CancerNCT04654637
Multiple Interactive With Nutrition and Exercise Strategies in Frailty Cancer Patients
A study testing Nutrition and Exercise Strategies in people with Cancer, run by Tzu Chi University at 1 site in Taiwan.
Trial summary
Due to the changes in lifestyle caused by the COVID-19, it is a priority to provide multi-interactive digital platforms and social media for nutrition and exercise programs for cancer patients. A two-year serial program uses mixed study methods of longitudinal combined experimental study. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cancer
- What is being tested?
- Nutrition and Exercise Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2020to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 20-85 years with histological confirmation malignancy.
- Requiring treatment by surgery, chemotherapy, hormonotherapy, radiotherapy, or targeted therapy with a curative intention as estimated by oncologists.
- First diagnosed or recurrence of head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, AML, ALL, lymphoma, multiple myeloma.
Who cannot join
- Non-head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, AML, ALL, lymphoma, multiple myeloma with first diagnosis or recurrence patients.
- Eastern Cooperative Oncology Group test score>2.
- Serious psychiatric or cognitive problems, and functional disability leading to a total inability to walk.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tzu Chi University
Hualien City, 90093
Chun Hou Huang, Phd, 886-978650985, hou2017@gms.tcu.edu.tw
About this study
Official title: Department of Nursing, Tzu Chi University, Hualien, Taiwan
Due to the changes in lifestyle caused by the COVID-19, it is a priority to provide multi-interactive digital platforms and social media for nutrition and exercise programs for cancer patients. A two-year serial program uses mixed study methods of longitudinal combined experimental study. We will investigate cancer frailty's current situation and track the frailty trends after cancer patients received different treatments. We will also invite experts to develop multi-interactive digital platforms of nutrition and performance-based tailored circuit training programs according to the cancer frailty survey. We will recruit 20-85 years of newly diagnosed or first-time recurrence cancer patients and stratified randomization assigned to evaluate nutrition and physical exercise intervention effectiveness. The measure indicators were treatment-related adverse events, nutritional status, frailty status, survival rate, and life quality.
- Conditions
- Cancer
- Being tested
- Nutrition and Exercise Strategies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and Exercise StrategiesBehavioural
Multiple Interactive with Nutrition and Exercise Strategies
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | fix model of cycle exercise(online supervise) and routine nutrition consult Receives: Behavioral: Nutrition and Exercise Strategies |
| Arm B | Experimental | fix model of cycle exercise(online supervise) and online nutrition consult Receives: Behavioral: Nutrition and Exercise Strategies |
| Arm C | Experimental | individualize cycle exercise(online supervise) and routine nutrition consult Receives: Behavioral: Nutrition and Exercise Strategies |
| Arm D | Experimental | individualize cycle exercise(online supervise) and online nutrition consult Receives: Behavioral: Nutrition and Exercise Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty trend
After treatment frailty condition
Measured: After treatment three-month
Secondary outcomes (1)
Treatment-related adverse events
CTCAE or Clavien-Dindo classification
Measured: After treatment one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Nov 2020
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Arm A: fix model of cycle exercise(online supervise) and routine nutrition consult Arm B: fix model of cycle exercise(online supervise) and online nutrition consult Arm C: individualize cycle exercise(online supervise) and routine nutrition consult Arm D: individualize cycle exercise(online supervise) and online nutrition consult
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tzu Chi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Hou Huang, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654637
- Sponsor's protocol ID
- TCU-CHHuang
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Nursing, Tzu Chi University, Hualien, Taiwan
- ClinicalTrials.gov ID
- NCT04654637
- Acronym / sponsor ID
- TCU-CHHuang
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Tzu Chi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 4 Dec 2020 (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.
Due to the changes in lifestyle caused by the COVID-19, it is a priority to provide multi-interactive digital platforms and social media for nutrition and exercise programs for cancer patients. A two-year serial program uses mixed study methods of longitudinal combined experimental study. We will investigate cancer frailty's current situation and track the frailty trends after cancer patients received different treatments. We will also invite experts to develop multi-interactive digital platforms of nutrition and performance-based tailored circuit training programs according to the cancer frailty survey. We will recruit 20-85 years of newly diagnosed or first-time recurrence cancer patients and stratified randomization assigned to evaluate nutrition and physical exercise intervention effectiveness. The measure indicators were treatment-related adverse events, nutritional status, frailty status, survival rate, and life quality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Arm A: fix model of cycle exercise(online supervise) and routine nutrition consult Arm B: fix model of cycle exercise(online supervise) and online nutrition consult Arm C: individualize cycle exercise(online supervise) and routine nutrition consult Arm D: individualize cycle exercise(online supervise) and online nutrition consult
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Behavioral: Nutrition and Exercise Strategiesfix model of cycle exercise(online supervise) and routine nutrition consult |
| Arm B | Experimental | Behavioral: Nutrition and Exercise Strategiesfix model of cycle exercise(online supervise) and online nutrition consult |
| Arm C | Experimental | Behavioral: Nutrition and Exercise Strategiesindividualize cycle exercise(online supervise) and routine nutrition consult |
| Arm D | Experimental | Behavioral: Nutrition and Exercise Strategiesindividualize cycle exercise(online supervise) and online nutrition consult |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged from 20-85 years with histological confirmation malignancy.
- Requiring treatment by surgery, chemotherapy, hormonotherapy, radiotherapy, or targeted therapy with a curative intention as estimated by oncologists.
- First diagnosed or recurrence of head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, AML, ALL, lymphoma, multiple myeloma.
Key exclusion criteria (3 listed)
- Non-head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, AML, ALL, lymphoma, multiple myeloma with first diagnosis or recurrence patients.
- Eastern Cooperative Oncology Group test score>2.
- Serious psychiatric or cognitive problems, and functional disability leading to a total inability to walk.
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 |
|---|---|---|
| Nutrition and Exercise StrategiesMultiple Interactive with Nutrition and Exercise Strategies | Behavioural | Arm A, Arm B, Arm C, Arm D |
Primary outcome
Frailty trend
Time frame: After treatment three-month
After treatment frailty condition
1 secondary outcome
Treatment-related adverse events
Time frame: After treatment one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and Exercise Strategies in people with Cancer, run by Tzu Chi University 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chu Hou Huang, PhD (886-3-565301 ext. 2227, hou2017@gms.tcu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty trend (time frame: After treatment three-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2020.