- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02740959
Effects of PG2 on Fatigue-Related Symptom Clusters
September 11, 2018 updated by: Chia-Chin Lin, Taipei Medical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 235
- Taipei Medical University -Shung Ho Hospital
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
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)
Other Names:
|
Experimental: 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)
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Scale
Time Frame: about 5-10 minutes
|
about 5-10 minutes
|
|
Hospital Anxiety and Depression Scale
Time Frame: about 5-10 minutes
|
about 5-10 minutes
|
|
Actigraphy measuring circadian rhythm
Time Frame: 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
|
3-month course of treatment, a total of three measurements, each measurement 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lin C Chin, PhD., RN, Taipei Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
May 8, 2017
Study Completion (Actual)
May 8, 2017
Study Registration Dates
First Submitted
February 16, 2016
First Submitted That Met QC Criteria
April 12, 2016
First Posted (Estimate)
April 15, 2016
Study Record Updates
Last Update Posted (Actual)
September 12, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201509006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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