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

Nutricia Research1 site in 1 country118 target enrollmentMarch 31, 2023

ConditionsColorectal Cancer (CRC)Non-small Cell Lung Cancer (NSCLC)

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Colorectal Cancer (CRC)
Sponsor: Nutricia Research
Enrollment: 118
Locations: 1
Primary Endpoint: Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2]
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 31, 2023

End Date

June 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nutricia Research

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2]

Time Frame: 12 weeks

between baseline and after 12 weeks of intervention as measured with a CT scan, between the two interventions

Secondary Outcomes

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)