Experimental Study DesignsNCT05136573
Exercises on CIPN, Fatigue, and Quality of Life in Colon Cancer Patients Receiving Chemotherapy
A study testing Combined Exercises in people with Experimental Study Designs, run by Chi Mei Medical Hospital.
Trial summary
Objective: Cancer is one of the biggest global health threats. The incidence and mortality of colorectal cancer (CRC) are increasing. The treatment of CRC is mainly surgical resection, and the standard treatment of metastatic colorectal cancer is Oxaliplatin chemotherapy, which is mainly a platinum agent (Alkylating… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Experimental Study Designs
- What is being tested?
- Combined Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with colon cancer, were getting chemotherapeutic drugs with oxaliplatin.
Who cannot join
- bone metastasis, lower extremity lymphedema, cognitive dysfunction, musculoskeletal problems,and diabetic.
About this study
Official title: Quality Association
Objective:
Cancer is one of the biggest global health threats. The incidence and mortality of colorectal cancer (CRC) are increasing. The treatment of CRC is mainly surgical resection, and the standard treatment of metastatic colorectal cancer is Oxaliplatin chemotherapy, which is mainly a platinum agent (Alkylating agent). Oxaliplatin can exert its anti-cancer therapeutic effect by binding to cell DNA, and become toxic to neurons, damaging large and small fibers outside the brain and spinal cord. Causes peripheral neuropathy, which seriously affects the quality of life of patients. The purpose to develop the interventional and investigate intervention by exercise program of CRC patients with regard to the improvement effect of peripheral neuropathy, fatigue and quality of life during the treatment.
Read more
Methods:
Experimental study designs were used, and samples were taken from a regional teaching hospital. The control group received routine care and maintenance of general daily activities; the experimental group received routine care and maintenance of general daily activities, and also received combined exercises, balance training and resistance exercises twice a week, 60 minutes each time, plus weekly 5 walking exercises, 30 minutes each time, for a total of 12 weeks, of which the exercise training during chemotherapy and hospitalization is performed under the supervision of the investigator, and 1 balance training and resistance exercise are performed for 60 minutes each time to ensure that the patient performs. The correctness and safety of exercises, and balance training and resistance exercises in combination with the home style. During the home exercises, the researchers will give weekly telephone interviews to understand the patient's exercise status, and indeed achieve the balance training and resistance exercises twice a week. All measurement tools and methods are implemented in accordance with consistent standard operations. The control group took pre-tests when the case was closed, without interventional measures, but also performed post-tests in the same way as the experimental group at 6 weeks, 8 weeks, 10 weeks, and 12 weeks in the interventional experimental group.
- Conditions
- Experimental Study Designs
- Being tested
- Combined Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined ExercisesBehavioural
Combined Exercises
| Study group | Role | What they receive |
|---|---|---|
| Combined Exercises on Symptoms of CIPN, Fatigue, and Quality of Life in Colon Cancer Patients | Experimental | The control group received routine care and maintenance of general daily activities; the experimental group received routine care and maintenance of general daily activities, and also received combined exercises Receives: Behavioral: Combined Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT/GOG
FACT/GOG-CIPN
Measured: 12 weeks
EORTC QLQ-C30
qulity of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Experimental Study DesignsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chi Mei Medical Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong-Chi Chiu, Chi Mei Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136573
- Sponsor's protocol ID
- Chi Mei
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Association
- ClinicalTrials.gov ID
- NCT05136573
- Acronym / sponsor ID
- Chi Mei
- Conditions
- Experimental Study Designs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chi Mei Medical HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Nov 2021 (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.
Objective:
Cancer is one of the biggest global health threats. The incidence and mortality of colorectal cancer (CRC) are increasing. The treatment of CRC is mainly surgical resection, and the standard treatment of metastatic colorectal cancer is Oxaliplatin chemotherapy, which is mainly a platinum agent (Alkylating agent). Oxaliplatin can exert its anti-cancer therapeutic effect by binding to cell DNA, and become toxic to neurons, damaging large and small fibers outside the brain and spinal cord. Causes peripheral neuropathy, which seriously affects the quality of life of patients. The purpose to develop the interventional and investigate intervention by exercise program of CRC patients with regard to the improvement effect of peripheral neuropathy, fatigue and quality of life during the treatment.
Methods:
Experimental study designs were used, and samples were taken from a regional teaching hospital. The control group received routine care and maintenance of general daily activities; the experimental group received routine care and maintenance of general daily activities, and also received combined exercises, balance training and resistance exercises twice a week, 60 minutes each time, plus weekly 5 walking exercises, 30 minutes each time, for a total of 12 weeks, of which the exercise training during chemotherapy and hospitalization is performed under the supervision of the investigator, and 1 balance training and resistance exercise are performed for 60 minutes each time to ensure that the patient performs. The correctness and safety of exercises, and balance training and resistance exercises in combination with the home style. During the home exercises, the researchers will give weekly telephone interviews to understand the patient's exercise status, and indeed achieve the balance training and resistance exercises twice a week. All measurement tools and methods are implemented in accordance with consistent standard operations. The control group took pre-tests when the case was closed, without interventional measures, but also performed post-tests in the same way as the experimental group at 6 weeks, 8 weeks, 10 weeks, and 12 weeks in the interventional experimental group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Exercises on Symptoms of CIPN, Fatigue, and Quality of Life in Colon Cancer Patients | Experimental | Behavioral: Combined ExercisesThe control group received routine care and maintenance of general daily activities; the experimental group received routine care and maintenance of general daily activities, and also received combined exercises |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with colon cancer, were getting chemotherapeutic drugs with oxaliplatin.
Key exclusion criteria (1 listed)
- bone metastasis, lower extremity lymphedema, cognitive dysfunction, musculoskeletal problems,and diabetic.
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 |
|---|---|---|
| Combined ExercisesCombined Exercises | Behavioural | Combined Exercises on Symptoms of CIPN, Fatigue, and Quality of Life in Colon Cancer Patients |
Primary outcome
FACT/GOG
Time frame: 12 weeks
FACT/GOG-CIPN
EORTC QLQ-C30
Time frame: 12 weeks
qulity of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Exercises in people with Experimental Study Designs, run by Chi Mei Medical Hospital.
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 1 inclusion and 1 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 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
FACT/GOG (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 29 Nov 2021.