Cachexia-Anorexia Syndrome, Lung Neoplasm Malignant
Conditions
Keywords
cancer cachexia syndrome, exercise, nutrition, muscle endurance, body mass index, lung cancer, self-management support
Brief summary
The goal of this randomized clinical trial is to evaluate the efficacy of a self-management support program combining exercise and nutrition intervention for lung cancer patients with cancer cachexia anorexia syndrome. This study is conducted in two stages. In the first stage (Pilot Phase), the researchers aim to assess the feasibility of the intervention and its potential impact on nutritional status in 20 participants. Based on these preliminary results, the intervention protocol or supervision model may be refined for the subsequent full-scale trial. The main questions it aims to answer are: Is the combined exercise and nutrition self-management support program feasible for lung cancer patients with cachexia? Can this integrated intervention improve the nutritional status of these patients compared to routine care? Participants in the intervention group will receive self-management support-based education to develop personalized exercise plans and ensure adequate protein intake. The researchers will compare this group to a control group receiving routine health education to evaluate differences in nutritional outcomes.
Interventions
BEHAVIORALSelf-management support nutrition and exercise intervention
A structured 12-week multimodal support program. (1) Exercise: Personalized home-based aerobic, resistance, and flexibility training (at least 3 times/week, 30 min/session) monitored via Xiaomi smart bands. (2) Nutrition: Goal-oriented counseling focused on achieving a high-protein intake (e.g., 1.2-1.5 g/kg/day). (3) Self-management: Continuous support using a self-monitoring manual, wearable device feedback, and a dedicated Line@ social media platform for real-time interaction with researchers, providing counseling and symptom management support to enhance patient adherence.
Sponsors
Changhua Christian Hospital
Taipei Veterans General Hospital, Taiwan
National Taipei University of Nursing and Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
To maintain blinding, all participants are provided with wearable devices and undergo identical assessment protocols. They are informed that personalized health education will be delivered at varying intervals based on clinical results, which prevents them from distinguishing between the experimental and control intervention models．
Intervention model description
This is a two-stage, randomized supportive care trial. Stage 1 (Pilot Phase, n=20) focuses on evaluating the feasibility of the self-management support program (exercise and nutrition) in lung cancer patients with cachexia. Based on Stage 1 results, the intervention protocol may be refined to optimize adherence. Stage 2 (Main Trial) will follow to evaluate clinical efficacy. To maintain participant masking, all subjects undergo identical assessment procedures and wear smart bands, with health education delivered as a personalized service based on individual test results.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Mini Nutrition Assessment(MNA) | baseline, Week 8, Week 12. | The MNA consists of 18 self-reported questions covering ingestion, weight loss, mobility, acute illness/stress, neuropsychological problems, BMI, living arrangements, polypharmacy, skin ulcers, meal frequency, food/fluid intake, and mode of feeding. The maximal score is 30. A score \>23.5 means well-nourished, 17-23.5 means risk of malnutrition, and \<17 means malnutrition. Higher scores indicate better nutritional status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the self-management support program | Week 12 | Assessed by recruitment rate (percentage of eligible patients enrolled), retention rate (percentage of participants completing the 12-week study), and adherence to the wearable device and Line@ interaction. |
| Change from balseline in Body Mass Index(BMI) | Baseline, Week 8, Week 12 | BMI is calculated as weight in kilograms divided by the square of height in meters (kg/m\^2), measured using Bioelectrical Impedance Analysis (BIA) with the InBodyDial H20 device. Data are recorded and rounded to one decimal place. |
| Change from baseline in skeletal muscle mass | Baseline, Week 8, Week 12 | Measured using Bioelectrical Impedance Analysis (BIA) with the InBodyDial H20 device. Data are recorded in percentage (%) and rounded to one decimal place. |
| Change from basleline body fat mass at 12weeks | Baseline, Week 8, Week 12 | The body fat mass will be detected by InBodyDial H20. Data record with percentage and after the first decimal place. |
| Change from Baseline in Upper Body Muscle Endurance (30-Second Arm Curl Test) | Baseline, Week 8, Week 12 | Used to evaluate upper body muscle endurance. The participant sits on a chair with back supported and performs as many bicep curls as possible in 30 seconds using a dumbbell (5 lbs for females; 8 lbs for males). The total number of completed curls is recorded. Higher scores (more repetitions) indicate better upper body muscle endurance. |
| Change from Baseline in Lower Body Muscle Strength (30-Second Chair-Stand Test) | Baseline, Week 8, Week 12 | Used to evaluate lower body muscle strength. The participant sits in the middle of a chair with back straight and feet flat on the floor, then stands up completely and sits down repeatedly for 30 seconds. The total number of completed stands is recorded. Higher scores (more repetitions) indicate better lower body muscle strength. |
| Change from Baseline in cardiopulmonary function (6-Minute Walk Test) | Baseline, Week 8, Week 12 | Examine cardiopulmonary function in this study. Let the participant sit and rest 10 minutes before test. Check vital signs and oxygen situation for patient safety. Position the participant at the starting line, and walking back and forth along the mark on the floor. When the participant starts to walk, starts the times. Don't walk nor talk with him/ her, and count the laps attentively. Participant can walk longer distance means better cardiopulmonary function. |
| Change from basline in quality of life (FACT-L) | Baseline, Week 12 | The Functional Assessment of Cancer Therapy-Lung (FACT-L) is used to determine quality of life in lung cancer patients. It contains 5 dimensions: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and lung cancer subscale (9 items). Items are rated on a 5-point Likert scale with total scores ranging from 0 to 144. Higher scores indicate better quality of life." |
| Change from Baseline in Cancer anorexia-cachexia syndrome nutrition knowledge (CACSNKQ) | Baseline, Week 12 | The CACSNKQ is designed to assess patients' knowledge regarding cancer anorexia-cachexia syndrome. All items are multiple-choice with one correct answer. The total score ranges from 0 to 21, with higher scores indicating better nutritional knowledge and self-management ability against the syndrome. |
| Change from baseline in dietary intake (24 hours dietary recall) | Baseline, Week 8, Week12 | To assess participants' nutritional intake. A 24-hour dietary recall interview is conducted to record all food and beverage consumption (including dish names, portion sizes, and preparation methods). Data are converted into total calories (kcal) and macronutrients (protein, fat, and carbohydrates in grams) by a registered dietitian using nutritional analysis software. |
| Change from Baseline in amount of exercise | Baseline to Week 8, and Week 8 to Week 12 | Measured using the Xiaomi Smart Band and a self-management support manual. The Xiaomi Smart Band is worn daily by participants to record continuous physical activity data, including daily step count, exercise duration, walking distance, and heart rate. Additionally, participants use the self-management support manual to log the specific duration and frequency of resistance training and stretching exercises. |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORLi Chun Chang, Master
Changhua Christian Hospital
STUDY_DIRECTORTsae Jyy Wang, PhD
National Taipei University of Nursing and Health Sciences
Outcome results
None listed