Colorectal Cancer (CRC)Early Phase 1ALLIESNCT05648955
Effect of an Oral Nutritional Supplement on Muscle Mass During Anticancer Treatment
A Early Phase 1 study testing an enriched high protein and high energy oral nutrition supplement (ONS) in people with Colorectal Cancer (CRC) and Non-small Cell Lung Cancer (NSCLC), run by Nutricia Research at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (CRC), Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- an enriched high protein and high energy oral nutrition supplement (ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteIreland
- Study dates
- 31 Mar 2023to 30 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscle Mass in Patients With Colorectal or Lung Cancer When Receiving an Oral Nutritional Supplement During Anti-cancer Treatment
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.
- Being tested
- an enriched high protein and high energy oral nutrition supplement (ONS)
- Keywords
- Muscle mass, oral nutritional supplement, colorectal cancer, non-small cell lung cancer
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an enriched high protein and high energy oral nutrition supplement (ONS)Dietary supplement
NA (see intervention name)
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | An enriched high protein and high energy oral nutrition supplement (ONS) Receives: Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS) |
| Control product | Active comparator | standard isocaloric high energy normal protein isocaloric ONS Receives: Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: ~13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start31 Mar 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648955
- Sponsor's protocol ID
- MPR15ON89540
- Acronym
- ALLIES
- Status last verified
- Jul 2023
- First submitted
- 10 Aug 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Mass in Patients With Colorectal or Lung Cancer When Receiving an Oral Nutritional Supplement During Anti-cancer Treatment
- ClinicalTrials.gov ID
- NCT05648955
- Acronym / sponsor ID
- ALLIES / MPR15ON89540
- Keywords
- Muscle mass, oral nutritional supplement, colorectal cancer, non-small cell lung cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS)An enriched high protein and high energy oral nutrition supplement (ONS) |
| Control product | Active comparator | Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS)standard isocaloric high energy normal protein isocaloric ONS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| an enriched high protein and high energy oral nutrition supplement (ONS)NA (see intervention name) | Dietary supplement | Control product, Test product |
Primary outcome
Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2]
Time frame: 12 weeks
between baseline and after 12 weeks of intervention as measured with a CT scan, between the two interventions
1 secondary outcome
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)
Time frame: ~13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer (CRC)
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing an enriched high protein and high energy oral nutrition supplement (ONS) in people with Colorectal Cancer (CRC) and Non-small Cell Lung Cancer (NSCLC), run by Nutricia Research at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danone Nutricia Research (+31 30 2095 000, register.clinicalresearchnutricia@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2] (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.