UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005853
Receipt number R000006915
Scientific Title Randomized Phase 2 Trial of Inhaled Furosemide on the dyspnea associated with Cancer
Date of disclosure of the study information 2011/07/01
Last modified on 2013/07/05 18:31:44

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Basic information

Public title

Randomized Phase 2 Trial of Inhaled Furosemide on the dyspnea associated with Cancer

Acronym

Randomized Phase 2 Trial of Inhaled Furosemide on the dyspnea associated with Cancer

Scientific Title

Randomized Phase 2 Trial of Inhaled Furosemide on the dyspnea associated with Cancer

Scientific Title:Acronym

Randomized Phase 2 Trial of Inhaled Furosemide on the dyspnea associated with Cancer

Region

Japan


Condition

Condition

Dyspnea associated with Cancer

Classification by specialty

Pneumology Hematology and clinical oncology Chest surgery
Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect and the safety of inhaled furosemide on dyspnea in patients with cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The worst dyspneic sensation as measured on NRS between on the previous day of the treatment and on the final day of the treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Nebulized furosemide 40mg at a time, 3 times a day on 2 consecutive days

Interventions/Control_2

Nebulized 0.9% saline 4ml at a time,
3 times a day on 2 consecutive days

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

I.The first stage
1) Age >= 20
2) Notified cancer patients
3) The patients having cancer dyspnea mainly caused by one of the following conditions: pleural effusion, primary lung tumor, metastatic lung tumor, cough, air way stenosis, and phrenic nerve paralysis, with or without chronic obstructive lung disease

II.The second stage
1) Written informed consent
2) The patients with the sensation of dyspnea, the worst score of which is 6 or more on NRS, on 2 consecutive days
3) Expected survival of more than 2 weeks
4) The patients with the sensation of dyspnea after the treatment of rapid onset oral morphine
5) PS(ECOG)1-3
6) Hospitalized patients
7) Eligible for the first stage inclusion criteria

Key exclusion criteria

I. The first stage
1) Hypersensitivity reactions to furosemide, opioids and sulfonamide derivatives
2) Severe heart failure, respiratory disease with unstable dyspnea
3) Neurological, mental impairment
with the difficulty of collecting data
4) Drug abuse, drug dependence
5) Pregnancy, lactation

II. The second stage
1) Inability to take oral rapid onset morphine
2) Pain score above 3
3) Severe hypertention(SBP >= 180mmHg or DBP >= 110mmHg)
4) Liver failure, renal failure
AST(GOT) >= 100IU/L
ALT(GPT) >= 100IU/L
T.bil >= 2.0mg/dL
eGFR <= 30 mL/hr
5) Severe respiratory failure or the administration of oxygen with flow rate of 10L/min or more
6) Ineligible condition for study in physician's judge
7) The change in prescription of opioid, steroids and anxiolytics within 2 days prior to study
8) The change in the chemotherapy within 7 days prior to study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Natsuko Nozaki-Taguchi

Organization

Chiba University Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-8-1 Inohanacho, Chuo-ku, Chiba 260-8670, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Chiba University Hospital

Division name

Department of Anesthesiology

Zip code


Address


TEL

043-226-2155

Homepage URL


Email



Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

MHLW

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2011 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2011 Year 06 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 06 Month 27 Day

Last modified on

2013 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006915


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name