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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

— ALLIES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648955
• Other study ID #: MPR15ON89540
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 31, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Nutricia Research
• Contact: Danone Nutricia Research
• Phone: +31 30 2095 000
• Email: register.clinicalresearchnutricia[@]danone.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer (CRC)
• Colorectal Neoplasms
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Dietary Supplement:
• an enriched high protein and high energy oral nutrition supplement (ONS)
NA (see intervention name)

Locations

Country	Name	City	State
Ireland	UCC	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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 0; CRP > 10 mg/L and albumin = 35 g/L -> score 1; CRP > 10 mg/L and albumin < 35 g/L -> score 2	~13 weeks
Other	Change in performance status ECOG	between baseline and end of study [score]	~13 weeks
Other	Change in physical function	between baseline and end of study: 30 seconds chair stand test [number]	~13 weeks
Primary	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	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