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Self-Management Support for Lung Cancer Patients With Cachexia

Primary Purpose

Cachexia-Anorexia Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Self-management support nutrition and exercise intervention

About this trial

This is an interventional treatment trial for Cachexia-Anorexia Syndrome focused on measuring cancer cachexia syndrome, exercise, nutrition, muscle endurance, body mass index

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

Yuanlin Christian HospitalRecruiting
Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-management support nutrition and exercise group

Routine health education group

Arm Description

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

Routine health education.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

30 second arm curl test

Used to test muscle endurance of upper extremities. Let the participant sit on a chair and holding the dumbbell(female 5 pound; male 8 pound), then repeated curl his/her elbow. Count how many times can the participant curl their elbow in 30 seconds. More curl times means better upper endurance.

30 second chair-stand test

To test muscle endurance of lower extremities. Let the participant sit on a chair, then repeated stand up and sit. Count how many times can he/she curl his/ her elbow in 30 seconds. The more frequency the better lower limb endurance.

Six-minute walking 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.

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

FACT-L could determine quality of life in lung cancer patients. It content 5 dimensions, physical well-being 7items, social/family well-being 7items, emotional well-being 6items, functional well-being 7 items, and Lung cancer sub-scale 9 items. It used Likert 5 point and the score ranged from 0 to 144. The higher score means better quality of life.

Cancer anorexia-cachexia syndrome nutrition knowledge scale

Cancer anorexia-cachexia syndrome nutrition knowledge scale was developed to test cancer patients' cachexia nutrition knowledge. It content the knowing of cancer anorexia-cachexia syndrome(7 items), the technology on choose food(15 items), and anorexia management(7 items). The items are multiple choice but only one correct answer. The score ranged from 0 to 29, the higher score means the participant has better nutrition knowledge to against cancer anorexia-cachexia syndrome.

24 hours dietary recall

To understand participants' nutrition intake before and after intervention. Let participants recall their last 24 hours diet by interview, include dish name, amount, cooking method, and nutrition supply. Collected data will be translated to calories, protein, fat, and carbohydrate by a nutritionist, and then it will be continues variable for analysis.

Change from amount of exercise at 12 weeks

Measure amount of exercise by Xioami smart band. It is a wearable device, can record exercise, include time, duration, and heart rate...etc. Let the participant wear the smart band all day if passible. Collect walking distance, exercise date, exercise mode, duration by latest Xioami published application. Collected data will be continuous variable and analyzed.

Full Information

NCT ID

NCT05731076

First Posted

January 23, 2023

Last Updated

February 15, 2023

Sponsor

Changhua Christian Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05731076

Brief Title

Self-Management Support for Lung Cancer Patients With Cachexia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2023 (Actual)

Primary Completion Date

August 31, 2024 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhua Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cachexia-Anorexia Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Self-management support nutrition and exercise group

Arm Type

Experimental

Arm Description

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

Arm Title

Routine health education group

Arm Type

No Intervention

Arm Description

Routine health education.

Intervention Type

Behavioral

Intervention Name(s)

Self-management support nutrition and exercise intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Change form Minimal Nutrition Assessment(MNA) at 12 weeks

Description

Time Frame

Before allocation and after intervention 8 and 12 weeks.

Title

Change from body weight at 12weeks

Description

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

Time Frame

Before allocation and after intervention 8 and 12 weeks.

Title

Change from body fat mass at 12weeks

Description

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

Time Frame

Before allocation and after intervention 8 and 12 weeks.

Title

Change from muscle mass at 12weeks

Description

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

Time Frame

Before allocation and after intervention 8 and 12 weeks.

Secondary Outcome Measure Information:

Title

30 second arm curl test

Description

Time Frame

Before allocation and after intervention 8 and 12 weeks.

Title

30 second chair-stand test

Description

Time Frame

Before allocation and after intervention 8 and 12 weeks.

Title

Six-minute walking test

Description

Time Frame

Before allocation and after intervention 8 and 12 weeks.

Title

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

Description

Time Frame

Before allocation and after intervention 12 weeks.

Title

Cancer anorexia-cachexia syndrome nutrition knowledge scale

Description

Time Frame

Before allocation and after intervention 12 weeks.

Title

24 hours dietary recall

Description

Time Frame

Before allocation and after intervention 8 and 12 weeks.

Title

Change from amount of exercise at 12 weeks

Description

Time Frame

Collect 1~8week and 8-12 week exercise record.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Chun Chang, Master

Phone

+88648381456

1520186@cch.org.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Tzu Fang Chen, Master

Phone

+886919067955

vickie333.tw@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Chun Chang, Master

Organizational Affiliation

Yuanlin Christian hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yuanlin Christian Hospital

City

Changhua

ZIP/Postal Code

51052

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Chun Chang, Master

Phone

+8868381456

1520186@cch.org.tw

First Name & Middle Initial & Last Name & Degree

Tzu Fang Chen, Master

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11219

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Hwa Lin, Doctor

Phone

+886228757232

Ihlin@vghtpe.gov.tw

First Name & Middle Initial & Last Name & Degree

Tzu Fnag Chen, Master

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21296615

Citation

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.

Results Reference

background

PubMed Identifier

28138933

Citation

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. Erratum In: Curr Oncol Rep. 2017 Mar;19(3):22.

Results Reference

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PubMed Identifier

31827357

Citation

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.

Results Reference

background

PubMed Identifier

33946039

Citation

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.

Results Reference

result

PubMed Identifier

31626055

Citation

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.

Results Reference

result

PubMed Identifier

30741408

Citation

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.

Results Reference

result

PubMed Identifier

27637832

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

result

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Self-Management Support for Lung Cancer Patients With Cachexia

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