UMIN-CTR Clinical Trial

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

Dyspnea associated with Cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Chest surgery
Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Respiratory depression, hypotention, hypoglycemia and adverse effects greater than grade 3 on CTCAE ver 4.0

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Chiba University Hospital

Institute

Department

Personal name

Organization

MHLW/JSPS

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

07

Month

01

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

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 related 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=R000006916