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

Primary Purpose

Geriatric Assessment, Cancer, Cancer Cachexia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Physical training
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geriatric Assessment focused on measuring Geriatric cancer, Cancer cachexia, Physical training, Severity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical training

Arm Description

Supervised patient-tailored intensity-modulated physical training

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Integrated Care for Older People Guidelines score (ICOPE)
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".
Physical Activity Performance Scale
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.

Full Information

First Posted
May 20, 2023
Last Updated
June 13, 2023
Sponsor
National Cheng-Kung University Hospital
Collaborators
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT05915325
Brief Title
Physical Training for Elderly Cancer Patients With Cachexia
Acronym
TEECH-01
Official Title
Physical Training for Elderly Cancer Patients With Cachexia (TEECH-01): a Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geriatric Assessment, Cancer, Cancer Cachexia
Keywords
Geriatric cancer, Cancer cachexia, Physical training, Severity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm intervention trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical training
Arm Type
Experimental
Arm Description
Supervised patient-tailored intensity-modulated physical training
Intervention Type
Procedure
Intervention Name(s)
Physical training
Intervention Description
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 Nutrition intervention for 24 weeks: Dietitian consultation, education and intervention for 24 weeks
Primary Outcome Measure Information:
Title
Simplified cancer CAchexia SCOre (MiniCASCO)
Description
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)
Time Frame
Change from week 0 (trial enrollment) to week 12 (end of training)
Secondary Outcome Measure Information:
Title
Integrated Care for Older People Guidelines score (ICOPE)
Description
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".
Time Frame
Change from week 0 (trial enrollment) to week 12 (end of training)
Title
Physical Activity Performance Scale
Description
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.
Time Frame
Change from week 0 (trial enrollment) to week 12 (end of training)
Other Pre-specified Outcome Measures:
Title
European Organisation for Research and Treatment of Cancer-Quality of Life Cancer C30 (EORTC-QLQ-C30)
Description
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.
Time Frame
Change from trial enrollment (week 0) to week 12 (end of training)
Title
Mini Nutritional Assessment Short-Form (MNA-SF)
Description
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.
Time Frame
Change from trial enrollment (week 0) to week 12 (end of training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih Chieh Yen, MD
Phone
886-6-2353535
Ext
6550
Email
jack7481@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Hsuan Lin
Phone
886-6-2353535
Ext
6050
Email
t26091018@gs.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih Chieh Yen, MD
Organizational Affiliation
Department of Oncology, National Cheng Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih Chieh Yen, MD
Phone
+886-6-2353535
Ext
6550
Email
jack7481@gmail.com
First Name & Middle Initial & Last Name & Degree
Yi Hsuan Lin
Phone
+886-6-2353535
Ext
6050
Email
t26091018@gs.ncku.edu.tw
First Name & Middle Initial & Last Name & Degree
Jui Hung Tsai, MD
First Name & Middle Initial & Last Name & Degree
I Ting Liu, MD
First Name & Middle Initial & Last Name & Degree
Ying Tzu Huang, MD
First Name & Middle Initial & Last Name & Degree
Shuen Ru Yang, MD
First Name & Middle Initial & Last Name & Degree
Sheng Fu Liang, Ph.D.
First Name & Middle Initial & Last Name & Degree
Li Chieh Kuo, Ph.D.
First Name & Middle Initial & Last Name & Degree
Chih Chun Lin, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study protocol, statistical analysis plan and individual information are to be shared upon reasonable request to the study principal investigator.
Citations:
PubMed Identifier
34519440
Citation
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.
Results Reference
background
PubMed Identifier
28261113
Citation
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.
Results Reference
background
PubMed Identifier
35305110
Citation
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.
Results Reference
background
PubMed Identifier
30829460
Citation
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.
Results Reference
background
PubMed Identifier
34498352
Citation
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.
Results Reference
background
Links:
URL
https://mdic.ncku.edu.tw/
Description
Medical Device Innovation Center, National Cheng Kung University
URL
https://www.hosp.ncku.edu.tw/GH/about.html
Description
Geriatric Health Center, National Cheng Kung University Hospital
URL
https://www.csie.ncku.edu.tw/zh-hant/ncku_csie/
Description
Department of Computer Science and Information Engineering, National Cheng Kung University

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Physical Training for Elderly Cancer Patients With Cachexia

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