Clinical trial · Interventional
Self-Management Support for Lung Cancer Patients With Cachexia
Efficacy of Self-Management Support on Nutritional Status in Lung Cancer Patients With Cancer Cachexia Syndrome: A Randomized Clinical Trail
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia-Anorexia Syndrome | — | UNRESOLVED | — |
| Lung Neoplasm Malignant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-management support nutrition and exercise intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combined Exercise and Nutrition Self-management Support Program
- description
- 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.
- interventionNames
- Behavioral: Self-management support nutrition and exercise intervention
- type
- NO_INTERVENTION
- label
- Routine health education group
- description
- 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.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDFearon 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
- BACKGROUNDAnderson 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
- BACKGROUNDOzaki 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
- RESULTMuscaritoli 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
- RESULTCampbell 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
- RESULTPeddle-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.