臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 28, 2018
Last modified on	Dec. 31, 2022
Trial ID	jRCTs031180068

Scientific Title	Dexamethasone for cancer-related fatigue in advanced cancer patients - multi-center phase II trial (Dex8mgPII)
Public Title	Dexamethasone for cancer-related fatigue in advanced cancer patients - multi-center phase II trial (Dex8mgPII)

Completion date	June. 30, 2020
Result actual enrolment	32
Baseline Characteristics	Age median 65.5 y.o. Male 14/32 PS 1/2/3 = 0/6/25 Cancer site: Cololectal 9, Lung 5, Esopagus 5
Participant flow	FPI: 2017.10.26 LPI: 2019.9.18
Adverse events	Gr 3-4: fatigue 3, delirium 1, hyperglycemia 1, insomnia 1
Outcome measures	Primary outcome: The change of FACIT-F subscale at day 8 was 5.2 (95%CI 0.8-10.0)(p=0.02). The lower threshold of 95%CI was below 3. Secondary outcome: The change of NRS fatigue and ACS at day 8 were -0.76 (-1.8-0.3) and 5.6 (95%CI 2.5-8.8) (p<0.001). Seven severe adverse events were occured (fatigue 3, delirium 1, hyperglycemia 1, anemia 1 and insomnia 1).
Brief summary	The efficacy and safety were evaluated by phase II clinical trial for advanced cancer patients receiving only palliative care and with moderate fatigue. The efficacy and safety were found. However, the efficacy did not achieve the preset outcomes.
Date of posting of results summaries	Dec. 31, 2022
Date of the first journal publication of results	Dec. 31, 2021
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs031180068

Contact for Scientific Queries	Name	Miura Tomofumi
	Affiliation	National Cancer Center Hospital East
	Address	Kashiwanoha 6-5-1, Kashiwa, Chiba, Japan
	Telephone	+81-4-7133-1111
	E-mail	tomiura@ncc.go.jp
Contact for Public Queries	Name	Okizaki Ayumi
	Affiliation	National Cancer Center Hospital East
	Address	Kashiwanoha 6-5-1, Kashiwa, Chiba, Japan
	Telephone	+81-4-7133-1111
	E-mail	aokizaki@east.ncc.go.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 23, 2017
Actual date of first enrollment		Oct. 26, 2017
Target sample size		32
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	supportive care
Key inclusion & exclusion criteria	Inclusion Criteria	A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue score 4 and more using NRS(0-10) 20 years and older Prognosis over 30 days No anti-cancer treatment plan Inpatient receiving palliative care Performance status 1-3 Conprehension of Japanese Provided written informed consent
	Exclusion Criteria	Patients received corticosteroid therapies within 1 week Patients received surgery within 4 week Patients received radiation therapy within 2 week Patients received anti-tumor treatment within 2 week Patients had diabetes mellitus, active infection and cognitive disorder
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		A diagnosis of advanced cancer (defined as metastatic or recurrent)
Intervention(s)		1. Dexamethasone 8mg by mouth once a day day 1-7, 4mg for day 8-14 2. Dexamethasone 6.6mg by venous injection once a day day 1-7, 3.3mg for day 8-14
Health Condition(s) Keyword		Fatigue, Cancer, Dexamethasone
Intervention(s) Keyword		Multi-center phase II trial
Health Condition(s) Code		none
Intervention(s) Code
Primary Outcome(s)		The change of FACIT-Fatigue subscale score at day 8
Secondary Outcome(s)		The change of fatigue score The proportion of achievement of individual therapeutic goal The change of symptom scores the change of performance status Patients satisfaction Adverse events

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research nd Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Cancer Center Hospital East Certified Review Board
Address	6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan, Chiba
Telephone	+81-4-7133-1111
E-Mail	ncche-irb@east.ncc.go.jp
Approval Status	Approval
Date of approval	Sept. 14, 2018

Secondary ID(s)	UMIN000028877
Issuing Authority	UMIN Clinical Trials Registry

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Dec. 31, 2022	(this page)	Changes
5	Dec. 20, 2019	Detail	Changes
4	April. 15, 2019	Detail	Changes
3	Jan. 23, 2019	Detail	Changes
2	Jan. 17, 2019	Detail	Changes
1	Dec. 28, 2018	Detail

List of change history