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Trial Title:
Self-Management Support for Lung Cancer Patients With Cachexia
NCT ID:
NCT05731076
Condition:
Cachexia-Anorexia Syndrome
Conditions: Official terms:
Wasting Syndrome
Syndrome
Anorexia
Cachexia
Conditions: Keywords:
cancer cachexia syndrome
exercise
nutrition
muscle endurance
body mass index
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
Self-management support nutrition and exercise intervention
Description:
Provide information about different home exercise type(walking, strength training,
flexibility training), nutrition knowledge to maintain or improve cancer cachexia
syndrome.
Arm group label:
Self-management support nutrition and exercise group
Summary:
The goal of this randomized clinical trial is to test the efficacy of self-management
support based exercise combine nutrition intervention in lung cancer patient with cancer
cachexia anorexia syndrome . The main question it aims to answer is:
• Would exercise combine nutrition intervention improve lung cancer patients' nutrition
status? Participants will make custom exercise plan and eat enough protein food after
self-management support based education.
And there is a comparison group: Researchers will compare comparison group to see
nutrition status who receive routine health education.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosed lung cancer(ICD-10 code: C33-C34)
2. Body weight loss: body weight loss 2% before recruitment 2 months or body weight
loss 5% before recruitment 6months.
3. Physician judged may do home exercise without supervisor.
4. Has smart phone and agree to use exercise associated application.
5. Agree to wear Xioami smart band as long as passible.
6. Conscious clear and communication.
7. Eastern Cooperative Oncology Group (ECOG) 0-1.
Exclusion Criteria:
1. Participants with cardiovascular disease can't exercise without supervisor.
2. Diabetes Mellitus with blood sugar poor control.
3. Chronic obstructive pulmonary disease with dyspnea on exertion.
4. Platelets < 50000mm3 due to disease or treatment.
5. Hemoglobin <10mg/dl.
6. Recently stumble, severe pain, cognitive and behavior change.
7. Suspect or diagnosed brain metastasis.
8. Suspect or diagnosed bone metastasis.
9. Receive Nasogastric tube feeding or parenteral nutrition.
10. Physician judged can't do home exercise.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yuanlin Christian Hospital
Address:
City:
Changhua
Zip:
51052
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Li Chun Chang, Master
Phone:
+8868381456
Email:
1520186@cch.org.tw
Investigator:
Last name:
Tzu Fang Chen, Master
Email:
Principal Investigator
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11219
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Li Hwa Lin, Doctor
Phone:
+886228757232
Email:
Ihlin@vghtpe.gov.tw
Investigator:
Last name:
Tzu Fnag Chen, Master
Email:
Principal Investigator
Start date:
January 20, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Changhua Christian Hospital
Agency class:
Other
Source:
Changhua Christian Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05731076
