CancerNCT06698783
Practical Application and Evaluation of Fortimel in Oncology Patients
A study testing Fortimel in people with Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a multicenter registry and is a prospective, observational, real-world study. Subjects were selected by clinicians for oral ONS nutritional intervention according to the actual clinical situation and the patient's wishes, and the observation period was 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Fortimel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Jan 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients signed informed consent and volunteered to participate in the study
- Patients diagnosed with colorectal cancer or primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring, undifferentiated adenocarcinoma) or NSCLC stage I-iv. by histopathological examination of primary biopsy
- Cancer patients who were receiving chemoradiotherapy or immunotherapy were given 2 points for nutritional risk screening, and patients who met the conditions of ONS nutrition intervention were voluntarily enrolled to receive ONS nutrition intervention with Nertronecar
- Basic reading and communication skills
- The expected survival time is greater than 6 months
Who cannot join
- Combined cognitive dysfunction, mental disorder, impaired consciousness or unwillingness to partner
- Contraindications with chemotherapy or immunotherapy
- Prolonged bed rest, hemiplegia, or coma
- Intolerance of allergies to nutrients or their main components, such as lactose or galactose
- In the case of severe gastrointestinal symptoms of liver and kidney dysfunction, the serum creatinine glutamic pyruvic transaminase glutamic oxalacetic transaminase increases by more than 2.5 times, and the fasting blood glucose is over10mmol
Trial locations and contacts
1 site in 1 country.
China1 site
Dongcheng district，Peking union medical college hospital
Beijing, Beijing Municipality, 100010
About this study
Official title: Practical Application and Evaluation of Fortimel Taste Optimization Nutritional Support in Oncology Patients: a Multicenter Real-World Study
This study is a multicenter registry and is a prospective, observational, real-world study.
Subjects were selected by clinicians for oral ONS nutritional intervention according to the actual clinical situation and the patient's wishes, and the observation period was 4 weeks.
Read more
Subjects will receive a ready-to-drink marketed formula for special medical purposes with 4 flavors for free Food liquid preparation (Nengli Yijia, Nutricia in the Netherlands) for rounds of nutritional intervention, providing
1 flavor per week, 1-2 bottles per day, 4 flavors for a total of 28 days. The basic nutritional status and quality of life of patients were mainly evaluated at multiple time nodes before and after nutritional intervention.
In order to improve the compliance of subjects, the all-round guardian platform (hereinafter referred to as the platform) by the China Initial Insurance Foundation was used during the intervention period to provide basic nutrition supervision, education and dietary guidance in routine nutrition support.
Recruitment method: Convenient sampling method is adopted, from the beginning of recruitment to the target sample size.
Follow-up period: After the start of the intervention, it will be carried out according to the plan of the follow-up task to the end of the intervention on the 28th day. The last telephone follow-up visit will complete on the 60th day after the end of the pre-end.
- Conditions
- Cancer
- Being tested
- Fortimel
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FortimelDietary supplement
In this study, patients will be provided with ONS preparation (4 kinds of ready-to-drink special medical food) free of charge during the treatment period. Doctors will provide patients with different flavor nutritional preparations on a weekly basis, 2 bottles per day for patients with 1 flavor per week, and 14 bottles per day for each of 4 flavors at the recommended dosage of 400 kcal per day 28 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Dietary Supplement: Fortimel |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
weight measured by body composition analyzer
Measured: One week before intervention and day 1, day 14 and day 28 of intervention.
fat-free mass index
fat-free mass index measured by body composition analyzer
Measured: One week before intervention and day 1, day 7,day 14,day 21, and day 28 of intervention.
skeletal muscle index
skeletal muscle index measured by body composition analyzer
Measured: One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention.
food intake change
calculated from recorded food intake through an online tool
Measured: One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention.
Secondary outcomes (4)
Satiety
VAS score
Measured: Day 1, day 14,and day 28 of intervention
Gastrointestinal reactions
enteral nutrition tolerance scale tool
Measured: Day 1, day 14,and day 28 of intervention
Adherence to nutritional formulations
using the patient's ONS compliance register
Measured: Day 1, day 14,and day 28 of intervention
24h dietary intake
Measured: Day 1, day 14,and day 28 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698783
- Sponsor's protocol ID
- K6287
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Application and Evaluation of Fortimel Taste Optimization Nutritional Support in Oncology Patients: a Multicenter Real-World Study
- ClinicalTrials.gov ID
- NCT06698783
- Acronym / sponsor ID
- K6287
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 21 Nov 2024 (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.
This study is a multicenter registry and is a prospective, observational, real-world study.
Subjects were selected by clinicians for oral ONS nutritional intervention according to the actual clinical situation and the patient's wishes, and the observation period was 4 weeks.
Subjects will receive a ready-to-drink marketed formula for special medical purposes with 4 flavors for free Food liquid preparation (Nengli Yijia, Nutricia in the Netherlands) for rounds of nutritional intervention, providing
1 flavor per week, 1-2 bottles per day, 4 flavors for a total of 28 days. The basic nutritional status and quality of life of patients were mainly evaluated at multiple time nodes before and after nutritional intervention.
In order to improve the compliance of subjects, the all-round guardian platform (hereinafter referred to as the platform) by the China Initial Insurance Foundation was used during the intervention period to provide basic nutrition supervision, education and dietary guidance in routine nutrition support.
Recruitment method: Convenient sampling method is adopted, from the beginning of recruitment to the target sample size.
Follow-up period: After the start of the intervention, it will be carried out according to the plan of the follow-up task to the end of the intervention on the 28th day. The last telephone follow-up visit will complete on the 60th day after the end of the pre-end.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Fortimel |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients signed informed consent and volunteered to participate in the study
- Patients diagnosed with colorectal cancer or primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring, undifferentiated adenocarcinoma) or NSCLC stage I-iv. by histopathological examination of primary biopsy
- Cancer patients who were receiving chemoradiotherapy or immunotherapy were given 2 points for nutritional risk screening, and patients who met the conditions of ONS nutrition intervention were voluntarily enrolled to receive ONS nutrition intervention with Nertronecar
- Basic reading and communication skills
- The expected survival time is greater than 6 months
Key exclusion criteria (5 listed)
- Combined cognitive dysfunction, mental disorder, impaired consciousness or unwillingness to partner
- Contraindications with chemotherapy or immunotherapy
- Prolonged bed rest, hemiplegia, or coma
- Intolerance of allergies to nutrients or their main components, such as lactose or galactose
- In the case of severe gastrointestinal symptoms of liver and kidney dysfunction, the serum creatinine glutamic pyruvic transaminase glutamic oxalacetic transaminase increases by more than 2.5 times, and the fasting blood glucose is over10mmol
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 |
|---|---|---|
| FortimelIn this study, patients will be provided with ONS preparation (4 kinds of ready-to-drink special medical food) free of charge during the treatment period. Doctors will provide patients with different flavor nutritional preparations on a weekly basis, 2 bottles per day for patients with 1 flavor per week, and 14 bottles per day for each of 4 flavors at the recommended dosage of 400 kcal per day 28 days | Dietary supplement | Intervention group |
Primary outcome
weight
Time frame: One week before intervention and day 1, day 14 and day 28 of intervention.
weight measured by body composition analyzer
fat-free mass index
Time frame: One week before intervention and day 1, day 7,day 14,day 21, and day 28 of intervention.
fat-free mass index measured by body composition analyzer
skeletal muscle index
Time frame: One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention.
skeletal muscle index measured by body composition analyzer
food intake change
Time frame: One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention.
calculated from recorded food intake through an online tool
4 secondary outcomes
Satiety
Time frame: Day 1, day 14,and day 28 of intervention
Gastrointestinal reactions
Time frame: Day 1, day 14,and day 28 of intervention
Adherence to nutritional formulations
Time frame: Day 1, day 14,and day 28 of intervention
24h dietary intake
Time frame: Day 1, day 14,and day 28 of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortimel in people with Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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 5 inclusion and 5 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 21 Nov 2024. 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 China. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: One week before intervention and day 1, day 14 and day 28 of intervention.). The study lists 4 primary outcomes in all. 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 21 Nov 2024.