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

Study Overview
=================
Brief 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.

Official Title
-----------------
Muscle Mass in Patients With Colorectal or Lung Cancer When Receiving an Oral Nutritional Supplement During Anti-cancer Treatment

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

Intervention / Treatment
-----------------
* Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product<br>An enriched high protein and high energy oral nutrition supplement (ONS) | Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS)<br>* NA (see intervention name)<br>|
| Active Comparator: Control product<br>standard isocaloric high energy normal protein isocaloric ONS | Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS)<br>* NA (see intervention name)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2] | between baseline and after 12 weeks of intervention as measured with a CT scan, between the two interventions | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life as measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30 global health score) | between baseline and end of study [score], between the two interventions. |  13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle mass, oral nutritional supplement, colorectal cancer, non-small cell lung cancer