MalnutritionNCT04184713
Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Cancer and Malnutrition
A study testing Experimental Group in people with Malnutrition and Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition Read more about this study
- Who is it for?
- Ages 28 years and older
- Conditions the study is for
- Malnutrition, Cancer, Nutrition Related Cancer
- What is being tested?
- Experimental Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 1 Aug 2020
- 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 28 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 with a cancer diagnosis (any type).
- Subjects who have initiated during the next mont a treatment with chemo and or radiotherapy with or without surgery.
- Having lost more than 5% of body weight in the last 6 months.
- Adequate cultural level and understanding for the clinical trial.
- Signed informed consent.
Who cannot join
- Subjects who are participating in other clinical trials.
- Subjects with morbid obesity.
- Subjects who will undergo surgery or who will undergo.
- Subjects with cachexia
- Subjects with infection of a cause other than of the tumor
- Subjects with an infectious process
Show all 15Show fewer
- Subjects with Diabetes Mellitus treated with insulin and/or not controlled
- Subjects with kidney, heart, respiratory or liver disease.
- Subjects with autoimmune diseases.
- Subjects with mental illness or decrease function cognitive.
- Subjects who consume oral supplements or artificial nutrition and who cannot be withdran at least 1 week before startint the study.
- Patients who have consumed food supplements or fortified foods in omega 3 (arginine or nucleotides) during the previous month.
- Patients who reject oral supplements.
- Pregnant or breastfeeding women.
- Allergic to any component of the formula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial With Nutritional Intervention to Evaluate the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Patients With Cancer and Malnutrition
Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition
Read the detailed description
Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 8 weeks of duration and 2 study groups of treatment: Experimental group (experimental nutritional oral supplement); and Control group (control nutritional oral supplement) to evaluate the effect on the nutritional and functional status, the quality of life and body composition of patients with cancer and malnutrition undergoint specficic treatment (chemotherapy, radiotherapy, inmunotherapy).
- Conditions
- Malnutrition, Cancer, Nutrition Related Cancer
- Being tested
- Experimental Group, Control Group
- Keywords
- malnutrition, cancer, nutrition, nutritional oral supplement, clinical trial
- Medical subject headings
- Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupDietary supplement
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber and omega-3 enriched, with L-leucine, betaglucans and medium chain triglycerides) for 8 weeks.
Control GroupDietary supplement
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement Receives: Dietary Supplement: Experimental Group |
| Control group | Active comparator | Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement Receives: Dietary Supplement: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Subjective Global Assessment (SGA)
Measured: Change from baseline to day 142
Secondary outcomes (4)
Diet quality
72h food registry questionaire
Measured: Change from baseline to day 142
Functional status
Dinamometer
Measured: Change from baseline to day 142
Eastern Cooperative Oncology Group Scale (ECOG)
Eastern Cooperative Oncology Group Scale (ECOG)
Measured: Change from baseline to day 142
Body composition
BIA
Measured: Change from baseline to day 142
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Oct 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Adventia Pharma
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, Msc, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184713
- Sponsor's protocol ID
- HULP 5358
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial With Nutritional Intervention to Evaluate the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Patients With Cancer and Malnutrition
- ClinicalTrials.gov ID
- NCT04184713
- Acronym / sponsor ID
- HULP 5358
- Conditions
- Malnutrition, Cancer, Nutrition Related Cancer
- Keywords
- malnutrition, cancer, nutrition, nutritional oral supplement, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Adventia Pharma
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 4 Dec 2019 (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.
Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition
Detailed description
Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 8 weeks of duration and 2 study groups of treatment: Experimental group (experimental nutritional oral supplement); and Control group (control nutritional oral supplement) to evaluate the effect on the nutritional and functional status, the quality of life and body composition of patients with cancer and malnutrition undergoint specficic treatment (chemotherapy, radiotherapy, inmunotherapy).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Experimental GroupNutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement |
| Control group | Active comparator | Dietary Supplement: Control GroupNutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement |
Who may qualify
- Ages
- 28 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women over 18 with a cancer diagnosis (any type).
- Subjects who have initiated during the next mont a treatment with chemo and or radiotherapy with or without surgery.
- Having lost more than 5% of body weight in the last 6 months.
- Adequate cultural level and understanding for the clinical trial.
- Signed informed consent.
Key exclusion criteria (15 listed)
- Subjects who are participating in other clinical trials.
- Subjects with morbid obesity.
- Subjects who will undergo surgery or who will undergo.
- Subjects with cachexia
- Subjects with infection of a cause other than of the tumor
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 |
|---|---|---|
| Experimental GroupNutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber and omega-3 enriched, with L-leucine, betaglucans and medium chain triglycerides) for 8 weeks. | Dietary supplement | Experimental Group |
| Control GroupNutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber) for 8 weeks. | Dietary supplement | Control group |
Primary outcome
Nutritional status
Time frame: Change from baseline to day 142
Subjective Global Assessment (SGA)
4 secondary outcomes
Diet quality
Time frame: Change from baseline to day 142
Functional status
Time frame: Change from baseline to day 142
Eastern Cooperative Oncology Group Scale (ECOG)
Time frame: Change from baseline to day 142
Body composition
Time frame: Change from baseline to day 142
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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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.
Carmen Gómez Candela, Msc principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Malnutrition and Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 15 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: finished, as of the sponsor's last update on 20 Jul 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nutritional status (time frame: Change from baseline to day 142). 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 20 Jul 2021.