CachexiaMYOCACHNCT03162042
Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers
An observational study of Cachexia and Squamous Cell Carcinoma, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The main objective of our study was to determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers. Secondary objectives consisted in studying their influence on the occurrence of cachexia, bringing the proof of a tumoral secretion of these factors, and then… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cachexia, Squamous Cell Carcinoma, Head and Neck Cancer
- What is being tested?
- Tumor removal
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2015to May 2017
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group.
Who may be able to join
- For case group :
- head and neck cancer
- squamous cell carinoma only
- head and neck surgery chosen as treatment of cancer
- age 18-75
- For control group :
- Neck surgery for non oncologic disease
- age 18-75
Who cannot join
- heart failure, respiratory failure (requiring a long-term oxygen therapy), chronic renal failure (MDRD clearance < 60 ml/min), moderate or severe chronic obstructive pulmonary disease and insulin-dependent diabeta for the two groups
- cachexia for control group
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of our study was to determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers. Secondary objectives consisted in studying their influence on the occurrence of cachexia, bringing the proof of a tumoral secretion of these factors, and then determining the effect of tumor removal.
Read the detailed description
Myostatin and activin A, two members of the superfamily TGF-β, have been shown to play a role on skeletal muscle mass regulation. In Humans, high plasma concentrations of activin A were observed in cancer patients, especially in cachectic subpopulations, suggesting their involvement in the development of cachexia.
55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group. The patients underwent a complete nutritional assessment and multiple samples : blood before and 7 days after surgery, skeletal muscle biopsies, tumor biopsies. Plasma concentrations of myostatin, activin and follistatin were measured before and after tumor removal surgery. Concentrations of myostatin, activin and follistatin were also measured in an incubation medium of a tumor biopsy. Activin A and follistatin plasma concentrations were significantly increased in the cancer group (320 vs. 203 pg/ml ; p <0.001) (3593 vs 2148 pg/ml ; p <0.001), while myostatin plasma concentration was significantly decreased in this group (1542 vs. 2100 pg/ml ; p = 0.010). Surprisingly, data of the 7th postoperative day showed an increase in plasma activin A concentration (379 vs 320 pg /ml ; p <0.001) while concentrations of myostatin and follistatin were not modified. A high postoperative systemic inflammation is one hypothesis to explain these later results. Myostatin, activin A and follistatin proteins were systematically detected in the medium of tumor a 48 hour-incubation period, providing a strong proof of the tumor production of these factors by squamous cell carcinoma. The activin A/myostatin/follistatin is modified in the context of head and neck cancer. Activin A particularly seems to play a role in the occurrence of cachexia while follistatin could have a protective role for skeletal muscle mass. This system could aimed in therapeutic ways to reduce cachexia in a context of cancer in order to improve the quality of life and survival of patients.
- Conditions
- Cachexia, Squamous Cell Carcinoma, Head and Neck Cancer
- Being tested
- Tumor removal
- Keywords
- Activin A, Myostatin, Follistatin, Cachexia, Squamous cell carcinoma
- Medical subject headings
- Cachexia, Carcinoma, Squamous Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor removalProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| Squamous cell carcinoma | 55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group. Receives: Procedure: Tumor removal | |
| Control group | 55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group. Receives: Procedure: Tumor removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of plasma activin A (pg/ml)
determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers
Measured: at day 1
Measure of plasma follistation (pg/ml)
determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers
Measured: at day 1
Measure of plasma myostatin (pg/ml)
determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers
Measured: at day 1
Secondary outcomes (1)
Influence on the occurrence of cachexia
Bringing the proof of a tumoral secretion of these factors, and then determining the effect of tumor removal.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start2 Nov 2015
- Primary completionFeb 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162042
- Sponsor's protocol ID
- CHU-326
- Other IDs
- 2015-A00833-46
- Acronym
- MYOCACH
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 22 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers
- ClinicalTrials.gov ID
- NCT03162042
- Acronym / sponsor ID
- MYOCACH / CHU-326
- Conditions
- Cachexia, Squamous Cell Carcinoma, Head and Neck Cancer
- Keywords
- Activin A, Myostatin, Follistatin, Cachexia, Squamous cell carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 22 May 2017 (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.
The main objective of our study was to determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers. Secondary objectives consisted in studying their influence on the occurrence of cachexia, bringing the proof of a tumoral secretion of these factors, and then determining the effect of tumor removal.
Detailed description
Myostatin and activin A, two members of the superfamily TGF-β, have been shown to play a role on skeletal muscle mass regulation. In Humans, high plasma concentrations of activin A were observed in cancer patients, especially in cachectic subpopulations, suggesting their involvement in the development of cachexia.
55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group. The patients underwent a complete nutritional assessment and multiple samples : blood before and 7 days after surgery, skeletal muscle biopsies, tumor biopsies. Plasma concentrations of myostatin, activin and follistatin were measured before and after tumor removal surgery. Concentrations of myostatin, activin and follistatin were also measured in an incubation medium of a tumor biopsy. Activin A and follistatin plasma concentrations were significantly increased in the cancer group (320 vs. 203 pg/ml ; p <0.001) (3593 vs 2148 pg/ml ; p <0.001), while myostatin plasma concentration was significantly decreased in this group (1542 vs. 2100 pg/ml ; p = 0.010). Surprisingly, data of the 7th postoperative day showed an increase in plasma activin A concentration (379 vs 320 pg /ml ; p <0.001) while concentrations of myostatin and follistatin were not modified. A high postoperative systemic inflammation is one hypothesis to explain these later results. Myostatin, activin A and follistatin proteins were systematically detected in the medium of tumor a 48 hour-incubation period, providing a strong proof of the tumor production of these factors by squamous cell carcinoma. The activin A/myostatin/follistatin is modified in the context of head and neck cancer. Activin A particularly seems to play a role in the occurrence of cachexia while follistatin could have a protective role for skeletal muscle mass. This system could aimed in therapeutic ways to reduce cachexia in a context of cancer in order to improve the quality of life and survival of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Squamous cell carcinoma | – | Procedure: Tumor removal55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group. |
| Control group | – | Procedure: Tumor removal55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group.
Key inclusion criteria (8 listed)
- head and neck cancer
- squamous cell carinoma only
- head and neck surgery chosen as treatment of cancer
- age 18-75
- Neck surgery for non oncologic disease
Key exclusion criteria (2 listed)
- heart failure, respiratory failure (requiring a long-term oxygen therapy), chronic renal failure (MDRD clearance < 60 ml/min), moderate or severe chronic obstructive pulmonary disease and insulin-dependent diabeta for the two groups
- cachexia for control group
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 |
|---|---|---|
| Tumor removalSurgery | Procedure or surgery | Control group, Squamous cell carcinoma |
Primary outcome
Measure of plasma activin A (pg/ml)
Time frame: at day 1
determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers
Measure of plasma follistation (pg/ml)
Time frame: at day 1
determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers
Measure of plasma myostatin (pg/ml)
Time frame: at day 1
determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers
1 secondary outcome
Influence on the occurrence of cachexia
Time frame: at day 1
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 May 2017.
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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?
An observational study of Cachexia and Squamous Cell Carcinoma, run by University Hospital, Clermont-Ferrand 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 8 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 22 May 2017. 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?
Measure of plasma activin A (pg/ml) (time frame: at day 1). The study lists 3 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 22 May 2017.