Physical Training for Elderly Cancer Patients With Cachexia (TEECH-01)

November 9, 2023 updated by: Chih Chieh, Yen, National Cheng-Kung University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jui Hung Tsai, MD
        • Sub-Investigator:
          • I Ting Liu, MD
        • Sub-Investigator:
          • Ying Tzu Huang, MD
        • Sub-Investigator:
          • Shuen Ru Yang, MD
        • Sub-Investigator:
          • Sheng Fu Liang, Ph.D.
        • Sub-Investigator:
          • Li Chieh Kuo, Ph.D.
        • Sub-Investigator:
          • Chih Chun Lin, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical training
Supervised patient-tailored intensity-modulated physical training
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simplified cancer CAchexia SCOre (MiniCASCO)
Time Frame: 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)
Change from week 0 (trial enrollment) to week 12 (end of training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Integrated Care for Older People Guidelines score (ICOPE)
Time Frame: Change from week 0 (trial enrollment) to week 12 (end of training)

Geriatric assessment:

A total of 6 domains (cognitive, mobility, nutrition, visual, hearing and depressive symptoms) are included and be given a score of 1 on each if screened positive (a total score from 0 to 6). Of those who scored greater than 2 will be considered "impaired".
Change from week 0 (trial enrollment) to week 12 (end of training)
Physical Activity Performance Scale
Time Frame: Change from week 0 (trial enrollment) to week 12 (end of training)

Hand grip strength, Gait speed, Body mass index, Sit-to-stand, Back stretch, Sit reach, Single leg stand, Up-and-go, 2-minute step, 6-minute walk test and Timed up-and-go:

A total of 11 items will be recorded and calculated for the percentage difference, which is equivalent to the {[absolute change between week 12 (end of training) and week 0 (trial enrollment) testing result] / week 0 testing result } x 100 %. A mean percentage difference of the 11 items, ranging from 0 to 100%, will be calculated and of those with a greater mean percentage difference indicate a greater post intervention change.
Change from week 0 (trial enrollment) to week 12 (end of training)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Organisation for Research and Treatment of Cancer-Quality of Life Cancer C30 (EORTC-QLQ-C30)
Time Frame: Change from trial enrollment (week 0) to week 12 (end of training)

Health-related quality of life:

A total of 10 standardized questions from EORTC-QLQ C30 are asked to the participants. The answers are graded as none/not at all, a little/slightly, average/moderately, or a lot/considerably and each question is given 0, 0.25, 0.75 or 1.0 point, respectively. A sum-up score of 0 to 10 will be recorded and of those with a greater score indicate a poorer quality of life.
Change from trial enrollment (week 0) to week 12 (end of training)
Mini Nutritional Assessment Short-Form (MNA-SF)
Time Frame: Change from trial enrollment (week 0) to week 12 (end of training)

Nutrition:

A total of six questions on food intake, weight loss, mobility, psychological stress/acute disease, the presence of dementia/depression, and body mass index will be graded. A total score, ranging from 0 to 14, will be recorded and of those with a score ≤ 11 indicate a nutritional deficit.
Change from trial enrollment (week 0) to week 12 (end of training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Collaborators

National Cheng Kung University

Investigators

  • Principal Investigator: Chih Chieh Yen, MD, Department of Oncology, National Cheng Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Estimated)

January 5, 2025

Study Completion (Estimated)

January 5, 2026

Study Registration Dates

First Submitted

May 20, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEECH-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study protocol, statistical analysis plan and individual information are to be shared upon reasonable request to the study principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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