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
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
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
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
