Effects of PG2 on Fatigue-Related Symptom Clusters

• Status: Completed
• Trial end date: 2017-05-08
• Target enrollment: 0
• Participant gender: All

Summary

This study is for an "add-on" study to the "main" study (Protocol No.: PH-CP012). The information of patients from main study will be collected by questionnaire survey and actigraphy measurement to evaluate the relationship between fatigue, depression and sleep disorder and the efficacy of PG2 after treatment.The association between symptom cluster and circadian rhythm will be also further explored.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Medical University

Criteria

Inclusion Criteria:

• Patients who signed the informed consent form

• The age of eligible patients should be 20 years old.

• Eligible patients must have locally advanced or metastatic cancer or inoperable advanced cancer.

• Patients are under standard palliative care (SPC) at hospice setting and have no further curative options available.

• Patients with BFI fatigue score 4 during screening.

• Patients have a life expectancy of at least 3 months as determined by the investigator.

• Patient must be willing and able to complete quality of life questionnaires.

Exclusion Criteria:

• Female patients are pregnant or breast-feeding.

• Patients with uncontrolled systemic disease such as active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus.

• Patients take central nervous system stimulators such as Methylphenidate within 30 days before screening.

• Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.

• Patients with Karnofsky Performance Scores less than 30 % at time of screening

• Patients who are diagnosed as dying status