Clinical trial NCT05648955: Effect of an Oral Nutritional Supplement on Muscle Mass During Anticancer Treatment
Official title: Muscle Mass in Patients With Colorectal or Lung Cancer When Receiving an Oral Nutritional Supplement During Anti-cancer Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Colorectal Cancer (CRC)
Non-small Cell Lung Cancer (NSCLC)
Keywords: Muscle mass
oral nutritional supplement
colorectal cancer
non-small cell lung cancer
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2022-12-13
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2]
timeFrame: 12 weeks
Secondary outcomes:
measure: 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)
timeFrame: ~13 weeks
Other outcomes:
measure: 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)
timeFrame: ~13 weeks
measure: Inflammation status
timeFrame: ~13 weeks
measure: Change in performance status ECOG
timeFrame: ~13 weeks
measure: Change in physical function
timeFrame: ~13 weeks
Locations:
city: Cork
country: Ireland
facility: UCC
Study officials:
References: