Effects of PG2 on Fatigue-Related Symptom Clusters

Taipei Medical University

Status

Completed

Conditions

Cancer-related Fatigue

Treatments

Drug: Astragalus Polysaccharides 250 mg

Drug: Astragalus Polysaccharides 500 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02740959

N201509006

Details and patient eligibility

About

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.

Full 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

Enrollment

6 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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