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

Sponsor

Nutricia Research (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05648955

Collaborator

(none)

118

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer (CRC) Non-small Cell Lung Cancer (NSCLC)	Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS)	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of stage III or IV colorectal or non-small cell lung cancer
Scheduled for 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
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