Geriatric AssessmentTEECH-01NCT05915325
Physical Training for Elderly Cancer Patients With Cachexia
A study testing Physical training in people with Geriatric Assessment and Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Assessment, Cancer, Cancer Cachexia
- What is being tested?
- Physical training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jul 2023to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Geriatric Assessment, Cancer, Cancer Cachexia
- Being tested
- Physical training
- Keywords
- Geriatric cancer, Cancer cachexia, Physical training, Severity
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Physical training | Experimental | Supervised patient-tailored intensity-modulated physical training Receives: Procedure: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from week 0 (trial enrollment) to week 12 (end of training)
Secondary outcomes (2)
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".
Measured: Change from week 0 (trial enrollment) to week 12 (end of training)
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.
Measured: Change from week 0 (trial enrollment) to week 12 (end of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start5 Jul 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion5 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Geriatric AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm intervention trial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng Kung University
- Responsible party
- Principal investigator, Chih Chieh, Yen, National Cheng-Kung University Hospital
- Investigators
- Chih Chieh Yen, MD, Principal investigator, Department of Oncology, National Cheng Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915325
- Sponsor's protocol ID
- TEECH-01
- Acronym
- TEECH-01
- Status last verified
- May 2025
- First submitted
- 20 May 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol, statistical analysis plan and individual information are to be shared upon reasonable request to the study principal investigator.
Publications
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.
PubMed 34519440Argiles 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.
PubMed 28261113Small 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.
PubMed 35305110Arrieta 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.
PubMed 30829460Mikkelsen 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.
PubMed 34498352
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Training for Elderly Cancer Patients With Cachexia (TEECH-01): a Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT05915325
- Acronym / sponsor ID
- TEECH-01 / TEECH-01
- Conditions
- Geriatric Assessment, Cancer, Cancer Cachexia
- Keywords
- Geriatric cancer, Cancer cachexia, Physical training, Severity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- National Cheng Kung University
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 5 Jan 2026 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm intervention trial
| Arm | Type | Receives |
|---|---|---|
| Physical training | Experimental | Procedure: Physical trainingSupervised patient-tailored intensity-modulated physical training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical training1. 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 | Procedure or surgery | Physical training |
Primary outcome
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)
2 secondary outcomes
Integrated Care for Older People Guidelines score (ICOPE)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 34519440Poisson 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.
- Background: PubMed 28261113Argiles 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.
- Background: PubMed 35305110Small 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.
- Background: PubMed 30829460Arrieta 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.
- Background: PubMed 34498352Mikkelsen 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.
- Medical Device Innovation Center, National Cheng Kung UniversityLink provided by the sponsor.
- Geriatric Health Center, National Cheng Kung University HospitalLink provided by the sponsor.
- Department of Computer Science and Information Engineering, National Cheng Kung UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No. The study protocol, statistical analysis plan and individual information are to be shared upon reasonable request to the study principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih Chieh Yen, MD principal investigator
Department of Oncology, National Cheng Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Geriatric Assessment and Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simplified cancer CAchexia SCOre (MiniCASCO) (time frame: Change from week 0 (trial enrollment) to week 12 (end of training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05915325, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.