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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007887
Receipt No. 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

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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
Email 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
Email taku@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine
Kyorin Univercity Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009289

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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