SarcopeniaNCT05837741
Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia
A study testing Standard hypercaloric hyperproteic oral nutritional supplement and Leucine-enriched hypercaloric hyperproteic oral nutritional supplement in people with Sarcopenia and Cancer, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcopenia, Cancer
- What is being tested?
- Standard hypercaloric hyperproteic oral nutritional supplement and Leucine-enriched hypercaloric hyperproteic oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 1 Nov 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of both sexes, age > 18 y-old
- cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t
- weight loss >5% during the previous three months or >10% during the previous six months
Who cannot join
- end-stage kidney disease
- life expectancy < 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard Hypercaloric, Hyperproteic vs Leucine-enriched Oral Supplements in Patients With Cancer-induced Sarcopenia
Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements.
Read the detailed description
Appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required
- Conditions
- Sarcopenia, Cancer
- Being tested
- Standard hypercaloric hyperproteic oral nutritional supplement, Leucine-enriched hypercaloric hyperproteic oral nutritional supplement
- Keywords
- Sarcopenia, Cancer
- Medical subject headings
- Sarcopenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard hypercaloric hyperproteic oral nutritional supplementDietary supplement
Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement
Leucine-enriched hypercaloric hyperproteic oral nutritional supplementDietary supplement
Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| Standard hypercaloric, hyperproteic oral supplement | Active comparator | Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement) Receives: Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement |
| Leucin-enriched hypercaloric, hyperproteic oral supplement | Active comparator | Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement) Receives: Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass gain
Changes in Muscle mass (%) determined by BIA and echography
Measured: 3 Months
Secondary outcomes (5)
Fat mass change
Changes in fast mass (%) determined by BIA and echography
Measured: 3 Months
Phase angle change
Changes in phase angle determined by BIA
Measured: 3 Months
Changes in albumin
Changes in serum albumin levels (g/dL)
Measured: 3 Months
Changes in prealbumin
Changes in serum prealbumin levels (mg/dL)
Measured: 3 Months
Changes in CRP
Changes in serum CRP levels (g/L)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Mar 2021
- Primary completion1 Aug 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aura Herrera, Maimónides Biomedical Research Institute of Córdoba
- Investigators
- Aura D Herrera Martinez, PhD, Principal investigator, IMIBIC-HURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837741
- Sponsor's protocol ID
- Sarcopenia-Leucina1
- Status last verified
- May 2023
- First submitted
- 1 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Hypercaloric, Hyperproteic vs Leucine-enriched Oral Supplements in Patients With Cancer-induced Sarcopenia
- ClinicalTrials.gov ID
- NCT05837741
- Acronym / sponsor ID
- Sarcopenia-Leucina1
- Conditions
- Sarcopenia, Cancer
- Keywords
- Sarcopenia, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 1 May 2023 (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.
Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements.
Detailed description
Appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard hypercaloric, hyperproteic oral supplement | Active comparator | Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplementPatients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement) |
| Leucin-enriched hypercaloric, hyperproteic oral supplement | Active comparator | Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplementPatients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients of both sexes, age > 18 y-old
- cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t
- weight loss >5% during the previous three months or >10% during the previous six months
Key exclusion criteria (2 listed)
- end-stage kidney disease
- life expectancy < 2 weeks
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 |
|---|---|---|
| Standard hypercaloric hyperproteic oral nutritional supplementPatients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement | Dietary supplement | Standard hypercaloric, hyperproteic oral supplement |
| Leucine-enriched hypercaloric hyperproteic oral nutritional supplementPatients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement | Dietary supplement | Leucin-enriched hypercaloric, hyperproteic oral supplement |
Primary outcome
Muscle mass gain
Time frame: 3 Months
Changes in Muscle mass (%) determined by BIA and echography
5 secondary outcomes
Fat mass change
Time frame: 3 Months
Phase angle change
Time frame: 3 Months
Changes in albumin
Time frame: 3 Months
Changes in prealbumin
Time frame: 3 Months
Changes in CRP
Time frame: 3 Months
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 9 May 2023.
- 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.
Aura D Herrera Martinez, PhD principal investigator
IMIBIC-HURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard hypercaloric hyperproteic oral nutritional supplement and Leucine-enriched hypercaloric hyperproteic oral nutritional supplement in people with Sarcopenia and Cancer, run by Maimónides Biomedical Research Institute of Córdoba 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 3 inclusion and 2 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 9 May 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 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?
Muscle mass gain (time frame: 3 Months). 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 9 May 2023.