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Effects of PG2 on Fatigue-Related Symptom Clusters

Sponsor
Taipei Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT02740959
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
14.2
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Astragalus Polysaccharides 500 mg
  • Drug: Astragalus Polysaccharides 250 mg
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of PG2 on Fatigue-Related Symptom Clusters
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
May 8, 2017
Actual Study Completion Date :
May 8, 2017

Arms and Interventions

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)

Drug: Astragalus 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)
Other Names:
  • PG2 Injection 500 mg PG2 (500 mg in 500 ml saline)

    		•
    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
    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:
  • PG2 Injection 250 mg PG2 (250 mg in 500 ml saline)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pittsburgh Sleep Quality Scale [about 5-10 minutes]

    2. Hospital Anxiety and Depression Scale [about 5-10 minutes]

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Medical University -Shung Ho Hospital Taipei Taiwan 235

    Sponsors and Collaborators

    • Taipei Medical University

    Investigators

    • Principal Investigator: Lin C Chin, PhD., RN, Taipei Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chia-Chin Lin, Dean, Taipei Medical University
    ClinicalTrials.gov Identifier:
    NCT02740959
    Other Study ID Numbers:
    • N201509006
    First Posted:
    Apr 15, 2016
    Last Update Posted:
    Sep 12, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Fatigue
    Syndrome

    Study Results

    No Results Posted as of Sep 12, 2018