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Cachexia-Anorexia SyndromeNCT05731076

Self-Management Support for Lung Cancer Patients With Cachexia

A study testing Self-management support nutrition and exercise intervention in people with Cachexia-Anorexia Syndrome and Lung Neoplasm Malignant, run by Changhua Christian Hospital at 2 sites in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Self-management support nutrition and exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
2 sitesTaiwan
Study dates
20 Jan 2023to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed lung cancer(ICD-10 code: C33-C34)
  • Body weight loss: body weight loss 2% before recruitment 2 months or body weight loss 5% before recruitment 6months.
  • Physician judged may do home exercise without supervisor.
  • Has smart phone and agree to use exercise associated application.
  • Agree to wear Xioami smart band as long as passible.
  • Conscious clear and communication.
  • Eastern Cooperative Oncology Group (ECOG) 0-1.

Who cannot join

  • Participants with cardiovascular disease can't exercise without supervisor.
  • Diabetes Mellitus with blood sugar poor control.
  • Chronic obstructive pulmonary disease with dyspnea on exertion.
  • Platelets < 50000mm3 due to disease or treatment.
  • Hemoglobin <10mg/dl.
  • Recently stumble, severe pain, cognitive and behavior change.
Show all 10Show fewer
  • Suspect or diagnosed brain metastasis.
  • Suspect or diagnosed bone metastasis.
  • Receive Nasogastric tube feeding or parenteral nutrition.
  • Physician judged can't do home exercise.

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Changhua Christian Hospital

    Changhua, Changhua, 51052

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11219

Other trials in Taiwan

About this study

Official title: Efficacy of Self-Management Support on Nutritional Status in Lung Cancer Patients With Cancer Cachexia Syndrome: A Randomized Clinical Trail

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.

Read more

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.

Being tested
Self-management support nutrition and exercise intervention
Keywords
cancer cachexia syndrome, exercise, nutrition, muscle endurance, body mass index, lung cancer, self-management support
Medical subject headings
Lung Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-management support nutrition and exercise interventionBehavioural

    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.

Study groups in NCT05731076
Study groupRoleWhat they receive
Combined Exercise and Nutrition Self-management Support ProgramExperimentalParticipants receive a 12-week multimodal intervention. This includes personalized exercise prescriptions (aerobic, resistance, and flexibility training) guided by wearable technology and structured nutritional counseling focused on adequate protein intake (e.g., 1.2 g/kg/day). All activities are supported by a self-management behavioral framework to enhance adherence. In addition, both arms receive baseline cancer care from hospital case managers to ensure ethical standards of care are met.
Receives: Behavioral: Self-management support nutrition and exercise intervention
Routine health education groupNo interventionParticipants will receive standard of care provided by cancer case managers, including education on medication adherence, symptom/side-effect management, and nutritional supplement trials as needed. To maintain study blinding, participants in this group will also wear Xiaomi smart bands and undergo the same assessment schedule (Baseline, Week 8, Week 12) without the additional self-management support program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Mini Nutrition Assessment(MNA)

    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.

    Measured: baseline, Week 8, Week 12.

Secondary outcomes (11)

  1. Feasibility of the self-management support program

    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.

    Measured: Week 12

  2. Change from balseline in Body Mass Index(BMI)

    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.

    Measured: Baseline, Week 8, Week 12

  3. Change from baseline in skeletal muscle mass

    Measured using Bioelectrical Impedance Analysis (BIA) with the InBodyDial H20 device. Data are recorded in percentage (%) and rounded to one decimal place.

    Measured: Baseline, Week 8, Week 12

  4. Change from basleline body fat mass at 12weeks

    The body fat mass will be detected by InBodyDial H20. Data record with percentage and after the first decimal place.

    Measured: Baseline, Week 8, Week 12

  5. Change from Baseline in Upper Body Muscle Endurance (30-Second Arm Curl Test)

    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.

    Measured: Baseline, Week 8, Week 12

  6. Change from Baseline in Lower Body Muscle Strength (30-Second Chair-Stand Test)

    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.

    Measured: Baseline, Week 8, Week 12

  7. Change from Baseline in cardiopulmonary function (6-Minute Walk Test)

    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.

    Measured: Baseline, Week 8, Week 12

  8. Change from basline in quality of life (FACT-L)

    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."

    Measured: Baseline, Week 12

  9. Change from Baseline in Cancer anorexia-cachexia syndrome nutrition knowledge (CACSNKQ)

    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.

    Measured: Baseline, Week 12

  10. Change from baseline in dietary intake (24 hours dietary recall)

    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.

    Measured: Baseline, Week 8, Week12

  11. Change from Baseline in amount of exercise

    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.

    Measured: Baseline to Week 8, and Week 8 to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start20 Jan 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731076
Sponsor's protocol ID
220582
Status last verified
May 2026
First submitted
23 Jan 2023
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to ethical restrictions and the terms of the informed consent form, individual participant data will not be shared with third parties.

Publications

  • Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.

    PubMed 21296615

  • Anderson LJ, Albrecht ED, Garcia JM. Update on Management of Cancer-Related Cachexia. Curr Oncol Rep. 2017 Jan;19(1):3. doi: 10.1007/s11912-017-0562-0.

    PubMed 28138933

  • Ozaki H, Nakagata T, Yoshihara T, Kitada T, Natsume T, Ishihara Y, Deng P, Kobayashi H, Machida S, Naito H. Effects of Progressive Walking and Stair-Climbing Training Program on Muscle Size and Strength of the Lower Body in Untrained Older Adults. J Sports Sci Med. 2019 Nov 19;18(4):722-728. eCollection 2019 Dec.

    PubMed 31827357

  • Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.

    PubMed 33946039

  • Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

    PubMed 31626055

  • Peddle-McIntyre CJ, Singh F, Thomas R, Newton RU, Galvao DA, Cavalheri V. Exercise training for advanced lung cancer. Cochrane Database Syst Rev. 2019 Feb 11;2(2):CD012685. doi: 10.1002/14651858.CD012685.pub2.

    PubMed 30741408

  • Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.

    PubMed 27637832

  • Schreiber M, Bucher T, Collins CE, Dohle S. The Multiple Food Test: Development and validation of a new tool to measure food choice and applied nutrition knowledge. Appetite. 2020 Jul 1;150:104647. doi: 10.1016/j.appet.2020.104647. Epub 2020 Feb 29.

    PubMed 32119883

Questions about this trial

What is this clinical trial studying?

A study testing Self-management support nutrition and exercise intervention in people with Cachexia-Anorexia Syndrome and Lung Neoplasm Malignant, run by Changhua Christian Hospital at 2 sites 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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Change from baseline Mini Nutrition Assessment(MNA) (time frame: baseline, Week 8, Week 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05731076, which also lists 8 linked publications.

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 13 May 2026.

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