Self-Management Support for Lung Cancer Patients With Cachexia

NCT ID: NCT05731076

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cachexia-Anorexia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Self-management support nutrition and exercise group

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

Group Type EXPERIMENTAL

Self-management support nutrition and exercise intervention

Intervention Type BEHAVIORAL

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

Routine health education group

Routine health education.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self-management support nutrition and exercise intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Li Chun

Head of nurse practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Chun Chang, Master

Role: PRINCIPAL_INVESTIGATOR

Yuanlin Christian hospital

Locations

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Yuanlin Christian Hospital

Changhua, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status NOT_YET_RECRUITING

Countries

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Taiwan

Central Contacts

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Li Chun Chang, Master

Role: CONTACT

+88648381456

Tzu Fang Chen, Master

Role: CONTACT

+886919067955

Facility Contacts

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Li Chun Chang, Master

Role: primary

+8868381456

Li Hwa Lin, Doctor

Role: primary

+886228757232

References

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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.

Reference Type BACKGROUND
PMID: 21296615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28138933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31827357 (View on PubMed)

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.

Reference Type RESULT
PMID: 33946039 (View on PubMed)

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.

Reference Type RESULT
PMID: 31626055 (View on PubMed)

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.

Reference Type RESULT
PMID: 30741408 (View on PubMed)

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.

Reference Type RESULT
PMID: 27637832 (View on PubMed)

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.

Reference Type RESULT
PMID: 32119883 (View on PubMed)

Other Identifiers

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220582

Identifier Type: -

Identifier Source: org_study_id

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