UndernutritionMETERMUCADIGNCT02573974
Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
A study testing Samples in people with Undernutrition and Gastrointestinal Cancer, run by University Hospital, Tours at 1 site in France.
Trial summary
Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Undernutrition, Gastrointestinal Cancer
- What is being tested?
- Samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2016to 4 Dec 2018
- 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
- 18 years ≤ Age ≤ 80 years
- Colorectal pancreatic cancer
- Undernutrition related to cancer (weight loss > 5% weight in one month or 10% in 6 months)
- Indication to systemic chemotherapy
- Indication to the development of an implantable port
- Life expectancy ≥ 3 months
Show all 17Show fewer
- WHO General Status ≤ 2
- Patients affiliated to social security scheme
- Informed consent signed by the patient
- 18 years ≤ Age ≤ 80 years
- Colorectal pancreatic cancer
- Indication adjuvant chemotherapy
- Indication to the development of an implantable port
- Life expectancy ≥ 3 months
- WHO General Status ≤ 2
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Who cannot join
- Pregnant or breastfeeding women
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Any severe uncontrolled medical condition
- Alopecia
- Control group selection criteria:
Show all 12Show fewer
- Pregnant or breastfeeding women
- Undernutrition related cancer (weight loss > 5% weight in one month or 10% in 6 months)
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Any severe uncontrolled medical condition
- Alopecia
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS
Tours, 37044
About this study
Official title: Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or not explored, which could explain that there is still no satisfactory therapeutic solution to halt the gradual deterioration of the nutritional status of patients. In this sense, apart from preclinical data obtained in animal models, there is currently no clinical study on the functioning of skeletal muscle energy metabolism in undernourished patients suffering of cancer.
- Conditions
- Undernutrition, Gastrointestinal Cancer
- Being tested
- Samples
- Keywords
- undernutrition, gastrointestinal cancer, skeletal muscle, energy metabolism
- Medical subject headings
- Malnutrition, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesOther
Blood samples, muscle biopsy and sample of hair
| Study group | Role | What they receive |
|---|---|---|
| Case group | Other | the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer Receives: Other: Samples |
| Control group | Other | the intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer Receives: Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of muscle mitochondrial bioenergetics
Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy
Measured: An average of one week
Secondary outcomes (4)
Quantification of muscle lipid droplets
Quantification of muscle lipid droplets by electron microscopy
Measured: An average of one week
Analysis of the expression of target genes and proteins
Analysis of the expression of target genes and proteins involved in 1/ mitochondrial metabolism 2/ lipid metabolism 3/ the regulation of energy metabolism and 4/ muscle proteolysis by RTqPCR with SYBR Green and by Western Blot
Measured: An average of one week
Determination of body composition (fat mass / lean mass)
Determination of body composition ( fat mass / lean mass ) by an imaging method scannographic
Measured: Within 4 weeks before inclusion
Determining the isotopic composition of nitrogen hair
Determining the isotopic composition of nitrogen hair spectrometry .
Measured: An average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start19 Jan 2016
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Inserm U1069 - Team Nutrition, Growth and Cancer
- Responsible party
- Sponsor
- Investigators
- Thierry LECOMTE, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573974
- Sponsor's protocol ID
- PHAO14-TL/METERMUCADIG
- Other IDs
- 2015-A00683-46, 2015-R25, 150963B-12
- Acronym
- METERMUCADIG
- Status last verified
- Dec 2025
- First submitted
- 7 Oct 2015
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dolly A, Lecomte T, Tabchouri N, Caulet M, Michot N, Anon B, Chautard R, Desvignes Y, Ouaissi M, Fromont-Hankard G, Dumas JF, Servais S. Pectoralis major muscle atrophy is associated with mitochondrial energy wasting in cachectic patients with gastrointestinal cancer. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1837-1849. doi: 10.1002/jcsm.12984. Epub 2022 Mar 22.
PubMed 35316572
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT02573974
- Acronym / sponsor ID
- METERMUCADIG / PHAO14-TL/METERMUCADIG
- Conditions
- Undernutrition, Gastrointestinal Cancer
- Keywords
- undernutrition, gastrointestinal cancer, skeletal muscle, energy metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Inserm U1069 - Team Nutrition, Growth and Cancer
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 12 Oct 2015 (estimated)
- 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.
Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or not explored, which could explain that there is still no satisfactory therapeutic solution to halt the gradual deterioration of the nutritional status of patients. In this sense, apart from preclinical data obtained in animal models, there is currently no clinical study on the functioning of skeletal muscle energy metabolism in undernourished patients suffering of cancer.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Other | Other: Samplesthe intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer |
| Control group | Other | Other: Samplesthe intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 18 years ≤ Age ≤ 80 years
- Colorectal pancreatic cancer
- Undernutrition related to cancer (weight loss > 5% weight in one month or 10% in 6 months)
- Indication to systemic chemotherapy
- Indication to the development of an implantable port
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding women
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Any severe uncontrolled medical condition
- Alopecia
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 |
|---|---|---|
| SamplesBlood samples, muscle biopsy and sample of hair | Other | Case group, Control group |
Primary outcome
Measurement of muscle mitochondrial bioenergetics
Time frame: An average of one week
Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy
4 secondary outcomes
Quantification of muscle lipid droplets
Time frame: An average of one week
Analysis of the expression of target genes and proteins
Time frame: An average of one week
Determination of body composition (fat mass / lean mass)
Time frame: Within 4 weeks before inclusion
Determining the isotopic composition of nitrogen hair
Time frame: An average of one week
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 22 Dec 2025.
- Results publication: PubMed 35316572Dolly A, Lecomte T, Tabchouri N, Caulet M, Michot N, Anon B, Chautard R, Desvignes Y, Ouaissi M, Fromont-Hankard G, Dumas JF, Servais S. Pectoralis major muscle atrophy is associated with mitochondrial energy wasting in cachectic patients with gastrointestinal cancer. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1837-1849. doi: 10.1002/jcsm.12984. Epub 2022 Mar 22.
- 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.
Thierry LECOMTE, MD-PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samples in people with Undernutrition and Gastrointestinal Cancer, run by University Hospital, Tours at 1 site in France.
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 17 inclusion and 12 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 22 Dec 2025. 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 France. 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?
Measurement of muscle mitochondrial bioenergetics (time frame: An average of one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02573974, which also lists 1 linked publication.
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 22 Dec 2025.