Cancer-related FatigueNCT02740959
Effects of PG2 on Fatigue-Related Symptom Clusters
A study testing Astragalus Polysaccharides 500 mg and Astragalus Polysaccharides 250 mg in people with Cancer-related Fatigue, run by Taipei Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- Astragalus Polysaccharides 500 mg and Astragalus Polysaccharides 250 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2016to 8 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Astragalus Polysaccharides 500 mg, Astragalus Polysaccharides 250 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astragalus Polysaccharides 500 mgDrug
Also called PG2 Injection 500 mg PG2 (500 mg in 500 ml saline)
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 mgDrug
Also called PG2 Injection 250 mg PG2 (250 mg in 500 ml saline)
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Astragalus Polysaccharides 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Scale
Measured: about 5-10 minutes
Hospital Anxiety and Depression Scale
Measured: 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
Measured: 3-month course of treatment, a total of three measurements, each measurement 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion8 May 2017
- Study completion8 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Chin Lin, Taipei Medical University
- Investigators
- Lin C Chin, PhD., RN, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740959
- Sponsor's protocol ID
- N201509006
- Status last verified
- Sep 2018
- First submitted
- 16 Feb 2016
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PG2 on Fatigue-Related Symptom Clusters
- ClinicalTrials.gov ID
- NCT02740959
- Acronym / sponsor ID
- N201509006
- Conditions
- Cancer-related Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 8 May 2017 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astragalus Polysaccharides 500 mg | Experimental | Drug: Astragalus Polysaccharides 500 mgPG2 (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 | Experimental | Drug: Astragalus Polysaccharides 250 mgPG2 (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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astragalus Polysaccharides 500 mgAlso: PG2 Injection 500 mg PG2 (500 mg in 500 ml saline)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) | Drug | Astragalus Polysaccharides 500 mg |
| Astragalus Polysaccharides 250 mgAlso: PG2 Injection 250 mg PG2 (250 mg in 500 ml saline)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) | Drug | Astragalus Polysaccharides 250 mg |
Primary outcome
Pittsburgh Sleep Quality Scale
Time frame: about 5-10 minutes
Hospital Anxiety and Depression Scale
Time frame: about 5-10 minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Cancer-related Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
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Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Prostate Carcinoma
RecruitingPhase 3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Brain Tumor, Pediatric, Cancer-related Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin C Chin, PhD., RN principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astragalus Polysaccharides 500 mg and Astragalus Polysaccharides 250 mg in people with Cancer-related Fatigue, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Scale (time frame: about 5-10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.