Physical Training for Elderly Cancer Patients With Cachexia

NCT05915325 | Active Not Recruiting

• 1 other identifier: TEECH-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Geriatric Assessment; Cancer; Cancer Cachexia

Keywords

Geriatric cancer; Cancer cachexia; Physical training; Severity

Outcome Measures

Primary Outcomes (1)

• Simplified cancer CAchexia SCOre (MiniCASCO)

  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)

  Change from week 0 (trial enrollment) to week 12 (end of training)

Secondary Outcomes (2)

• Integrated Care for Older People Guidelines score (ICOPE)

  Change from week 0 (trial enrollment) to week 12 (end of training)

• Physical Activity Performance Scale

  Change from week 0 (trial enrollment) to week 12 (end of training)

Other Outcomes (2)

• European Organisation for Research and Treatment of Cancer-Quality of Life Cancer C30 (EORTC-QLQ-C30)

  Change from trial enrollment (week 0) to week 12 (end of training)

• Mini Nutritional Assessment Short-Form (MNA-SF)

  Change from trial enrollment (week 0) to week 12 (end of training)

Study Arms (1)

Physical training

EXPERIMENTAL

Supervised patient-tailored intensity-modulated physical training

Procedure: Physical training

Interventions

Physical training PROCEDURE

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

Physical training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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).
• 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
• 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.
• 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.
• 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.

You may not qualify if:

• Subjects have tumor in situ or curatively treated malignant disease which requires no further antineoplastic treatments.
• Subjects are anticipated to receive any surgery, radiotherapy or intervention that prevents or hinders a planned physical training within 28 weeks since trial enrollment.
• Subjects experience a progressive body weight loss which fulfills the criteria for cancer cachexia or pre-cachexia but complicates with other confounding causes.
• Subjects have cachexia caused by etiologies not limited to cancer.
• Subject's malignant disease is considered unstable and thereby unfit for a planned physical training.
• Subjects have an underlying medical illness causing severely impaired organ functions.
• Subjects have an active infection requiring hospitalized treatment or intravenous anti-pathogen therapies.
• Subjects who receive other experimental treatments or interventions for cancer cachexia.
• Subjects are planning to conceive or already in pregnancy.
• Subjects are currently participating in any other observational studies concerning cancer cachexia.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• National Cheng Kung University: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (5)

• Poisson J, Martinez-Tapia C, Heitz D, Geiss R, Albrand G, Falandry C, Gisselbrecht M, Couderc AL, Boulahssass R, Liuu E, Boudou-Rouquette P, Chah Wakilian A, Gaxatte C, Pamoukdjian F, de Decker L, Antoine V, Cattenoz C, Solem-Laviec H, Guillem O, Medjenah H, Natella PA, Canoui-Poitrine F, Laurent M, Paillaud E. Prevalence and prognostic impact of cachexia among older patients with cancer: a nationwide cross-sectional survey (NutriAgeCancer). J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1477-1488. doi: 10.1002/jcsm.12776. Epub 2021 Sep 14.

  PMID: 34519440 BACKGROUND

• Argiles JM, Betancourt A, Guardia-Olmos J, Pero-Cebollero M, Lopez-Soriano FJ, Madeddu C, Serpe R, Busquets S. Validation of the CAchexia SCOre (CASCO). Staging Cancer Patients: The Use of miniCASCO as a Simplified Tool. Front Physiol. 2017 Feb 17;8:92. doi: 10.3389/fphys.2017.00092. eCollection 2017.

  PMID: 28261113 BACKGROUND

• Small SD, Bland KA, Rickard JN, Kirkham AA. Exercise-based Multimodal Programming: A Treatment Gap for Older Adults with Advanced Cancer. Oncologist. 2022 Feb 3;27(1):1-3. doi: 10.1093/oncolo/oyab009.

  PMID: 35305110 BACKGROUND

• Arrieta H, Astrugue C, Regueme S, Durrieu J, Maillard A, Rieger A, Terrebonne E, Laurent C, Maget B, Servent V, Lavau-Denes S, Dauba J, Fonck M, Thiebaut R, Bourdel-Marchasson I. Effects of a physical activity programme to prevent physical performance decline in onco-geriatric patients: a randomized multicentre trial. J Cachexia Sarcopenia Muscle. 2019 Apr;10(2):287-297. doi: 10.1002/jcsm.12382. Epub 2019 Mar 4.

  PMID: 30829460 BACKGROUND

• Mikkelsen MK, Lund CM, Vinther A, Tolver A, Johansen JS, Chen I, Ragle AM, Zerahn B, Engell-Noerregaard L, Larsen FO, Theile S, Nielsen DL, Jarden M. Effects of a 12-Week Multimodal Exercise Intervention Among Older Patients with Advanced Cancer: Results from a Randomized Controlled Trial. Oncologist. 2022 Feb 3;27(1):67-78. doi: 10.1002/onco.13970.

  PMID: 34498352 BACKGROUND

Related Links

• Medical Device Innovation Center, National Cheng Kung University
• Geriatric Health Center, National Cheng Kung University Hospital
• Department of Computer Science and Information Engineering, National Cheng Kung University

MeSH Terms

Conditions

Neoplasms

Interventions

Physical Conditioning, Human

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chih Chieh Yen, MD

  Department of Oncology, National Cheng Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Single-arm intervention trial

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: June 23, 2023
• Study Start: July 5, 2023
• Primary Completion: July 1, 2025
• Study Completion: January 5, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)