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

JRCT ID: jRCTs031180068

Registered date:28/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: A diagnosis of advanced cancer (defined as metastatic or recurrent)
• Date of first enrollment: 26/10/2017
• Target sample size: 32
• Study type: Interventional

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 Outcome: The change of FACIT-Fatigue subscale score at day 8

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Miura Tomofumi
• Source(s) of Monetary Support: Japan Agency for Medical Research nd Development
• Secondary ID(s): UMIN000028877