search
Back to results

Effects of PG2 on Fatigue-Related Symptom Clusters

Primary Purpose

Cancer-related Fatigue

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Astragalus Polysaccharides 500 mg
Astragalus Polysaccharides 250 mg
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Fatigue

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Medical University -Shung Ho Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Astragalus Polysaccharides 500 mg

Astragalus Polysaccharides 250 mg

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Quality Scale
Hospital Anxiety and Depression Scale
Actigraphy measuring circadian rhythm
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

Secondary Outcome Measures

Full Information

First Posted
February 16, 2016
Last Updated
September 11, 2018
Sponsor
Taipei Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT02740959
Brief Title
Effects of PG2 on Fatigue-Related Symptom Clusters
Official Title
Effects of PG2 on Fatigue-Related Symptom Clusters
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 8, 2017 (Actual)
Study Completion Date
May 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Astragalus Polysaccharides 500 mg
Arm Type
Experimental
Arm Description
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)
Arm Title
Astragalus Polysaccharides 250 mg
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Astragalus Polysaccharides 500 mg
Other Intervention Name(s)
PG2 Injection 500 mg PG2 (500 mg in 500 ml saline)
Intervention Description
PG2 Injection 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)
Intervention Type
Drug
Intervention Name(s)
Astragalus Polysaccharides 250 mg
Other Intervention Name(s)
PG2 Injection 250 mg PG2 (250 mg in 500 ml saline)
Intervention Description
PG2 Injection 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)
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Scale
Time Frame
about 5-10 minutes
Title
Hospital Anxiety and Depression Scale
Time Frame
about 5-10 minutes
Title
Actigraphy measuring circadian rhythm
Description
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
Time Frame
3-month course of treatment, a total of three measurements, each measurement 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin C Chin, PhD., RN
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University -Shung Ho Hospital
City
Taipei
ZIP/Postal Code
235
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of PG2 on Fatigue-Related Symptom Clusters

We'll reach out to this number within 24 hrs