Colorectal Cancer (CRC), Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Muscle mass, oral nutritional supplement, colorectal cancer, non-small cell lung cancer
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.
Interventions
DIETARY_SUPPLEMENTan enriched high protein and high energy oral nutrition supplement (ONS)
NA (see intervention name)
Sponsors
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2] | 12 weeks | between baseline and after 12 weeks of intervention as measured with a CT scan, between the two interventions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | ~13 weeks | between baseline and end of study \[score\], between the two interventions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | ~13 weeks | between baseline and end of study |
| Inflammation status | ~13 weeks | at baseline, visit 2, visit 3 and end of study (visit 5): * Neutrophil/lymphocyte ratio * CRP \[mg/L\] * Albumin \[g/L\] * Modified Glasgow Prognostic Score (mGPS) \[score 0/1/2\] * CRP ≤ 10 mg/L and albumin ≥ 35 g/L or CRP ≤ 10 mg/L and albumin \< 35 g/L -\> score 0 * CRP \> 10 mg/L and albumin ≥ 35 g/L -\> score 1 * CRP \> 10 mg/L and albumin \< 35 g/L -\> score 2 |
| Change in performance status ECOG | ~13 weeks | between baseline and end of study \[score\] |
| Change in physical function | ~13 weeks | between baseline and end of study: 30 seconds chair stand test \[number\] |
Countries
Ireland
Contacts
Primary ContactDanone Nutricia Research
Outcome results
None listed