Physical Training for Elderly Cancer Patients With Cachexia

Trial Title: Physical Training for Elderly Cancer Patients With Cachexia

NCT ID: NCT05915325

Condition: Geriatric Assessment
Cancer
Cancer Cachexia

Conditions: Official terms:
Wasting Syndrome
Cachexia

Conditions: Keywords:
Geriatric cancer
Cancer cachexia
Physical training
Severity

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Single-arm intervention trial

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Physical training
Description: 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
Arm group label: Physical training

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Subjects aged equivalent to or over 65 years with an existing cancer requiring antineoplastic treatments at trial enrollment, as defined by presence of a catastrophic disease certificate for malignancy in National Health Insurance (NHI)-Taiwan. 2. Subjects receive at least one systemic antineoplastic treatment within 12 weeks since trial enrollment, which includes chemotherapy, immunotherapy, hormonal, targeted and cellular therapy of whichever initial therapeutic intent (curative, palliative or salvage). 3. Subjects fulfill either cancer cachexia or pre-cachexia. (3.1) Cancer cachexia: A maximal weight loss of at least 5% from the baseline within 6 months in those whose BMI equivalent to or over 20 kg/m2 or at least 2% in those whose BMI less than 20 kg/m2; (3.2) Pre-cachexia: A maximal weight loss of 1% to 5% from the baseline within 6 months in patients whose BMI equivalent to or over 20 kg/m2 or 1% to 2% in those whose BMI less than 20 kg/m2 plus any of the following: an elevated serum C-reactive protein above upper normal limits (ULN), impaired fasting glucose or known diabetes mellitus, use of high-dose corticosteroid (over 10 mg prednisone equivalent daily), hypogonadism (disease-related or iatrogenic) or insufficient calorie intake of less than 20 kcal/kg/day 4. Subjects are in a clinical status with an expected life span exceeding 6 months and Eastern Cooperative Oncology Group (ECOG) 0 to 1 or Karnofsky Performance Scale (KPS) 80 to 100 at trial enrollment. 5. Subjects are physically and mentally capable and willing for conducting the planned physical training and agreed to comply the educational instructions and a wearable device during trial intervention. 6. Subjects are functionally and cognitively capable to be informed of the trial contents and objectives (including obtaining peripheral blood sampling for trial investigation), and agree to sign the written consent for enrollment. Exclusion Criteria: 1. Subjects have tumor in situ or curatively treated malignant disease which requires no further antineoplastic treatments. 2. Subjects are anticipated to receive any surgery, radiotherapy or intervention that prevents or hinders a planned physical training within 28 weeks since trial enrollment. 3. Subjects experience a progressive body weight loss which fulfills the criteria for cancer cachexia or pre-cachexia but complicates with other confounding causes. 4. Subjects have cachexia caused by etiologies not limited to cancer. 5. Subject's malignant disease is considered unstable and thereby unfit for a planned physical training. 6. Subjects have an underlying medical illness causing severely impaired organ functions. 7. Subjects have an active infection requiring hospitalized treatment or intravenous anti-pathogen therapies. 8. Subjects who receive other experimental treatments or interventions for cancer cachexia. 9. Subjects are planning to conceive or already in pregnancy. 10. Subjects are currently participating in any other observational studies concerning cancer cachexia.

Gender: All

Minimum age: 65 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Zip: 704
Country: Taiwan

Status: Recruiting

Contact:
Last name: Chih Chieh Yen, MD

Phone: +886-6-2353535

Phone ext: 6550
Email: jack7481@gmail.com

Contact backup:
Last name: Yi Hsuan Lin

Phone: +886-6-2353535

Phone ext: 6050
Email: t26091018@gs.ncku.edu.tw

Investigator:
Last name: Jui Hung Tsai, MD
Email: Principal Investigator

Investigator:
Last name: I Ting Liu, MD
Email: Sub-Investigator

Investigator:
Last name: Ying Tzu Huang, MD
Email: Sub-Investigator

Investigator:
Last name: Shuen Ru Yang, MD
Email: Sub-Investigator

Investigator:
Last name: Sheng Fu Liang, Ph.D.
Email: Sub-Investigator

Investigator:
Last name: Li Chieh Kuo, Ph.D.
Email: Sub-Investigator

Investigator:
Last name: Chih Chun Lin, Ph.D.
Email: Sub-Investigator

Start date: July 5, 2023

Completion date: January 5, 2026

Lead sponsor:
Agency: National Cheng-Kung University Hospital
Agency class: Other

Collaborator:
Agency: National Cheng Kung University
Agency class: Other

Source: National Cheng-Kung University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05915325
https://mdic.ncku.edu.tw/
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