Clinical trial NCT02740959: Effects of PG2 on Fatigue-Related Symptom Clusters
Official title: Effects of PG2 on Fatigue-Related Symptom Clusters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Fatigue
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Pittsburgh Sleep Quality Scale
timeFrame: about 5-10 minutes
measure: Hospital Anxiety and Depression Scale
timeFrame: about 5-10 minutes
measure: Actigraphy measuring circadian rhythm
timeFrame: 3-month course of treatment, a total of three measurements, each measurement 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University -Shung Ho Hospital
Study officials:
affiliation: Taipei Medical University
name: Lin C Chin, PhD., RN
role: PRINCIPAL_INVESTIGATOR
References: