NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180068

Registered date:28/12/2018

Dexamethasone for cancer-related fatigue in advanced cancer patients - multi-center phase II trial

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedA diagnosis of advanced cancer (defined as metastatic or recurrent)
Date of first enrollment26/10/2017
Target sample size32
Countries of recruitment
Study typeInterventional
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

Outcome(s)

Primary OutcomeThe change of FACIT-Fatigue subscale score at day 8
Secondary OutcomeThe 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaA 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
Exclude criteriaPatients 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

Related Information

Contact

Public contact
Name Ayumi Okizaki
Address Kashiwanoha 6-5-1, Kashiwa, Chiba, Japan Chiba Japan 277-8577
Telephone +81-4-7133-1111
E-mail aokizaki@east.ncc.go.jp
Affiliation National Cancer Center Hospital East
Scientific contact
Name Tomofumi Miura
Address Kashiwanoha 6-5-1, Kashiwa, Chiba, Japan Chiba Japan 277-8577
Telephone +81-4-7133-1111
E-mail tomiura@ncc.go.jp
Affiliation National Cancer Center Hospital East