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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005854
Receipt No. R000006916
Scientific Title Phase 1 Trial of Tris-hydroxymethyl aminomethane (THAM) Infusion on the dyspnea associated with Cancer
Date of disclosure of the study information 2011/07/01
Last modified on 2013/07/05

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Basic information
Public title Phase 1 Trial of Tris-hydroxymethyl aminomethane (THAM) Infusion on the dyspnea associated with Cancer
Acronym Phase 1 Trial of Tris-hydroxymethyl aminomethane (THAM) Infusion on the dyspnea associated with Cancer
Scientific Title Phase 1 Trial of Tris-hydroxymethyl aminomethane (THAM) Infusion on the dyspnea associated with Cancer
Scientific Title:Acronym Phase 1 Trial of Tris-hydroxymethyl aminomethane (THAM) Infusion 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 validate the safety of THAM infusion on dyspnea in patients with cancer and to determine the recommended dose of THAM
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Respiratory depression, hypotention, hypoglycemia and adverse effects greater than grade 3 on CTCAE ver 4.0
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 THAM infusion at a rate of 0.2ml/kg/min for 20 min or 40 min
Interventions/Control_2
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, ascites, 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 THAM and opioids
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) Metabolic or respiratory acidosis
6) Severe respiratory failure or the administration of oxygen with flow rate of 10L/min or more
7) Ineligible condition for study in physician's judge
8) The change in prescription of opioids, steroids and anxiolytics within 2 days prior to study
9) The change in the chemotherapy within 7 days prior to study
10) SBP <= 90mmHg, SpO2 < 90%,
RR at rest <= 10, BS < 60
Target sample size 12

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
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization MHLW/JSPS
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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