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Exploring whether multimodal rehabilitation can improve treatment response and quality of life in advanced cancer patients

A Randomized Controlled Trial of Multimodal Rehabilitation to Improve Treatment Tolerance and Reduce Adverse Effects in Patients Undergoing Antitumor Therapy for Advanced Cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107102
Enrollment
Unknown
Registered
2025-08-04
Start date
2025-04-29
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with advanced solid tumors (e.g., gastric cancer, lung cancer)

Interventions

Intervention Group:Multimodal Rehabilitation + Standard Antitumor Treatment Group
Control Group:Routine Antitumor Therapy + Basic Health Education

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older; 2. Patients with histologically and/or cytologically confirmed diagnosis of advanced malignant tumors. 3. Currently undergoing antitumor therapy at the study site; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2 and/or Karnofsky Performance Status (KPS) score =60, indicating the ability to participate in light to moderate intensity physical activity. 5. Assessed by a specialist physician to be physically capable of safely engaging in the prescribed forms of exercise; for patients with comorbid chronic diseases (e.g., diabetes, hypertension), their conditions must be under basic control and not pose significant risks during exercise. 6. Willing to voluntarily participate in the study and able to provide written informed consent. If the subject lacks legal capacity to consent, the consent process must be conducted and signed by a legal guardian. If the subject is unable to read (e.g., illiterate participants), the consent process must be witnessed and signed by an impartial witness.

Exclusion criteria

Exclusion criteria: 1. Severe contraindications to exercise, including but not limited to serious cardiovascular, respiratory, neurological, or other medical conditions that may affect exercise safety (e.g., recent myocardial infarction, acute heart failure, severe osteoporosis with high fracture risk). 2. Patients with severe hepatic or renal insufficiency. 3. Patients with poorly controlled diabetes (fasting blood glucose >=13.3 mmol/L). 4. Uncontrolled pain (numeric rating scale >3); 5. Uncontrolled pleural or peritoneal effusion requiring repeated drainage; 6. Uncontrolled severe infections; 7. Uncontrolled deep vein thrombosis (DVT) of the lower limbs. 8. Patients at high risk of bleeding; 9. Vulnerable populations other than elderly or illiterate individuals, including those with psychiatric disorders, cognitive impairment, critically ill conditions, or pregnancy.

Design outcomes

Primary

MeasureTime frame
Incidence of treatment-related adverse events (>= Grade 2, CTCAE);

Secondary

MeasureTime frame
Inflammatory Cytokines (IL-6?TNF-a);Fatigue Score;Hematological Parameters (Complete Blood Count, CBC);Plasma proteomics of inflammation, immunity, and metabolism-related proteins;Sleep quality score;Tumor Markers (e.g., CEA, CA19-9);Five Times Sit-to-Stand Test Time (5STS);Grip Strength;Physical Activity Level;Body Composition Score (BIA);Six-Minute Walk Test;Serum Nutritional Markers (e.g., Prealbumin, Albumin);Anxiety and Depression Score (HADS);Cognitive Function Score;Quality of life score (EORTC QLQ-C30);Immune Function Markers (Lymphocyte Subsets, Immunoglobulins);CT-based Body Composition Indicators (SMA, SMI, VFA);Composition of gut microbiota (e.g., species and abundance of bacteria);

Countries

China

Contacts

Public ContactPan Qin

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

tianpanqin@yeah.net+86 136 0650 8048

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026