UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011913
Receipt number R000013915
Scientific Title Multicenter randomized, placebo-controlled, double-blind clinical trial assessing the effects of steroid administration on fatigue and QOL in advanced cancer patients
Date of disclosure of the study information 2013/09/30
Last modified on 2022/10/10 09:23:09

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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 Kikuko
Middle name
Last name Miyazaki

Organization

Kyoto University

Division name

School of Public Health, Department of Health Informatics

Zip code

251-0037

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto, 6068501 Kyoto, Japan

TEL

0466367044

Email

miy@plum.ocn.ne.jp


Public contact

Name of contact person

1st name Kikuko
Middle name
Last name Miyazaki

Organization

Kyoto University

Division name

School of Public Health, Department of Helath Informatics

Zip code

606-8501

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto, 6068501 Kyoto, Japan

TEL

075-753-9477

Homepage URL


Email

miy@plum.ocn.ne.jp


Sponsor or person

Institute

Kyoto University, School of Public Health

Institute

Department

Personal name



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

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501 JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp


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

hi.med.kyoto-u.ac.jp/HP_PASQol_0715.pdf

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

80

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Because it has not yet been accepted by the journal.

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

2014 Year 06 Month 17 Day

Anticipated trial start date

2014 Year 06 Month 17 Day

Last follow-up date

2019 Year 06 Month 16 Day

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

2022 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013915


Research Plan
Registered date File name
2022/07/22 PASQol Protcol_0715.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2022/07/22 PASQol_Data21Dec21.csv