Ireland
--:--IST
Completed Not applicable

Physical Training for Elderly Cancer Patients With Cachexia

NCT05915325 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2023-07-05
Last updated
2026-11-13

Condition(s) studied

Geriatric AssessmentCancerCancer Cachexia

Investigational drug(s) / intervention(s)

Physical training

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

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Simplified cancer CAchexia SCOre (MiniCASCO) — Change from week 0 (trial enrollment) to week 12 (end of training)
    A simplified version for the scoring of the severity of cancer cachexia: A total score of 0 to 100 points are recorded and graded as minimal (0 to 14), mild (15 to 28), moderate (29 to 46) or severe cachexia (47 to 100)

Trial sites (1)

FacilityCityRegionStatus
National Cheng Kung University Hospital Tainan Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05915325 on ClinicalTrials.gov ↗ ← All trials in Taiwan