Self-Management Support for Lung Cancer Patients With Cachexia

NCT05731076 | Enrolling By Invitation

• 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 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.

Conditions

Cachexia-Anorexia Syndrome

Keywords

cancer cachexia syndrome; exercise; nutrition; muscle endurance; body mass index

Outcome Measures

Primary Outcomes (4)

• Change form Minimal Nutrition Assessment(MNA) at 12 weeks

  The MNA consists of 18 self- reported questions. Each question has different score and marked near the answer. The first part of MNA is six questions about ingestion, weight loss, current mobility, an acute illness or major stress, a neuropsychological problem, and a decrease in body mass index. The second part evaluates living arrangements, the presence of polypharmacy or pressure ulcers, the number of full meals eaten daily, the amount and frequency of specific foods and fluids, and the mode of feeding. The patient reports nutritional and health status, and the practitioner determines weight and height (to calculate BMI), and mid-arm and mid-calf circumferences. The maximal score is 30, score \>23.5 means well-nourished, 17\~23.5 means risk of malnutrition, \< 17 means malnutrition.

  Before allocation and after intervention 8 and 12 weeks.

• Change from body weight at 12weeks

  The body wight will be detected by OMRON HBF-375. Data record in kilograms and after the first decimal place.

  Before allocation and after intervention 8 and 12 weeks.

• Change from body fat mass at 12weeks

  The body fat mass will be detected by OMRON HBF-375. Data record with percentage and after the first decimal place.

  Before allocation and after intervention 8 and 12 weeks.

• Change from muscle mass at 12weeks

  The muscle mass will be detected by OMRON HBF-375. Data record with percentage and after the first decimal place.

  Before allocation and after intervention 8 and 12 weeks.

Secondary Outcomes (7)

• 30 second arm curl test

  Before allocation and after intervention 8 and 12 weeks.

• 30 second chair-stand test

  Before allocation and after intervention 8 and 12 weeks.

• Six-minute walking test

  Before allocation and after intervention 8 and 12 weeks.

• Functional Assessment of Cancer Therapy- Lung (FACT-L)

  Before allocation and after intervention 12 weeks.

• Cancer anorexia-cachexia syndrome nutrition knowledge scale

  Before allocation and after intervention 12 weeks.

Study Arms (2)

Self-management support nutrition and exercise group

EXPERIMENTAL

Educate how to plain regular exercise and eat enough protein diet with self-management support.

Behavioral: Self-management support nutrition and exercise intervention

Routine health education group

NO INTERVENTION

Routine health education.

Interventions

Self-management support nutrition and exercise intervention BEHAVIORAL

Provide information about different home exercise type(walking, strength training, flexibility training), nutrition knowledge to maintain or improve cancer cachexia syndrome.

Self-management support nutrition and exercise group

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

Study Sites (2)

Yuanlin 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

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Li Chun Chang, Master

  Yuanlin Christian hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

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, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)