition

N/A

Treatment

an enriched high protein and high energy oral nutrition supplement (ONS)

Clinical Study ID

NCT05648955

MPR15ON89540

Ages > 18
All Genders

Study 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

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 plannedduration of at least 9 weeks
Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
Age ≥ 18 years

Exclusion

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 terminalileum which does not affect absorption of nutrients other than sodium, potassium, andwater, in the opinion of the investigator)
Allergy to cow's milk protein, soy or fish, requiring a fibre-free diet or sufferinggalactosemia 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 complywith the protocol requirements
Participation in any other studies involving investigational or marketed productsconcomitantly or within 14 days prior to entry into the study

Study Design