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

NCT07519837 | Recruiting DMC

• 1 other identifier: 2026-124-2
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cachexia; Cancer; Sarcopenia

Keywords

cancer associated cachexia; Multi-omics Integrated Analysis; Mechanism Exploration and Reversal Strategy Research

Outcome Measures

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).

  Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

Secondary Outcomes (7)

• Change in serum albumin (g/L)

  Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

• Change in C-reactive protein (CRP, mg/L)

  Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

• Change in handgrip strength (kg)

  Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

• Change in gait speed (m/s)

  Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

• Change in visceral adipose tissue area (cm²)

  Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

Study Arms (3)

No nutritional intervention

PLACEBO COMPARATOR

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 Nutritional Intervention

ACTIVE COMPARATOR

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.

Enhanced Nutritional Intervention

ACTIVE COMPARATOR

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

Interventions

Administration of placebo as a negative control to validate experimental efficacy OTHER

Administration of placebo as a negative control to validate experimental efficacy

No nutritional intervention

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

Enhanced Nutritional Intervention

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.

Standard Nutritional Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Gastric cancer
• Cholangiocarcinoma
• Patients undergoing histopathological examination of primary lesion biopsy or gastrointestinal endoscopic biopsy

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Cachexia; Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Central Study Contacts

Hanwen Liu

CONTACT

+86 18941960007; X18941960007@126.com

XiaoXu Liu

CONTACT

+86 18042901898; X18941960007@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Gastrointestinal Oncology Surgery, The First Affiliated Hospital of China Medical University

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 9, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 20, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)