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 |
Multicenter randomized, placebo-controlled, double-blind clinical trial assessing the effects of steroid administration on fatigue and QOL in advanced cancer patients
Palliative medicine steroid intervention quality of life trial (PASQol)
Multicenter randomized, placebo-controlled, double-blind clinical trial assessing the effects of steroid administration on fatigue and QOL in advanced cancer patients
Palliative medicine steroid intervention quality of life trial (PASQol)
Japan |
Cancer
Not applicable |
Malignancy
NO
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.
Efficacy
Confirmatory
Fatigue score of EORTC QLQ-C15-PAL
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
YES
No need to know
2
Treatment
Medicine |
Oral steroid administration 2 mg betamethasone, twice a day, total of 4 mg a day during a week.
Oral placebo capsule administration twice a day during a week.
20 | years-old | <= |
89 | years-old | >= |
Male and Female
(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.
(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.
210
1st name | Kikuko |
Middle name | |
Last name | Miyazaki |
Kyoto University
School of Public Health, Department of Health Informatics
251-0037
Yoshida Konoe-cho, Sakyo-ku, Kyoto, 6068501 Kyoto, Japan
0466367044
miy@plum.ocn.ne.jp
1st name | Kikuko |
Middle name | |
Last name | Miyazaki |
Kyoto University
School of Public Health, Department of Helath Informatics
606-8501
Yoshida Konoe-cho, Sakyo-ku, Kyoto, 6068501 Kyoto, Japan
075-753-9477
miy@plum.ocn.ne.jp
Kyoto University, School of Public Health
Japan Society for the Promotion of Science (JSPS)
Japanese Governmental office
Japan
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501 JAPAN
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
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)
2013 | Year | 09 | Month | 30 | Day |
hi.med.kyoto-u.ac.jp/HP_PASQol_0715.pdf
Unpublished
80
Delay expected |
Because it has not yet been accepted by the journal.
No longer recruiting
2014 | Year | 06 | Month | 17 | Day |
2014 | Year | 06 | Month | 17 | Day |
2014 | Year | 06 | Month | 17 | Day |
2019 | Year | 06 | Month | 16 | Day |
2013 | Year | 09 | Month | 30 | Day |
2022 | Year | 10 | Month | 10 | Day |
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 |