UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007887 |
|---|---|
| Receipt number | R000009289 |
| Scientific Title | An Exploratory study on safety and tolerability of hydration using oral rehydration solution during cisplatin chemotherapy |
| Date of disclosure of the study information | 2012/05/08 |
| Last modified on | 2015/06/07 01:12:36 |
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Basic information
Public title
An Exploratory study on safety and tolerability of hydration using oral rehydration solution during cisplatin chemotherapy
Acronym
Safety and tolerability of hydration using oral rehydration solution during cisplatin chemotherapy(ALCT002)
Scientific Title
An Exploratory study on safety and tolerability of hydration using oral rehydration solution during cisplatin chemotherapy
Scientific Title:Acronym
Safety and tolerability of hydration using oral rehydration solution during cisplatin chemotherapy(ALCT002)
Region
| Japan |
Condition
Condition
Lung cancer patients planned to receive two or more cycles of cisplatin chemotherapy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of hydration using oral rehydration solution in comparison with the hydration using intravenous solution during cisplatin chemotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum creatinine
Key secondary outcomes
serum cystatinC
serum beta2-microglobulin
serum BUN
urine volume
urine sodium
urine NAG
urine beta2-microglobulin
creatinine clearance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
hydration using intravenous solution
(chemotherapy days 2 and 3)
Interventions/Control_2
Hydration using oral rehydration solution
(chemotherapy days 2 and 3)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with histologically or cytrologically confirmed diagnosis of lung cancer
2. Patients planned to receive two or more cycles of cisplatin chemotherapy
3. Patients aged between 20 and 74 years
4. Patients with ECOG Performance status of 0 to 2
5. Patients expected to survive longer than at least three months
6. Patients who can be treated after hospitalization
7. Patients who provide written informed consent
8. Patients who have never been treated with cisplatin previously
Key exclusion criteria
1. Patients with the serum creatinine level exceeding the upper limit of the hospital or with the estimated Ccr of 60mL/min or lower
2. Patients with intractable ascites or pleural effusion except those who have been treated by pleurodesis.
3. Patients with psychiatric disease or psychological symptom
4. Female patients of childbearing potential, pregnancy, or lactation
5. Patients with poorly controlled diabetes
6. Patients who meet the criteria specified in "contraindication" or "careful administration" in the package inserts of the intravenous solutions used in the study
7. Patients with difficulty eating or with grade 2 or higher anorexia (CTCAE 4.0)
8. Patients otherwise deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Yokoyama |
Organization
Kyorin Univercity Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
6-20-2 shinkawa,Mitaka city,Tokyo
TEL
0422-47-5511
taku@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Yokoyama |
Organization
Kyorin Univercity Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
6-20-2 shinkawa,Mitaka city,Tokyo
TEL
0422-47-5511
Homepage URL
taku@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine
Kyorin Univercity Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 05 | Month | 08 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 03 | Day |
Last modified on
| 2015 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009289
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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