Study on the Pathogenesis and Reversal Strategies of Cancer Cachexia Based on Multi-Omics

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina Medical University, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Signed informed consent form and voluntary participation in this study

Histologically and/or cytologically confirmed diagnosis of cancer

Esophageal cancer

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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 efficacy

    Other intervention

    Administration of placebo as a negative control to validate experimental efficacy

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: No nutritional interventionPlacebo comparator 1 intervention
Group B: Standard Nutritional InterventionActive comparator 1 intervention
Group C: Enhanced Nutritional InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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