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CompletedNCT02740959Updated Sep 12, 2018

Effects of PG2 on Fatigue-Related Symptom Clusters

An interventional study of Astragalus Polysaccharides 500 mg and Astragalus Polysaccharides 250 mg in Cancer-related Fatigue, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-09-12.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Cancer-related Fatigue
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 6 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
6 participants (actual)

Study arms

  • 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)

    Drug: Astragalus Polysaccharides 500 mg

  • 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)

    Drug: Astragalus Polysaccharides 250 mg

Interventions

  • DrugAstragalus Polysaccharides 500 mg

    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)

    Also known as: PG2 Injection 500 mg PG2 (500 mg in 500 ml saline)

  • DrugAstragalus Polysaccharides 250 mg

    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)

    Also known as: PG2 Injection 250 mg PG2 (250 mg in 500 ml saline)

06

What researchers measure

Primary outcomes

  1. Pittsburgh Sleep Quality Scale

    Time frame: about 5-10 minutes

  2. Hospital Anxiety and Depression Scale

    Time frame: about 5-10 minutes

  3. 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

    Time frame: 3-month course of treatment, a total of three measurements, each measurement 7 days

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Study locations

1 site
  • Taipei Medical University -Shung Ho Hospital
    Taipei, 235, Taiwan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02740959
Lead sponsor
Taipei Medical University
Responsible party
Chia-Chin Lin (Dean, Taipei Medical University) — Principal investigator
First posted
Apr 15, 2016
Start date
Mar 2016
Primary completion
May 8, 2017
Completion
May 8, 2017
Last update
Sep 12, 2018

Study contacts

Lin C Chin, PhD., RN
principal investigator · Taipei Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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