Effects of PG2 on Fatigue-Related Symptom Clusters

NCT ID: NCT02740959

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-05-08

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.

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

Conditions

Cancer-related Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Astragalus Polysaccharides 500 mg

Intervention Type: 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)

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)

Group Type: EXPERIMENTAL

Astragalus Polysaccharides 250 mg

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

PG2 Injection 500 mg PG2 (500 mg in 500 ml saline); PG2 Injection 250 mg PG2 (250 mg in 500 ml saline)

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chia-Chin Lin

Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin C Chin, PhD., RN

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University -Shung Ho Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N201509006

Identifier Type: -

Identifier Source: org_study_id