Effects of PG2 on Fatigue-Related Symptom Clusters

Not Applicable

Completed

• Conditions: Cancer-related Fatigue
• Interventions: Drug: Astragalus Polysaccharides 250 mg; Drug: Astragalus Polysaccharides 500 mg

• Registration Number: NCT02740959
• Lead Sponsor: Taipei Medical University

Brief 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.

Detailed Description

The study is "PG2 Treatment for Improving Fatigue among Advanced Cancer Patients under Standard Palliative Care" (Protocol Number: PH-CP012) of the additional plan, through questionnaires and using actigraphy measuring circadian rhythm collect patient data master plans, assessed for "PG2" treatment of cancer patients before and after treatment fatigue, depression, sleep disorders and other related symptoms of resistance and the effectiveness of treatment, and to further explore the symptom clusters in cancer patients associated with the circadian rhythm

Study Timeline

• Study First Submitted: 2016-02-16
• Study Start: 2016-03
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Primary Completion: 2017-05-08
• Study Completion: 2017-05-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Astragalus Polysaccharides 250 mg	Astragalus Polysaccharides 250 mg	PG2 (250 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
Astragalus Polysaccharides 500 mg	Astragalus Polysaccharides 500 mg	PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	about 5-10 minutes
Pittsburgh Sleep Quality Scale	about 5-10 minutes
Actigraphy measuring circadian rhythm	3-month course of treatment, a total of three measurements, each measurement 7 days	three measurements means:3 days prior to the first dose of study medication began wearing courses of the last visits to the first week; last treatment of 3rd and 7th weeks of medication visits began wearing last time between the 4th and 8th week of visits

Trial Locations

Locations (1)

Taipei Medical University -Shung Ho Hospital; 🇨🇳 Taipei, Taiwan