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 | 2024/06/16 12:12:14 |
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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
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
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
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
Published
Result
URL related to results and publications
doi: 10.1016/j.jpainsymman.2024.01.037. Epub 2024 Feb 7.
Number of participants that the trial has enrolled
80
Results
We randomly assigned 41 patients to the betamethasone group and 40 patients to the placebo group. The mean difference in the EORTC-QLQ-C15-PAL fatigue subscale was -8.2 (95% CIs: -22.3, 0.0; P=0.178), and in a numerical rating scale (NRS) for fatigue was -1.2 (95% CIs: -2.5, -0.01; P=0.048), respectively. Emotional function, appetite loss, and global health were slightly better in the betamethasone group than in the placebo group.
Results date posted
| 2024 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The baseline characteristics of the betamethasone and placebo groups were almost the same, except that the age (79.7 vs. 72.4 years) and ECOG PS3 (60.6% vs. 51.4%) in the betamethasone group were slightly higher than those in the placebo group (Table 1).
Participant flow
The enrollment and assignment of participants selected from the 267 individuals screened, were randomly assigned to either the betamethasone group (n = 41) or placebo group (n = 40).
One patient in the betamethasone group did not follow the protocol. Because 7 patients in the betamethasone group and 3 patients in the placebo group withdrew due to the worsening of cancer or difficulty in oral administration, their QoL could not be evaluated at the end of the study. Therefore, 33 patients in the betamethasone group and 37 patients in the placebo group were included in the efficacy analysis.
Adverse events
The number of AEs: 12 AEs in 8 patients in the betamethasone group, and 7 AEs in 6 patients in the placebo group.
Severe AEs were observed in 4 instances in 3 patients in the betamethasone group, and 3 severe AEs in 2 patients in the placebo group.
Outcome measures
The primary endpoint was the fatigue subscale score of the EORTC QLQ-C15-PAL (at
baseline and day 7). The secondary endpoints were the numerical rating scale (NRS) score
for fatigue, subscales score for emotional function, appetite loss, and global-health of the
EORTC QLQ-C15-PAL (assessed at baseline and day 7), as well as survival time.
Plan to share IPD
IPD sharing Plan description
The data registered with UMIN Individual Case Data Repository
https://www.umin.ac.jp/icdr/index.html
Progress
Recruitment status
Main results already published
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
| 2024 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013915
