Impact of a nutritional supplement on muscle mass in cancer patients
Muscle Mass in Patients With Colorectal or Lung Cancer When Receiving an Oral Nutritional Supplement During Anti-cancer Treatment
This study is testing whether a special high-protein nutritional supplement can help cancer patients with advanced colorectal or lung cancer keep their muscle mass during treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nutricia Research Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Cork) |
| Trial ID | NCT05648955 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of an enriched high protein and high energy oral nutritional supplement on maintaining skeletal muscle mass in patients diagnosed with stage III or IV colorectal or non-small cell lung cancer undergoing systemic treatment. The trial focuses on patients scheduled for their first cycle of treatment, aiming to address the common issue of malnutrition and sarcopenia in this population. By providing nutritional support, the study seeks to improve clinical outcomes associated with muscle mass preservation during cancer therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage III or IV colorectal or non-small cell lung cancer who are starting their first cycle of systemic treatment.
Not a fit: Patients who have experienced significant weight loss, have a high body mass index, or are receiving other forms of nutritional support may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve muscle mass and overall health outcomes for cancer patients undergoing treatment.
How similar studies have performed: Other studies have shown promising results in using nutritional supplements to combat muscle loss in cancer patients, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cork
- Ucc — Cork, Ireland (Recruiting)
Study contacts
- Study coordinator: Danone Nutricia Research
- Email: register.clinicalresearchnutricia@danone.com
- Phone: +31 30 2095 000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.