NCT05915325

Physical Training for Elderly Cancer Patients With Cachexia

Physical Training for Elderly Cancer Patients With Cachexia (TEECH-01): a Prospective Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of the clinical trial is to evaluate the feasibility and efficacy of physical training for elderly cancer patients at risk of cancer cachexia. The main questions it aims to answer are: * Whether a physical training program is feasible in elderly cancer patients with cachexia? * What is the efficacy of a physical training program in reducing the severity of cancer cachexia in elderly cancer patients? Participants will receive a 12-week supervised patient-tailored intensity-modulated physical training and being assessed for the severity of cancer cachexia before and after the training.

Detailed description

The trial is to investigate the feasibility and efficacy of an artificial intelligence-based patient-tailored intensity-modulated physical training for cancer patients aged over 65 at risk of cancer cachexia. The primary endpoint is simplified cancer CAchexia SCOre (MiniCASCO) reduction. Secondary endpoints include geriatric assessment, physical activity and sarcopenia. This is an open-label, single-arm, single-center phase II investigator-initiated trial. The investigators assume a reduction of MiniCASCO by 10% after trial intervention. Under a statistical power of 80% and a probability of type I error at 0.1 (two-tailed), a minimal of 49 participants will be enrolled. All participants will receive a 12-week supervised physical training and nutritional intervention. Efficacy assessments will be conducted at baseline (week 0), post-intervention (week 12) and follow-up period (week 24). The investigators anticipate that the optimal patient-tailored training program is feasible and improves the symptoms and severity of elderly cancer cachexia. The results may shed light on the debilitating and burdensome condition and provide information on future clinical trials.

Conditions

• Geriatric Assessment
• Cancer
• Cancer Cachexia

Interventions

Type	Name	Description
PROCEDURE	Physical training	1. Supervised Physical Training in SeniorGym for 12 weeks: 1) Aerobic exercise: Patient-tailored intensity-modulated ergometer training for the limbs; 2) Resistance exercise: Patient-tailored resistance exercise by Theraband for the limbs 2. Nutrition intervention for 24 weeks: Dietitian consultation, education and intervention for 24 weeks

Timeline

• Start date: 2023-07-05
• Primary completion: 2025-07-01
• Completion: 2026-01-05
• First posted: 2023-06-23
• Last updated: 2025-05-21

Locations

1 site across 1 country: Taiwan