Back to resultsEffect of an Oral Nutritional Supplement on Muscle Mass During Anticancer Treatment (ALLIES)
Primary Purpose
Colorectal Cancer (CRC), Non-small Cell Lung Cancer (NSCLC)
Status
Recruiting
Phase
Early Phase 1
Locations
Ireland
Study Type
Interventional
Intervention
an enriched high protein and high energy oral nutrition supplement (ONS)
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer (CRC) focused on measuring Muscle mass, oral nutritional supplement, colorectal cancer, non-small cell lung cancer
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 Participation in any other studies involving investigational or marketed products concomitantly or within 14 days prior to entry into the study
Sites / Locations
- UCCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test product
Control product
Arm Description
An enriched high protein and high energy oral nutrition supplement (ONS)
standard isocaloric high energy normal protein isocaloric ONS
Outcomes
Primary Outcome Measures
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
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)
between baseline and end of study [score], between the two interventions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05648955
Brief Title
Effect of an Oral Nutritional Supplement on Muscle Mass During Anticancer Treatment
Acronym
ALLIES
Official Title
Muscle Mass in Patients With Colorectal or Lung Cancer When Receiving an Oral Nutritional Supplement During Anti-cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer (CRC), Non-small Cell Lung Cancer (NSCLC)
Keywords
Muscle mass, oral nutritional supplement, colorectal cancer, non-small cell lung cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test product
Arm Type
Experimental
Arm Description
An enriched high protein and high energy oral nutrition supplement (ONS)
Arm Title
Control product
Arm Type
Active Comparator
Arm Description
standard isocaloric high energy normal protein isocaloric ONS
Intervention Type
Dietary Supplement
Intervention Name(s)
an enriched high protein and high energy oral nutrition supplement (ONS)
Intervention Description
NA (see intervention name)
Primary Outcome Measure Information:
Title
Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2]
Description
between baseline and after 12 weeks of intervention as measured with a CT scan, between the two interventions
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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)
Description
between baseline and end of study [score], between the two interventions.
Time Frame
~13 weeks
Other Pre-specified Outcome Measures:
Title
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)
Description
between baseline and end of study
Time Frame
~13 weeks
Title
Inflammation status
Description
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
Time Frame
~13 weeks
Title
Change in performance status ECOG
Description
between baseline and end of study [score]
Time Frame
~13 weeks
Title
Change in physical function
Description
between baseline and end of study: 30 seconds chair stand test [number]
Time Frame
~13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Participation in any other studies involving investigational or marketed products concomitantly or within 14 days prior to entry into the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danone Nutricia Research
Phone
+31 30 2095 000
Email
register.clinicalresearchnutricia@danone.com
Facility Information:
Facility Name
UCC
City
Cork
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of an Oral Nutritional Supplement on Muscle Mass During Anticancer Treatment
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