Skip to main content
OpenTrials
Completed

NCT Number: NCT02740959

Effects of PG2 on Fatigue-Related Symptom Clusters

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer-related Fatigue

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University -Shung Ho Hospital

Taipei, 235, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Astragalus polysaccharides 500 mg

Drug

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)

Astragalus Polysaccharides 250 mg

Drug

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)

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

    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

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 15, 2016
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.