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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC)
• Intervention / Treatment: Dietary supplement: an enriched high protein and high energy oral nutrition supplement (ONS)

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Danone Nutricia Research; Phone Number: +31 30 2095 000; Email: register.clinicalresearchnutricia@danone.com

Study Locations

• Ireland
  • Cork, Ireland
    • Recruiting
    • UCC
    • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Other 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	~13 weeks
Inflammation status	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 0CRP > 10 mg/L and albumin ≥ 35 g/L -> score 1CRP > 10 mg/L and albumin < 35 g/L -> score 2	~13 weeks
Change in performance status ECOG	between baseline and end of study [score]	~13 weeks
Change in physical function	between baseline and end of study: 30 seconds chair stand test [number]	~13 weeks

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: colorectal cancer; non-small cell lung cancer; Muscle mass; oral nutritional supplement
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms
• Other Study ID Numbers: MPR15ON89540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No