CachexiaMExNCT05028192
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
An observational study of Cachexia and Rectal Cancer, run by University of Turin, Italy at 1 site in Italy.
Trial summary
This study aims to define the contribution of cancer and chemotherapy to muscle and systemic alterations that drive the onset of cachexia in rectal cancer patients and validate in human cancer cachexia (CC) the alterations in mitochondrial function and neuromuscular junction (NMJ) observed in the experimental models… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cachexia, Rectal Cancer
- Type of treatment
- Injection or infusion
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2021to 1 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients from all participating centers older than 18 years, males or females, with the primary diagnosis of rectal cancer ycTNM stage II, III or IV (American Joint Committee on Cancer 8th edition), who undergone neoadjuvant therapy. Clinically stratified in the pre-cachectic or cachectic stage according to Fearon K et al. definition. That will be subject to low or ultralow anterior resection, abdominoperineal resection or palliative surgery through any approach (open, laparoscopic or robotic).
Who may be able to join
- Patients with confirmed histopathological diagnosis of rectal adenocarcinoma ycTNM stage II, III, or IV (AJCC 8th).
- Patients treated with neoadjuvant therapy.
- Patients that will be subject to curative intent or palliative surgery through any approach (open, laparoscopic, or robotic).
- Ability to sign the informed consent.
Who cannot join
- Rectal cancer stage I or any stage without neoadjuvant therapy.
- Age < 18 and >75 years
- Long steroid treatment for any cause.
- Emergency setting.
- Co-existent inflammatory bowel disease.
- Inflammatory comorbidities (liver failure, diabetes, metabolic acidosis, acute and chronic renal failure, sepsis, AIDS, acute and chronic hepatitis, autoimmune disorders, and chronic obstructive pulmonary disease).
- Healthy volunteers.
- Other (simultaneous) neoplastic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitochondria Preservation by Exercise Training: A Targeted Therapy for Cancer and Chemotherapy-induced Cachexia.
This study aims to define the contribution of cancer and chemotherapy to muscle and systemic alterations that drive the onset of cachexia in rectal cancer patients and validate in human cancer cachexia (CC) the alterations in mitochondrial function and neuromuscular junction (NMJ) observed in the experimental models, thus providing the rationale for potential anti-cachexia strategies based on exercise and or exercise mimetics.
Read the detailed description
This is a multicenter observational prospective cohort study in rectal cancer patients after neoadjuvant therapy (ycTNM) stage II, III, and IV (AJCC 8th edit), clinically stratified in the pre-cachectic or cachectic stage according to Fearon K et al. definition. That will be subject to curative or palliative surgery through any surgical approach. And a control subgroup of patients who will undergo any abdominal surgery type through any approach type for no neoplastic or inflammatory disease.
The study will take place in four Italian centers of colorectal surgery.
Will be run a preoperatory physical performance, and will be recorded the physical activity by wearing a SmartWatch.
The quantity of muscle will be estimated by the cross-sectional area (CSA) or the skeletal muscle area (SMA) from the magnetic resonance imaging (MRI) or computed tomography CT, respectively, and the Skeletal muscle index (SMI). The muscular quality will be studied by the mean skeletal muscle radiation attenuation (SMRA) and MRI proton density fat fraction (PDFF). All these parameters will be calculated by a radiologist from the preoperative MRI or CT imaging study.
The study includes the analysis of preoperatory inflammatory and nutritional biomarkers. And a muscular biopsy harvested by the surgeon from the rectum or oblique abdominal during rectal resection-palliative surgery. The sample will undergo morphological and structural studies using histology, immunohistochemical, immunofluorescence, biochemical, and molecular analyses.
- Conditions
- Cachexia, Rectal Cancer
- Being tested
- no intervention
- Medical subject headings
- Cachexia, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer after neoadjuvant treatment | Rectal cancer patients, ycTNM stage II, III, and IV (AJCC 8th), clinically stratified in the pre-cachectic or cachectic stage according to Fearon K et al. definition. That will be subject to curative intent resection or palliative surgery through any approach (open, laparoscopic, or robotic). Receives: Other: no intervention | |
| Control group | Patients who will undergo programmed abdominal surgery through any approach type for no neoplastic or inflammatory disease. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Determinate by the short physical performance battery (SPPB) Score, a series of tests used to evaluate lower extremity function and mobility in older people. Scores are assigned according to performance, with an overall maximum score of 12. A cut off score < 10 indicates mobility disability and cut point: ≤ 8 points for diagnosing of severe sarcopenia
Measured: Preoperative.
Physical activity-Subjective Measurement
Determinate by the physical activity scale for the elderly (PASE) Score, the overall score ranging from 0 to 793, higher scores indicated greater physical activity
Measured: Preoperative
Physical activity-Objective Measurement (step count)
Determinate by the average daily step count (total number of steps/14 days) recorded by wearing a Smart Watch for two weeks on consecutive days.
Measured: Preoperative.
Physical activity-Objective Measurement (sleep)
Determinate by the average of daily sleep duration(total minutes of sleep/ 14 days) recorded by wearing a Smart Watch for two weeks on consecutive days.
Measured: Preoperative.
Physical activity-Objective Measurement (sedentary time)
Determinate by the average daily sedentary time (total minutes of inactivity/14 days) recorded by wearing a Smart Watch for two weeks on consecutive days.
Measured: Preoperative.
Physical activity-Objective Measurement (active time)
Determinate by the average daily active time (total duration of activity in minutes/14 days) recorded by wearing a Smart Watch for two weeks on consecutive days.
Measured: Preoperative.
Muscular quantity
Determinate by the Skeletal muscle index (SMI) = skeletal muscle area or cross-sectional area at L4-L5 (cm2)/height2(m2) from the preoperative magnetic resonance imaging.
Measured: Preoperative.
Muscular quality (muscle fat content) by magnetic resonance imaging
Determinate by the proton density fat fraction (PDFF) of paraspinal muscles at L4-L5
Measured: Preoperative.
Nutritional status - Albumin
Blood levels of albumin (g/dL).
Measured: Preoperative.
Nutritional status - Prealbumin
Blood levels of prealbumin(mg/dL).
Measured: Preoperative.
Nutritional status - transferrin
Blood levels of transferrin(mg/dL).
Measured: Preoperative.
General health marker- hemoglobin
Blood levels of Hemoglobin (g/L).
Measured: Preoperative.
Inflammatory status-White blood cells count
White blood cells count (10^/L).
Measured: Preoperative.
Inflammatory status - C-reactive protein
Blood levels of C-reactive protein (mg/dL).
Measured: Preoperative.
Muscle wasting- creatine kinase
Blood levels of creatine kinase (U/L).
Measured: Preoperative.
Morphometric analysis of skeletal muscle
Description of the dimension and type of muscular fibers from an abdominal wall muscle biopsy harvested intraoperatively.
Measured: within 30 postoperative days.
Molecular analysis of skeletal muscle
Characterization of molecular signatures associated with Neo-adjuvant Chemotherapy and rectal cancer by comparing molecular profiles of a muscular biopsies harvested intraoperatively.
Measured: within 60 postoperative days.
Muscle protein metabolism
Muscle-specific ubiquitin-ligases expression, mitophagy cargo shuttle, fusion-fission machinery, and mitochondrial biogenesis will be assayed from a muscular biopsy harvested intraoperatively.
Measured: within 60 postoperative days.
Secondary outcomes (1)
Overall survival
to describe the percentage of participants who are alive three years after surgery
Measured: 3 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start27 Sep 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova, Catholic University of the Sacred Heart, University of Roma La Sapienza
- Responsible party
- Sponsor
- Investigators
- Maurizio Degiuli, Prof., Study chair, Università degli studi di Torino- Surgical Oncology and Digestive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028192
- Sponsor's protocol ID
- N. 98/2021
- Acronym
- MEx
- Status last verified
- Sep 2021
- First submitted
- 25 May 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dev R. Measuring cachexia-diagnostic criteria. Ann Palliat Med. 2019 Jan;8(1):24-32. doi: 10.21037/apm.2018.08.07. Epub 2018 Sep 7.
PubMed 30525765Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
PubMed 21296615Freire PP, Fernandez GJ, Cury SS, de Moraes D, Oliveira JS, de Oliveira G, Dal-Pai-Silva M, Dos Reis PP, Carvalho RF. The Pathway to Cancer Cachexia: MicroRNA-Regulated Networks in Muscle Wasting Based on Integrative Meta-Analysis. Int J Mol Sci. 2019 Apr 22;20(8):1962. doi: 10.3390/ijms20081962.
PubMed 31013615Baracos VE. Skeletal muscle anabolism in patients with advanced cancer. Lancet Oncol. 2015 Jan;16(1):13-4. doi: 10.1016/S1470-2045(14)71185-4. Epub 2014 Dec 16. No abstract available.
PubMed 25524803Wiegert EVM, de Oliveira LC, Calixto-Lima L, Borges NA, Rodrigues J, da Mota E Silva Lopes MS, Peres WAF. Association between low muscle mass and survival in incurable cancer patients: A systematic review. Nutrition. 2020 Apr;72:110695. doi: 10.1016/j.nut.2019.110695. Epub 2019 Dec 7.
PubMed 32007806Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
PubMed 31081853Penet MF, Bhujwalla ZM. Cancer cachexia, recent advances, and future directions. Cancer J. 2015 Mar-Apr;21(2):117-22. doi: 10.1097/PPO.0000000000000100.
PubMed 25815852Codari M, Zanardo M, di Sabato ME, Nocerino E, Messina C, Sconfienza LM, Sardanelli F. MRI-Derived Biomarkers Related to Sarcopenia: A Systematic Review. J Magn Reson Imaging. 2020 Apr;51(4):1117-1127. doi: 10.1002/jmri.26931. Epub 2019 Sep 13.
PubMed 31515891
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondria Preservation by Exercise Training: A Targeted Therapy for Cancer and Chemotherapy-induced Cachexia.
- ClinicalTrials.gov ID
- NCT05028192
- Acronym / sponsor ID
- MEx / N. 98/2021
- Conditions
- Cachexia, Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- University of Padova, Catholic University of the Sacred Heart, University of Roma La Sapienza
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 31 Aug 2021 (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 aims to define the contribution of cancer and chemotherapy to muscle and systemic alterations that drive the onset of cachexia in rectal cancer patients and validate in human cancer cachexia (CC) the alterations in mitochondrial function and neuromuscular junction (NMJ) observed in the experimental models, thus providing the rationale for potential anti-cachexia strategies based on exercise and or exercise mimetics.
Detailed description
This is a multicenter observational prospective cohort study in rectal cancer patients after neoadjuvant therapy (ycTNM) stage II, III, and IV (AJCC 8th edit), clinically stratified in the pre-cachectic or cachectic stage according to Fearon K et al. definition. That will be subject to curative or palliative surgery through any surgical approach. And a control subgroup of patients who will undergo any abdominal surgery type through any approach type for no neoplastic or inflammatory disease.
The study will take place in four Italian centers of colorectal surgery.
Will be run a preoperatory physical performance, and will be recorded the physical activity by wearing a SmartWatch.
The quantity of muscle will be estimated by the cross-sectional area (CSA) or the skeletal muscle area (SMA) from the magnetic resonance imaging (MRI) or computed tomography CT, respectively, and the Skeletal muscle index (SMI). The muscular quality will be studied by the mean skeletal muscle radiation attenuation (SMRA) and MRI proton density fat fraction (PDFF). All these parameters will be calculated by a radiologist from the preoperative MRI or CT imaging study.
The study includes the analysis of preoperatory inflammatory and nutritional biomarkers. And a muscular biopsy harvested by the surgeon from the rectum or oblique abdominal during rectal resection-palliative surgery. The sample will undergo morphological and structural studies using histology, immunohistochemical, immunofluorescence, biochemical, and molecular analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer after neoadjuvant treatment | – | Other: no interventionRectal cancer patients, ycTNM stage II, III, and IV (AJCC 8th), clinically stratified in the pre-cachectic or cachectic stage according to Fearon K et al. definition. That will be subject to curative intent resection or palliative surgery through any approach (open, laparoscopic, or robotic). |
| Control group | – | Other: no interventionPatients who will undergo programmed abdominal surgery through any approach type for no neoplastic or inflammatory disease. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from all participating centers older than 18 years, males or females, with the primary diagnosis of rectal cancer ycTNM stage II, III or IV (American Joint Committee on Cancer 8th edition), who undergone neoadjuvant therapy. Clinically stratified in the pre-cachectic or cachectic stage according to Fearon K et al. definition. That will be subject to low or ultralow anterior resection, abdominoperineal resection or palliative surgery through any approach (open, laparoscopic or robotic).
Key inclusion criteria (4 listed)
- Patients with confirmed histopathological diagnosis of rectal adenocarcinoma ycTNM stage II, III, or IV (AJCC 8th).
- Patients treated with neoadjuvant therapy.
- Patients that will be subject to curative intent or palliative surgery through any approach (open, laparoscopic, or robotic).
- Ability to sign the informed consent.
Key exclusion criteria (8 listed)
- Rectal cancer stage I or any stage without neoadjuvant therapy.
- Age < 18 and >75 years
- Long steroid treatment for any cause.
- Emergency setting.
- Co-existent inflammatory bowel disease.
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 |
|---|---|---|
| no interventionno intervention | Other | Control group, Rectal cancer after neoadjuvant treatment |
Primary outcome
Physical function
Time frame: Preoperative.
Determinate by the short physical performance battery (SPPB) Score, a series of tests used to evaluate lower extremity function and mobility in older people. Scores are assigned according to performance, with an overall maximum score of 12. A cut off score < 10 indicates mobility disability and cut point: ≤ 8 points for diagnosing of severe sarcopenia
Physical activity-Subjective Measurement
Time frame: Preoperative
Determinate by the physical activity scale for the elderly (PASE) Score, the overall score ranging from 0 to 793, higher scores indicated greater physical activity
Physical activity-Objective Measurement (step count)
Time frame: Preoperative.
Determinate by the average daily step count (total number of steps/14 days) recorded by wearing a Smart Watch for two weeks on consecutive days.
Physical activity-Objective Measurement (sleep)
Time frame: Preoperative.
Determinate by the average of daily sleep duration(total minutes of sleep/ 14 days) recorded by wearing a Smart Watch for two weeks on consecutive days.
Physical activity-Objective Measurement (sedentary time)
Time frame: Preoperative.
Determinate by the average daily sedentary time (total minutes of inactivity/14 days) recorded by wearing a Smart Watch for two weeks on consecutive days.
Physical activity-Objective Measurement (active time)
Time frame: Preoperative.
Determinate by the average daily active time (total duration of activity in minutes/14 days) recorded by wearing a Smart Watch for two weeks on consecutive days.
Muscular quantity
Time frame: Preoperative.
Determinate by the Skeletal muscle index (SMI) = skeletal muscle area or cross-sectional area at L4-L5 (cm2)/height2(m2) from the preoperative magnetic resonance imaging.
Muscular quality (muscle fat content) by magnetic resonance imaging
Time frame: Preoperative.
Determinate by the proton density fat fraction (PDFF) of paraspinal muscles at L4-L5
Nutritional status - Albumin
Time frame: Preoperative.
Blood levels of albumin (g/dL).
Nutritional status - Prealbumin
Time frame: Preoperative.
Blood levels of prealbumin(mg/dL).
Nutritional status - transferrin
Time frame: Preoperative.
Blood levels of transferrin(mg/dL).
General health marker- hemoglobin
Time frame: Preoperative.
Blood levels of Hemoglobin (g/L).
Inflammatory status-White blood cells count
Time frame: Preoperative.
White blood cells count (10^/L).
Inflammatory status - C-reactive protein
Time frame: Preoperative.
Blood levels of C-reactive protein (mg/dL).
Muscle wasting- creatine kinase
Time frame: Preoperative.
Blood levels of creatine kinase (U/L).
Morphometric analysis of skeletal muscle
Time frame: within 30 postoperative days.
Description of the dimension and type of muscular fibers from an abdominal wall muscle biopsy harvested intraoperatively.
Molecular analysis of skeletal muscle
Time frame: within 60 postoperative days.
Characterization of molecular signatures associated with Neo-adjuvant Chemotherapy and rectal cancer by comparing molecular profiles of a muscular biopsies harvested intraoperatively.
Muscle protein metabolism
Time frame: within 60 postoperative days.
Muscle-specific ubiquitin-ligases expression, mitophagy cargo shuttle, fusion-fission machinery, and mitochondrial biogenesis will be assayed from a muscular biopsy harvested intraoperatively.
1 secondary outcome
Overall survival
Time frame: 3 years after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 30525765Dev R. Measuring cachexia-diagnostic criteria. Ann Palliat Med. 2019 Jan;8(1):24-32. doi: 10.21037/apm.2018.08.07. Epub 2018 Sep 7.
- Background: PubMed 21296615Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
- Background: PubMed 31013615Freire PP, Fernandez GJ, Cury SS, de Moraes D, Oliveira JS, de Oliveira G, Dal-Pai-Silva M, Dos Reis PP, Carvalho RF. The Pathway to Cancer Cachexia: MicroRNA-Regulated Networks in Muscle Wasting Based on Integrative Meta-Analysis. Int J Mol Sci. 2019 Apr 22;20(8):1962. doi: 10.3390/ijms20081962.
- Background: PubMed 25524803Baracos VE. Skeletal muscle anabolism in patients with advanced cancer. Lancet Oncol. 2015 Jan;16(1):13-4. doi: 10.1016/S1470-2045(14)71185-4. Epub 2014 Dec 16. No abstract available.
- Background: PubMed 32007806Wiegert EVM, de Oliveira LC, Calixto-Lima L, Borges NA, Rodrigues J, da Mota E Silva Lopes MS, Peres WAF. Association between low muscle mass and survival in incurable cancer patients: A systematic review. Nutrition. 2020 Apr;72:110695. doi: 10.1016/j.nut.2019.110695. Epub 2019 Dec 7.
- Background: PubMed 31081853Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
- Background: PubMed 25815852Penet MF, Bhujwalla ZM. Cancer cachexia, recent advances, and future directions. Cancer J. 2015 Mar-Apr;21(2):117-22. doi: 10.1097/PPO.0000000000000100.
- Background: PubMed 31515891Codari M, Zanardo M, di Sabato ME, Nocerino E, Messina C, Sconfienza LM, Sardanelli F. MRI-Derived Biomarkers Related to Sarcopenia: A Systematic Review. J Magn Reson Imaging. 2020 Apr;51(4):1117-1127. doi: 10.1002/jmri.26931. Epub 2019 Sep 13.
- Individual participant dataSharing planned: Undecided
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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.
Maurizio Degiuli, Prof. study chair
Università degli studi di Torino- Surgical Oncology and Digestive Surgery
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 Rectal Cancer, run by University of Turin, Italy at 1 site in Italy.
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 4 inclusion and 8 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 29 Sep 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 Italy. 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?
Physical function (time frame: Preoperative.). The study lists 18 primary outcomes in all. 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 NCT05028192, which also lists 8 linked publications.
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 29 Sep 2021.