An interventional study of Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients and Standard nutritional intervention was administered as a positive control to validate experimental efficacy. in Cachexia; Cancer; Sarcopenia, sponsored by China Medical University, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by China Medical University, China · Not applicable, Interventional, and Basic science
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.
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.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 74 across 226 interventional studies indexed under Cachexia.
Browse Cachexia studies →China Medical University, China is the lead sponsor of 94 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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No intervention was applied as a negative control to validate the experimental effect.
Other: Administration of placebo as a negative control to validate experimental efficacy
Standard 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.
Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients
Drug: Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients
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
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).
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in serum albumin (g/L)
Serum albumin level measured using standard laboratory methods.
Time frame: 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.
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Change in handgrip strength (kg)
Handgrip strength measured using a calibrated dynamometer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)
Plan to share: No
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Started Mar 2026 (actual). Primary completion is estimated for Mar 2028, 24 months after the start.
Of 75 non-industry interventional studies with no phase under Cachexia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's planned 24 months is above that.
Counting every sponsor, half of 77 studies reached it within 19 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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China Medical University, China