Cachexia; Cancer; SarcopeniaPRCC-MONCT07519837
Study on the Pathogenesis and Reversal Strategies of Cancer Cachexia Based on Multi-Omics
A study testing Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients in people with Cachexia; Cancer; Sarcopenia, run by China Medical University, China at 1 site in China.
Trial summary
Cancer cachexia is a complex systemic metabolic syndrome with high incidence and mortality rates, significantly impacting the prognosis and survival of cancer patients.Current clinical comprehensive intervention approaches can only provide transient symptom relief and fail to fundamentally block or reverse muscle and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia; Cancer; Sarcopenia
- What is being tested?
- Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2026to 20 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Signed informed consent form and voluntary participation in this study
- Histologically and/or cytologically confirmed diagnosis of cancer
- Patients with gastrointestinal malignancies, including:
- Esophageal cancer
- Hepatocellular carcinoma
Show all 9Show fewer
- Gastric cancer
- Cholangiocarcinoma
- Patients undergoing histopathological examination of primary lesion biopsy or gastrointestinal endoscopic biopsy
Who cannot join
- Pregnant or lactating women
- Presence of contraindications to surgery
- Cognitive dysfunction, psychiatric disorders, impaired consciousness, or inability/unwillingness to cooperate
- Presence of two or more concurrent primary tumors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
Kai Li, +86 18941960007, cmu_likai@163.com
About this study
Cancer cachexia is a complex systemic metabolic syndrome with high incidence and mortality rates, significantly impacting the prognosis and survival of cancer patients.Current clinical comprehensive intervention approaches can only provide transient symptom relief and fail to fundamentally block or reverse muscle and fat loss. The core challenge lies in the extreme complexity of this pathological mechanism and the lack of early biomarkers.To overcome the limitations of traditional single-dimensional research approaches, this study proposes a combined analysis method utilizing "multi-omics" (imaging omics, pathological omics, metabolomics, and metagenomics) to construct a panoramic systemic model spanning macroscopic clinical manifestations and microscopic molecular processes. The aim is to comprehensively elucidate the pathogenesis and metabolic pathways of cachexia, thereby precisely identifying potential therapeutic targets capable of reversing this pathological process.
Read the detailed description
Cancer cachexia is a multifactorial metabolic syndrome characterized by persistent skeletal muscle atrophy, with or without loss of adipose tissue. It differs from conventional malnutrition, for which conventional nutritional support often fails to fully reverse its progression. Cachexia has an extremely high incidence rate in patients with advanced cancer, with an overall prevalence ranging from approximately 50% to 80%. Especially in malignant tumors of the digestive system such as gastric cancer, colorectal cancer, and pancreatic cancer, the incidence of cachexia is higher due to direct involvement of digestive organs by tumors, and the disease prognosis is often more severe. Existing medical evidence indicates that cancer cachexia is closely associated with poor prognosis. Cachexia not only leads to a sharp decline in physical condition and impairment of quality of life, but also significantly reduces tolerance to chemotherapy, radiotherapy, and surgery, while increasing treatment-related toxic side effects. According to statistics, approximately 20% to 30% of cancer-related deaths are not directly attributable to increased tumor burden, but rather to cardiopulmonary failure and metabolic collapse caused by cachexia. Therefore, controlling and reversing cachexia is a critical step in prolonging survival and improving treatment outcomes.
At present, clinical treatment of cancer cachexia does not rely on a single approach but rather tends to adopt a "multimodal comprehensive intervention strategy." Specifically, this strategy encompasses enhanced nutritional support therapy (such as providing high-protein, high-calorie enteral/parenteral nutrition formulations), pharmacological interventions (including the use of progestogens to improve appetite and nonsteroidal anti-inflammatory drugs to counter systemic inflammatory responses), and targeted rehabilitation physical training, aiming to maintain functional status through a multidisciplinary approach. However, it must be acknowledged that despite the implementation of the aforementioned comprehensive measures, significant limitations in clinical efficacy remain. In clinical practice, these interventions often only provide temporary symptomatic relief to a limited extent (e.g., short-term improvement in appetite or slowing of weight loss rate), but fail to fundamentally block the "molecular switch" underlying skeletal muscle protein degradation, nor can these interventions effectively reverse already established muscle atrophy and functional decline. The fundamental reason for this dilemma lies in the extreme complexity of the pathogenesis of cachexia. Cachexia is not merely "malnutrition," but rather a "metabolic storm" involving abnormal regulation of multiple organs (muscle, adipose tissue, liver, intestine, etc.) and systems (immune, neuroendocrine, metabolic) throughout the body. Current treatments often only address downstream symptoms without correcting the complex upstream molecular dysregulation. More critically, there is currently an extreme lack of in-depth understanding of the early activation mechanisms of cachexia in clinical practice, and no reliable, high-sensitivity biomarkers (such as specific blood parameters or imaging features) are available. This results in the vast majority of patients being diagnosed with cachexia when the body is already in a severe catabolic state (resistant phase), thereby missing the optimal time window for early intervention and disease reversal.
Cancer cachexia is essentially a highly complex systemic metabolic disorder syndrome, with core pathology stemming from extensive and profound abnormal interactions between tumors and the host. These interactions are not confined to the tumor site but also trigger multi-organ functional remodeling, including skeletal muscle and adipose tissue, through inflammatory mediators and metabolic products. In past medical explorations, traditional research models were often confined to single-dimensional observations. This "panoramic view through a tube" approach struggled to reveal the intrinsic connections between macroscopic signs and microscopic molecular mechanisms during the development of cachexia. In recent years, with the advancement of high-throughput biotechnology, "multi-omics" integrated analysis has become a key approach for deciphering such complex diseases. This study aims to overcome traditional limitations by innovatively constructing a panoramic systemic model: the investigators will utilize imaging omics to deeply mine muscle mass and fat infiltration characteristics invisible to the naked eye in CT data, combine pathological omics to observe tumor microenvironment-induced pathological remodeling at the cellular level, simultaneously employ metabolomics to track metabolic dynamic fingerprints in blood and feces, and apply metagenomics to analyze the microecological composition of the "gut-muscle axis." Through this deep integration spanning macro and micro levels, structure and function, the investigators aim to map a comprehensive molecular atlas of cachexia onset and progression, thereby precisely identifying therapeutic targets capable of reversing this pathological process. This multi-level cross-disciplinary research enables the field to transcend the limitations of traditional perspectives, revealing a comprehensive mechanism by which tumors induce muscle and fat loss through altering metabolic environments, reshaping gut microbiota, and inducing histopathological changes-from macroscopic alterations in body composition to microscopic molecular metabolic pathways.
- Conditions
- Cachexia; Cancer; Sarcopenia
- Being tested
- Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients, Standard nutritional intervention was administered as a positive control to validate experimental efficacy., Administration of placebo as a negative control to validate experimental efficacy
- Keywords
- cancer associated cachexia, Multi-omics Integrated Analysis, Mechanism Exploration and Reversal Strategy Research
- Medical subject headings
- Cachexia, Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patientsDrug
Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients
Standard nutritional intervention was administered as a positive control to validate experimental efficacy.Drug
Standard nutritional intervention was administered as a positive control to validate experimental efficacy.
Administration of placebo as a negative control to validate experimental efficacyOther
Administration of placebo as a negative control to validate experimental efficacy
| Study group | Role | What they receive |
|---|---|---|
| No nutritional intervention | Placebo comparator | No intervention was applied as a negative control to validate the experimental effect. Receives: Other: Administration of placebo as a negative control to validate experimental efficacy |
| Standard Nutritional Intervention | Active comparator | Standard intervention was administered as a positive control to validate experimental efficacy. Receives: Drug: Standard nutritional intervention was administered as a positive control to validate experimental efficacy. |
| Enhanced Nutritional Intervention | Active comparator | Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients Receives: Drug: Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal muscle index (SMI, cm²/m²)
Skeletal muscle index (SMI) is calculated from cross-sectional CT images at the third lumbar vertebra (L3) level and normalized by height (cm²/m²).
Measured: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Secondary outcomes (7)
Change in serum albumin (g/L)
Serum albumin level measured using standard laboratory methods.
Measured: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in C-reactive protein (CRP, mg/L)
CRP levels measured as a marker of systemic inflammation.
Measured: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in handgrip strength (kg)
Handgrip strength measured using a calibrated dynamometer.
Measured: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in gait speed (m/s)
Gait speed assessed using a standardized walking test.
Measured: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in visceral adipose tissue area (cm²)
Visceral fat area quantified from CT images at the L3 level.
Measured: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in subcutaneous adipose tissue area (cm²)
Subcutaneous fat area quantified from CT images at the L3 level.
Measured: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in skeletal muscle area (cm²)
Skeletal muscle area measured from CT images at the L3 level.
Measured: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start18 Mar 2026
- Primary completion20 Mar 2028 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia; Cancer; 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Li, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519837
- Sponsor's protocol ID
- 2026-124-2
- Acronym
- PRCC-MO
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Pathogenesis and Reversal Strategies of Cancer Cachexia Based on Multi-Omics
- ClinicalTrials.gov ID
- NCT07519837
- Acronym / sponsor ID
- PRCC-MO / 2026-124-2
- Conditions
- Cachexia; Cancer; Sarcopenia
- Keywords
- cancer associated cachexia, Multi-omics Integrated Analysis, Mechanism Exploration and Reversal Strategy Research
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 20 Mar 2028 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 9 Apr 2026 (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.
Cancer cachexia is a complex systemic metabolic syndrome with high incidence and mortality rates, significantly impacting the prognosis and survival of cancer patients.Current clinical comprehensive intervention approaches can only provide transient symptom relief and fail to fundamentally block or reverse muscle and fat loss. The core challenge lies in the extreme complexity of this pathological mechanism and the lack of early biomarkers.To overcome the limitations of traditional single-dimensional research approaches, this study proposes a combined analysis method utilizing "multi-omics" (imaging omics, pathological omics, metabolomics, and metagenomics) to construct a panoramic systemic model spanning macroscopic clinical manifestations and microscopic molecular processes. The aim is to comprehensively elucidate the pathogenesis and metabolic pathways of cachexia, thereby precisely identifying potential therapeutic targets capable of reversing this pathological process.
Detailed description
Cancer cachexia is a multifactorial metabolic syndrome characterized by persistent skeletal muscle atrophy, with or without loss of adipose tissue. It differs from conventional malnutrition, for which conventional nutritional support often fails to fully reverse its progression. Cachexia has an extremely high incidence rate in patients with advanced cancer, with an overall prevalence ranging from approximately 50% to 80%. Especially in malignant tumors of the digestive system such as gastric cancer, colorectal cancer, and pancreatic cancer, the incidence of cachexia is higher due to direct involvement of digestive organs by tumors, and the disease prognosis is often more severe. Existing medical evidence indicates that cancer cachexia is closely associated with poor prognosis. Cachexia not only leads to a sharp decline in physical condition and impairment of quality of life, but also significantly reduces tolerance to chemotherapy, radiotherapy, and surgery, while increasing treatment-related toxic side effects. According to statistics, approximately 20% to 30% of cancer-related deaths are not directly attributable to increased tumor burden, but rather to cardiopulmonary failure and metabolic collapse caused by cachexia. Therefore, controlling and reversing cachexia is a critical step in prolonging survival and improving treatment outcomes.
At present, clinical treatment of cancer cachexia does not rely on a single approach but rather tends to adopt a "multimodal comprehensive intervention strategy." Specifically, this strategy encompasses enhanced nutritional support therapy (such as providing high-protein, high-calorie enteral/parenteral nutrition formulations), pharmacological interventions (including the use of progestogens to improve appetite and nonsteroidal anti-inflammatory drugs to counter systemic inflammatory responses), and targeted rehabilitation physical training, aiming to maintain functional status through a multidisciplinary approach. However, it must be acknowledged that despite the implementation of the aforementioned comprehensive measures, significant limitations in clinical efficacy remain. In clinical practice, these interventions often only provide temporary symptomatic relief to a limited extent (e.g., short-term improvement in appetite or slowing of weight loss rate), but fail to fundamentally block the "molecular switch" underlying skeletal muscle protein degradation, nor can these interventions effectively reverse already established muscle atrophy and functional decline. The fundamental reason for this dilemma lies in the extreme complexity of the pathogenesis of cachexia. Cachexia is not merely "malnutrition," but rather a "metabolic storm" involving abnormal regulation of multiple organs (muscle, adipose tissue, liver, intestine, etc.) and systems (immune, neuroendocrine, metabolic) throughout the body. Current treatments often only address downstream symptoms without correcting the complex upstream molecular dysregulation. More critically, there is currently an extreme lack of in-depth understanding of the early activation mechanisms of cachexia in clinical practice, and no reliable, high-sensitivity biomarkers (such as specific blood parameters or imaging features) are available. This results in the vast majority of patients being diagnosed with cachexia when the body is already in a severe catabolic state (resistant phase), thereby missing the optimal time window for early intervention and disease reversal.
Cancer cachexia is essentially a highly complex systemic metabolic disorder syndrome, with core pathology stemming from extensive and profound abnormal interactions between tumors and the host. These interactions are not confined to the tumor site but also trigger multi-organ functional remodeling, including skeletal muscle and adipose tissue, through inflammatory mediators and metabolic products. In past medical explorations, traditional research models were often confined to single-dimensional observations. This "panoramic view through a tube" approach struggled to reveal the intrinsic connections between macroscopic signs and microscopic molecular mechanisms during the development of cachexia. In recent years, with the advancement of high-throughput biotechnology, "multi-omics" integrated analysis has become a key approach for deciphering such complex diseases. This study aims to overcome traditional limitations by innovatively constructing a panoramic systemic model: the investigators will utilize imaging omics to deeply mine muscle mass and fat infiltration characteristics invisible to the naked eye in CT data, combine pathological omics to observe tumor microenvironment-induced pathological remodeling at the cellular level, simultaneously employ metabolomics to track metabolic dynamic fingerprints in blood and feces, and apply metagenomics to analyze the microecological composition of the "gut-muscle axis." Through this deep integration spanning macro and micro levels, structure and function, the investigators aim to map a comprehensive molecular atlas of cachexia onset and progression, thereby precisely identifying therapeutic targets capable of reversing this pathological process. This multi-level cross-disciplinary research enables the field to transcend the limitations of traditional perspectives, revealing a comprehensive mechanism by which tumors induce muscle and fat loss through altering metabolic environments, reshaping gut microbiota, and inducing histopathological changes-from macroscopic alterations in body composition to microscopic molecular metabolic pathways.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No nutritional intervention | Placebo comparator | Other: Administration of placebo as a negative control to validate experimental efficacyNo intervention was applied as a negative control to validate the experimental effect. |
| Standard Nutritional Intervention | Active comparator | Drug: Standard nutritional intervention was administered as a positive control to validate experimental efficacy.Standard intervention was administered as a positive control to validate experimental efficacy. |
| Enhanced Nutritional Intervention | Active comparator | Drug: Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patientsValidation of intervention efficacy through enhanced intervention in nutritionally high-risk patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Signed informed consent form and voluntary participation in this study
- Histologically and/or cytologically confirmed diagnosis of cancer
- Patients with gastrointestinal malignancies, including:
- Esophageal cancer
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Presence of contraindications to surgery
- Cognitive dysfunction, psychiatric disorders, impaired consciousness, or inability/unwillingness to cooperate
- Presence of two or more concurrent primary tumors
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 |
|---|---|---|
| Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patientsValidation of intervention efficacy through enhanced intervention in nutritionally high-risk patients | Drug | Enhanced Nutritional Intervention |
| Standard nutritional intervention was administered as a positive control to validate experimental efficacy.Standard nutritional intervention was administered as a positive control to validate experimental efficacy. | Drug | Standard Nutritional Intervention |
| Administration of placebo as a negative control to validate experimental efficacyAdministration of placebo as a negative control to validate experimental efficacy | Other | No nutritional intervention |
Primary outcome
Change in skeletal muscle index (SMI, cm²/m²)
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Skeletal muscle index (SMI) is calculated from cross-sectional CT images at the third lumbar vertebra (L3) level and normalized by height (cm²/m²).
7 secondary outcomes
Change in serum albumin (g/L)
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in C-reactive protein (CRP, mg/L)
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in handgrip strength (kg)
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in gait speed (m/s)
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in visceral adipose tissue area (cm²)
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in subcutaneous adipose tissue area (cm²)
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in skeletal muscle area (cm²)
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients in people with Cachexia; Cancer; Sarcopenia, run by China Medical University, China at 1 site in China.
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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanwen Liu (+86 18941960007, X18941960007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skeletal muscle index (SMI, cm²/m²) (time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 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 Apr 2026.