Differences in Rate of Decline in CT-defined Skeletal Muscle Mass and Physical Performance in Patients With Advanced Non-small Cell Lung Cancer Receiving Chemotherapy and Targeted Therapy/Immunotherapy, Before and After Treatment.

NCT06326086 | Recruiting

• 1 other identifier: REC.65-080-7-1
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is a common disease leading to 18 % of cancer deaths worldwide. Despite various improvement in treatment, there still remains low 5-year survival rate of 10-20 % in advanced lung cancer patients. Skeletal muscle mass and physical performance have been shown to effect overall survival and prognosis in lung cancer. This research focuses on effects of different treatment of lung cancer such as chemotherapy, targeted therapy and immunotherapy on skeletal muscle mass and physical performance.

Conditions

Advanced Lung Cancer; Sarcopenia

Keywords

Chemotherapy, targeted therapy, immunotherapy, NSCLC, sarcopenia, physical performance.

Outcome Measures

Primary Outcomes (1)

• To determine the differences in the rate of decline in CT defined skeletal muscle index at L3 vertebra and physical performance in advanced NSCLC patients receiving chemotherapy and targeted therapy/ immunotherapy, before and after treatment.

  To determine the differences in the rate of decline in CT defined skeletal muscle index at L3 vertebra and physical performance in advanced NSCLC patients receiving chemotherapy and targeted therapy/ immunotherapy, before and after treatment.

  1 year

Secondary Outcomes (1)

• To determine validity of gender based cut off for CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) based on recommendation of JSH/AWGS in Thai population.

  1 year

Other Outcomes (2)

• 2. To determine baseline association between CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) and physical performance using SPPB in advanced NSCLC patients.

  1 year

• 4. To determine differences in rate decline in skeletal muscle mass using CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) in patients receiving first line chemotherapy (CMT) and other line chemotherapy (OCMT).

  1 year

Study Arms (2)

CMT for patients receiving chemotherapy,

Drug: Chemotherapy drug

TKI/IO for patients receiving targeted and immunotherapy

Drug: Targeted Agent; Drug: Immunotherapy

Interventions

Chemotherapy drug DRUG

Chemotherapy drug as prescribed by primary treating physician

CMT for patients receiving chemotherapy,

Targeted Agent DRUG

Targeted agents as prescribed by primary treating physician

TKI/IO for patients receiving targeted and immunotherapy

Immunotherapy DRUG

Immunotherapy as prescribed by primary treating physician

TKI/IO for patients receiving targeted and immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage III and IIIC (if patients are treated with TKI/IO), and Stage IV non-small cell lung cancer patients who are receiving chemotherapy or targeted therapy/immunotherapy (TKI/IO) treated in Songklanagarind Hospital.

You may qualify if:

• Age \>18years old,
• Stage IIIB and IIIC (if patients are treated with TKI/IO), and Stage IV non-small cell lung cancer patients confirmed by histopathology.
• Patients should be either on chemotherapy, molecular targeted therapy or immunotherapy.

You may not qualify if:

• Unable to perform CT scan due to various reasons.
• Patients with metastatic disease at L3 vertebral level.
• If unable to perform SPPB test due to physical disability or patient's refusal.
• Patients with known other primary malignancies. 5 . Patients who have underwent definitive surgery.
• \. Pregnant patients. 7. Patients with physical deformities/neurological deficits which restricts their physical movements.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Carcinoma, Non-Small-Cell Lung

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Shiva R Timsina, MBBS

CONTACT

+660623898980; timsinasraj@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)