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

Early Phase 1

Recruiting

• Conditions: Colorectal Cancer (CRC); Non-small Cell Lung Cancer (NSCLC)
• Interventions: Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS)

• Registration Number: NCT05648955
• Lead Sponsor: Nutricia Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Study Start: 2023-03-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-28
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test product	an enriched high protein and high energy oral nutrition supplement (ONS)	An enriched high protein and high energy oral nutrition supplement (ONS)
Control product	an enriched high protein and high energy oral nutrition supplement (ONS)	standard isocaloric high energy normal protein isocaloric ONS

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UCC; 🇮🇪 Cork, Ireland