Clinical trial NCT05731076: Self-Management Support for Lung Cancer Patients With Cachexia
Official title: Efficacy of Self-Management Support on Nutritional Status in Lung Cancer Patients With Cancer Cachexia Syndrome: A Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cachexia-Anorexia Syndrome
Keywords: cancer cachexia syndrome
exercise
nutrition
muscle endurance
body mass index
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Change form Minimal Nutrition Assessment(MNA) at 12 weeks
timeFrame: Before allocation and after intervention 8 and 12 weeks.
measure: Change from body weight at 12weeks
timeFrame: Before allocation and after intervention 8 and 12 weeks.
measure: Change from body fat mass at 12weeks
timeFrame: Before allocation and after intervention 8 and 12 weeks.
measure: Change from muscle mass at 12weeks
timeFrame: Before allocation and after intervention 8 and 12 weeks.
Secondary outcomes:
measure: 30 second arm curl test
timeFrame: Before allocation and after intervention 8 and 12 weeks.
measure: 30 second chair-stand test
timeFrame: Before allocation and after intervention 8 and 12 weeks.
measure: Six-minute walking test
timeFrame: Before allocation and after intervention 8 and 12 weeks.
measure: Functional Assessment of Cancer Therapy- Lung (FACT-L)
timeFrame: Before allocation and after intervention 12 weeks.
measure: Cancer anorexia-cachexia syndrome nutrition knowledge scale
timeFrame: Before allocation and after intervention 12 weeks.
measure: 24 hours dietary recall
timeFrame: Before allocation and after intervention 8 and 12 weeks.
measure: Change from amount of exercise at 12 weeks
timeFrame: Collect 1~8week and 8-12 week exercise record.
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Yuanlin Christian Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Yuanlin Christian hospital
name: Li Chun Chang, Master
role: PRINCIPAL_INVESTIGATOR
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