UMIN-ICDS Clinical Trial

Public title

Effect of body position exchange on dyspnea associated with single-sided pleural effusion in cancer patients: A pilot randomized, crossover, controlled trial

Acronym

Effect of body position exchange on dyspnea associated with single-sided pleural effusion in cancer patients: A pilot randomized, crossover, controlled trial

Scientific Title

Effect of body position exchange on dyspnea associated with single-sided pleural effusion in cancer patients: A pilot randomized, crossover, controlled trial

Scientific Title:Acronym

Effect of body position exchange on dyspnea associated with single-sided pleural effusion in cancer patients: A pilot randomized, crossover, controlled trial

Region

Japan

Condition

Cancer

Classification by specialty

Nursing

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Confirmation of the following: (1) Prospect of efficacy for dyspnea, (2) Completion of the study

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) Difference in dyspnea NRS before and after comparison between the healthy side lying position and the sick side lying position

Key secondary outcomes

1) Number and percentage of patients who completed each intervention
2) Percentage of cases in which the dyspnea NRS decreased by 1 or more with each intervention.
3) Whether the patient felt that each intervention relieved dyspnea or not.
4) Percentage of patients who responded when asked which intervention was better, the healthy side lying position or the sick side lying position.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

1) The patient is placed in supine rest for 5 minutes. The baseline (Ti0) will be set at that point, and the dyspnea NRS will be measured. The bed angle should be between 0 and 45 degrees.
2) The patient is placed in a supine position on the healthy side with the assistance of one or more medical personnel and allowed to rest for 5 minutes. The dyspnea NRS is measured at Ti1.
3) After 5 minutes of rest in the healthy side supine position, the patient is changed to the supine position with the assistance of one or more medical personnel.
4) During the recovery period, the dyspnea NRS is measured every 15 minutes at 15 minutes (Ti15), 30 minutes (Ti30), 45 minutes (Ti45), and 60 minutes (Ti60) after the intervention, and the patient is observed for up to 60 minutes until the dyspnea NRS returns to the baseline (Ti0) level.
5) Perform the intervention in the sick side supine position and measure the dyspnea NRS.

Interventions/Control_2

1) The patient is placed in supine rest for 5 minutes. The baseline (Ti0) will be set at that point, and the dyspnea NRS will be measured. The bed angle should be between 0 and 45 degrees.
2) The patient is placed in a supine position on the scik side with the assistance of one or more medical personnel and allowed to rest for 5 minutes. The dyspnea NRS is measured at Ti1.
3) After 5 minutes of rest in the healthy side supine position, the patient is changed to the supine position with the assistance of one or more medical personnel.
4) During the recovery period, the dyspnea NRS is measured every 15 minutes at 15 minutes (Ti15), 30 minutes (Ti30), 45 minutes (Ti45), and 60 minutes (Ti60) after the intervention, and the patient is observed for up to 60 minutes until the dyspnea NRS returns to the baseline (Ti0) level.
5) Perform the intervention in the healthy side supine position and measure the dyspnea NRS.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with cancer who have given consent to participate in this study
2)Age greater than or equal to 18 years
3)Dyspnea NRS greater than or equal to 3
4)Pleural effusion more than or uqual to 1/3 on one side on standing or seated chest radiographs or CT images taken within 2 weeks prior to enrollment
5)Hb greater than or uqual to 6g/dL on the most recent blood test within 2 weeks prior to enrollment
6)SpO2 greater than or equal to 90% (oxygen can be administered)
7)Patient has clear consciousness, no cognitive impairment, and can read, write, and communicate in Japanese.

Key exclusion criteria

1)Patients who have undergone lung resection surgery in the past
2)Patients with more than 1/3 of chest effusion bilaterally on the most recent standing or sitting chest radiographs.
3)performing opioid rescue more than 9 times a day
4)Patients who have undergone any treatment or procedure (e.g., pleurodesis, blood transfusion) since radiography or CT scan and blood test 2 weeks prior to enrollment that would affect the data
5)Patients whose disease, medical condition, or symptoms may be aggravated by the positioning of the body
6)Other patients deemed inappropriate by the physician in charge for this study.

Target sample size

10

Name of lead principal investigator

1st name	Kako
Middle name
Last name	Jun

Organization

Mie University

Division name

Graduate School of Medicine

Zip code

514-8507

Address

2-174 Edobashi, Tsu City, Mie

TEL

059-231-5091

Email

jkako@med.mi-eu.ac.jp

Name of contact person

1st name	Kako
Middle name
Last name	Jun

Organization

Mie Mie University

Division name

Graduate School of Medicine

Zip code

514-8507

Address

2-174 Edobashi, Tsu City, Mie

TEL

059-231-5091

Homepage URL

Email

jkako@med.mie-u.ac.jp

Institute

Mie University

Institute

Department

Personal name

Organization

JSPS KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

NHO Kinki Chuo Chest Medical Center

Address

1180 Nagasone-cho, Kita-ku, Sakai, Osaka

Tel

072-252-3021

Email

oguni.shun.fp@mail.hosp.go.jp

Secondary IDs

YES

Study ID_1

2023-68

Org. issuing International ID_1

NHO Kinki Chuo Chest Medical Center

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

10

Month

31

Day

Date of IRB

2023

Year

10

Month

31

Day

Anticipated trial start date

2023

Year

12

Month

01

Day

Last follow-up date

2025

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

27

Day

Last modified on

2024

Year

03

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060378