NCT02740959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2017

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

February 16, 2016

Last Update Submit

September 11, 2018

Conditions

Cancer-related Fatigue

Outcome Measures

Primary Outcomes (3)

  • Pittsburgh Sleep Quality Scale

    about 5-10 minutes

  • Hospital Anxiety and Depression Scale

    about 5-10 minutes

  • 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

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

Study Arms (2)

Astragalus Polysaccharides 500 mg

EXPERIMENTAL

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

Astragalus Polysaccharides 250 mg

EXPERIMENTAL

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

Astragalus Polysaccharides 500 mgDRUG

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)
Astragalus Polysaccharides 500 mg
Astragalus Polysaccharides 250 mgDRUG

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)
Astragalus Polysaccharides 250 mg

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University -Shung Ho Hospital

Taipei, 235, Taiwan

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Lin C Chin, PhD., RN

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean

Study Record Dates

First Submitted

February 16, 2016

First Posted

April 15, 2016

Study Start

March 1, 2016

Primary Completion

May 8, 2017

Study Completion

May 8, 2017

Last Updated

September 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)