Self-Management Support for Lung Cancer Patients With Cachexia

NCT05731076 | Active Not Recruiting

• 1 other identifier: 220582
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Neoplasm Malignant; Cachexia-Anorexia Syndrome

Keywords

cancer cachexia syndrome; exercise; nutrition; muscle endurance; body mass index; lung cancer; self-management support

Outcome Measures

Primary Outcomes (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.

  baseline, Week 8, Week 12.

Secondary Outcomes (11)

• Feasibility of the self-management support program

  Week 12

• Change from balseline in Body Mass Index(BMI)

  Baseline, Week 8, Week 12

• Change from baseline in skeletal muscle mass

  Baseline, Week 8, Week 12

• Change from basleline body fat mass at 12weeks

  Baseline, Week 8, Week 12

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

  Baseline, Week 8, Week 12

Study Arms (2)

Combined Exercise and Nutrition Self-management Support Program

EXPERIMENTAL

Participants 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.

Behavioral: Self-management support nutrition and exercise intervention

Routine health education group

NO INTERVENTION

Participants 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.

Interventions

Self-management support nutrition and exercise intervention BEHAVIORAL

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.

Combined Exercise and Nutrition Self-management Support Program

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Suspect or diagnosed brain metastasis.
• Suspect or diagnosed bone metastasis.
• Receive Nasogastric tube feeding or parenteral nutrition.
• Physician judged can't do home exercise.

Sponsors & Collaborators

• Changhua Christian Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• National Taipei University of Nursing and Health Sciences: collaborator

Study Sites (2)

Changhua Christian Hospital

Changhua, Changhua, 51052, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taipei, 11219, Taiwan

Location

Related Publications (8)

• 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.

  PMID: 21296615 BACKGROUND

• 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.

  PMID: 28138933 BACKGROUND

• 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.

  PMID: 31827357 BACKGROUND

• 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.

  PMID: 33946039 RESULT

• 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.

  PMID: 31626055 RESULT

• 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.

  PMID: 30741408 RESULT

• 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.

  PMID: 27637832 RESULT

• 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.

  PMID: 32119883 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Li Chun Chang, Master

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

• Tsae Jyy Wang, PhD

  National Taipei University of Nursing and Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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．
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of nurse practitioner

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 16, 2023
• Study Start: January 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)