UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter randomized, placebo-controlled, double-blind clinical trial assessing the effects of steroid administration on fatigue and QOL in advanced cancer patients
Acronym	Palliative medicine steroid intervention quality of life trial (PASQol)
Scientific Title	Multicenter randomized, placebo-controlled, double-blind clinical trial assessing the effects of steroid administration on fatigue and QOL in advanced cancer patients
Scientific Title:Acronym	Palliative medicine steroid intervention quality of life trial (PASQol)
Region	Japan

Condition
Condition	Cancer
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The effectiveness of oral steroid administration (2 mg betamethasone, twice a day, total of 4 mg a day) in alleviating fatigue will be assessed in advanced cancer patients with a performance status 2 or 3.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fatigue score of EORTC QLQ-C15-PAL
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral steroid administration 2 mg betamethasone, twice a day, total of 4 mg a day during a week.
Interventions/Control_2	Oral placebo capsule administration twice a day during a week.
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	89 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) The patient is diagnosed with stage 4 cancer, in which surgery aimed at complete recovery is impossible, and a decision has been made to prioritize palliative care over cancer treatment with the aim of maintaining/improving QOL. (2) Prognosis of the cancer has been judged by two members of the medical team to be approximately 4-8 weeks. The two members must have a good understanding of the patient's symptoms and include at least one physician. (3) The age when informed consent was obtained is between 20 and 89 years. (4) During the examination, the patient answered "quite a bit" or"very much"to at least one of the 3 questions below, from among the following response options: "not at all," "a little," "quite a bit," and "very much." 1) Have you felt weak? 2) Were you tired? (5) The ECOG PS score was 2 or 3. (6) Oral intake of the test drug (capsule) is possible. (7) Written informed consent to participate in the study has been obtained directly from the patient and the family.
Key exclusion criteria	(1) The patient was administered a steroid orally or by injection 1 week or less before enrollment. (2) The patient was administered a synthetic progestin 4 weeks or less before enrollment. (3) The patient had surgery 4 weeks or less before the time of enrollment. (4) The patient was undergoing radiation therapy at the time of enrollment. (5) The patient had chemotherapy 4 weeks or less before enrollment. Alternatively, it has been 4 weeks or less after the patient completed chemotherapy. (6) The patient has a prior history of diabetes that involves drug treatment. (7) The patient clearly has an infectious disease complication. (8) The patient has a peptic ulcer as a complication that involves drug treatment. (9) The patient has a mental disorder (including delirium) related to cognitive function. (10) The patient has contraindications to betamethasone tablets that are listed in the package insert. (11) For any other reason, the patient is judged by the physician in charge to be inappropriate as a subject in the present study.
Target sample size	210

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kikuko Miyazaki
Organization	Kyoto University
Division name	School of Public Health, Department of Health Informatics
Zip code
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, 6068501 Kyoto, Japan
TEL	075-753-9477
Email	miyazaki@hi.med.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kikuko Miyazaki
Organization	Kyoto University
Division name	School of Public Health, Department of Helath Informatics
Zip code
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, 6068501 Kyoto, Japan
TEL	075-753-9477
Homepage URL
Email	miyazaki@hi.med.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University, School of Public Health
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

京都大学医学部附属病院（京都府） 淀川キリスト教病院病院（大阪府） 横浜市立大学附属市民総合医療センター（神奈川県） 市立長浜病院（滋賀県） 横浜市立市民病院（神奈川県） 東邦大学医療センター　大橋病院（東京都） 高槻赤十字病院（大阪府） 星ヶ丘医療センター（大阪府） 熊本大学医学部附属病院（熊本県） 日本バプテスト病院（京都府） 東海中央病院（岐阜県） 京都民医連中央病院（京都府） 東京医科歯科大学医学部附属病院（東京都） 鈴木内科医院（東京都） 国立病院機構近畿中央胸部疾患センター（大阪府） 京都市立病院（京都府） 岡山大学病院（岡山県） 京都岡本記念病院（京都府） 三菱京都病院（京都府） 京都医療センター（京都府） 市立岸和田市民病院（大阪府） ももたろう往診クリニック（岡山県） 関西電力病院（大阪府） かえでの風クリニック（東京都） 北野病院（大阪府） 岡山赤十字病院（岡山県） 渡辺緩和ケア・在宅クリニック（京都府）

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 30 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	No longer recruiting
Date of protocol fixation	2014 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 17 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	2013 Year 09 Month 30 Day
Last modified on	2019 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013915

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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