Cancer-related FatiguePhase 2NCT03611712
PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer
A Phase 2 study testing Astragalus Polysaccharides 500 mg in people with Cancer-related Fatigue and Survival, run by PhytoHealth Corporation at 4 sites in Taiwan.
Trial summary
The primary objective of this study is to evaluate the efficacy of PG2 concurrent with concurrent chemoradiation therapy (CCRT) for relieving fatigue among locally advanced esophageal cancer patients who are under preoperative chemoradiation therapy at curative setting. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cancer-related Fatigue, Survival, Tumor, Esophageal
- What is being tested?
- Astragalus Polysaccharides 500 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesTaiwan
- Study dates
- 19 Feb 2019to 5 Mar 2025
- Phase
- Phase 2
- 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 to 75 years
- 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 20-75 years old;
- Performance status of ECOG 0-1 at time of screening;
- Have Esophageal and esophagogastric junction cancer (non-cervical esophagus);
- Have stage IIB-IIIB locally advanced carcinoma of esophagus;
- Pathologically confirmed primary squamous cell carcinoma of the esophagus;
- Patient must be willing and able to complete fatigue and quality of life questionnaires.
Who cannot join
- BFI > 7 at time of screening;
- Concomitant malignancy or prior invasive malignancy unless disease free for a minimum of 2 years;
- Medical contraindications to esophagectomy;
- Female patients are pregnant or breast-feeding;
- Have inadequate bone marrow, liver, and renal function
- Uncontrolled systemic disease
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- Regular steroid use as determined by investigators;
- 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.
- BMI < 16
- Nutrition status SGA rating C.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Mackay Memorial Hospital
Taipei, 104
Tri-Service General Hospital
Taipei, 114
Far Eastern Memorial Hospital
Taipei, 220
Taipei Medical University -Shung Ho Hospital
Taipei, 235
About this study
The primary objective of this study is to evaluate the efficacy of PG2 concurrent with concurrent chemoradiation therapy (CCRT) for relieving fatigue among locally advanced esophageal cancer patients who are under preoperative chemoradiation therapy at curative setting. This study will be designed to compare the fatigue status between two study arms patients under CCRT.
The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Also, the investigators try to determine the effect of PG2 on tumor response post CCRT, disease free survival (DFS) and overall survival (OS) of patients by comparing the above outcome between the two study arms.
The mechanism of immunomodulatory of PG2 and tumor response, DFS and OS for patients with esophageal cancer treated with preoperative CCRT concurrent with or without PG2 will be investigated in add-on study.
Read the detailed description
It's randomized, open-label study. Locally advanced esophageal cancer patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. The eligible patients will be randomized into one of two study arms: 1) the CCRT- PG2 arm; and 2) the CCRT alone arm. All eligible patients will receive the standard preoperative CCRT during study period and standard surgery 6 weeks after completion of radiation therapy.
The primary objective of this study is to evaluate the efficacy of PG2 concurrent with CCRT for relieving fatigue. Patient's fatigue status will be measured by the BFI-T.
The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Patients' quality of life will be assessed by the Functional Assessment of Cancer Therapy- General (FACT-G7 v.4). Patients' appetite will be assessed by VAS appetite score. The effect of PG2 on tumor response post CCRT, DFS and OS of patients will also be evaluated.
Peripheral blood samples and tumor biopsy samples will be collected from all subjects at screening period, during CCRT and post CCRT period to perform Immune biomarker assessment in the add-on study.
- Conditions
- Cancer-related Fatigue, Survival, Tumor, Esophageal
- Being tested
- Astragalus Polysaccharides 500 mg
- Keywords
- Cancer-related Fatigue, Tumor response, Survival, Chemoradiation, esophageal cancer
- Medical subject headings
- Neoplasms, Esophageal Neoplasms
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 Lyo. Injection 500 mg
PG2 Lyo. Injection 500 mg will be given on 1 week before CCRT (Week 1, PG2 Lyo. Injection 500 mg, b.i.w), during CCRT (Week 2-6, PG2 Lyo. Injection 500 mg, t.i.w for 5 weeks), and after CCRT (Week 7-8, PG2 Lyo. Injection 500 mg, t.i.w for 2 weeks)
| Study group | Role | What they receive |
|---|---|---|
| CCRT-PG2 arm | Experimental | Astragalus Polysaccharides 500 mg Receives: Drug: Astragalus Polysaccharides 500 mg |
| CCRT alone arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue by the Brief Fatigue Inventory-Taiwanese Form
The Brief Fatigue Inventory (BFI) has been shown to have good reliability of fatigue measurement. This instrument consists of a one-page fatigue assessment tool that contains nine items, each measuring the severity of fatigue on a 0-through-10 scale. The first three items assess current level of fatigue, and worst and usual fatigue in the preceding 24 hours. Six items assess the extent to which fatigue has interfered with different aspects of life, such as work or social relations, during the preceding 24 hours. The BFI score is calculated from the mean of completed items.
Measured: Through 12 weeks
Secondary outcomes (6)
Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G7 v.4)
FACT-G7, a rapid version of the Functional Assessment of Cancer Therapy-General (FACT-G) which is one of most validated assessment tools to evaluate health related qulaity of life (HRQoL) among cancer patients. It is a 27-item instrument containing four subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB) on 0-4 scale with a recall period of the past 7 days. The scores of these items must be reversed, and then summed to a total, which is the subscale score. The higher score is presented as the better quality of life.
Measured: Through 12 weeks
Visual Analog Score for appetite
Visual Analog Score for appetite is a single-item scale will be used to measure by A 10-cm vertical line anchored with the number 0 to indicate "no appetite" and number 10 to indicate "worst possible appetite."
Measured: Through 12 weeks
Tumor response be evaluated by RECIST 1.1, irRECIST and Pathological response.
Measured: Week 11 and Week 12
Disease free survival
Disease free survival (DFS) is defined as the time from initiation to relapse or death, whichever occurred first.
Measured: 2 years after the take-off day of the last patient
Overall survival in locally advanced esophageal cancer patients with PG2 treatment under preoperative chemoradiation therapy
Overall survival (OS) is defined as the time from initiation to death of any cause.
Measured: 2 years after the take-off day of the last patient
The change of of biomarkers (inhibitory immune factors, dendritic cells makers, tumor-associated macrophages, immune-regulatory markers and oncogenic-mediated immune markers) will be combined to report the immune profile.
Measured: Through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start19 Feb 2019
- Primary completion3 Feb 2023
- Study completion5 Mar 2025
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen-Chien WC Huang, MD, PhD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611712
- Sponsor's protocol ID
- PH-CP028
- Status last verified
- Jun 2025
- First submitted
- 10 Jul 2018
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03611712
- Acronym / sponsor ID
- PH-CP028
- Conditions
- Cancer-related Fatigue, Survival, Tumor, Esophageal
- Keywords
- Cancer-related Fatigue, Tumor response, Survival, Chemoradiation, esophageal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 2 Aug 2018 (actual)
- 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.
The primary objective of this study is to evaluate the efficacy of PG2 concurrent with concurrent chemoradiation therapy (CCRT) for relieving fatigue among locally advanced esophageal cancer patients who are under preoperative chemoradiation therapy at curative setting. This study will be designed to compare the fatigue status between two study arms patients under CCRT.
The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Also, the investigators try to determine the effect of PG2 on tumor response post CCRT, disease free survival (DFS) and overall survival (OS) of patients by comparing the above outcome between the two study arms.
The mechanism of immunomodulatory of PG2 and tumor response, DFS and OS for patients with esophageal cancer treated with preoperative CCRT concurrent with or without PG2 will be investigated in add-on study.
Detailed description
It's randomized, open-label study. Locally advanced esophageal cancer patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. The eligible patients will be randomized into one of two study arms: 1) the CCRT- PG2 arm; and 2) the CCRT alone arm. All eligible patients will receive the standard preoperative CCRT during study period and standard surgery 6 weeks after completion of radiation therapy.
The primary objective of this study is to evaluate the efficacy of PG2 concurrent with CCRT for relieving fatigue. Patient's fatigue status will be measured by the BFI-T.
The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Patients' quality of life will be assessed by the Functional Assessment of Cancer Therapy- General (FACT-G7 v.4). Patients' appetite will be assessed by VAS appetite score. The effect of PG2 on tumor response post CCRT, DFS and OS of patients will also be evaluated.
Peripheral blood samples and tumor biopsy samples will be collected from all subjects at screening period, during CCRT and post CCRT period to perform Immune biomarker assessment in the add-on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCRT-PG2 arm | Experimental | Drug: Astragalus Polysaccharides 500 mgAstragalus Polysaccharides 500 mg |
| CCRT alone arm | No intervention | – |
Who may qualify
- Ages
- 20 to 75 years
- 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 20-75 years old;
- Performance status of ECOG 0-1 at time of screening;
- Have Esophageal and esophagogastric junction cancer (non-cervical esophagus);
- Have stage IIB-IIIB locally advanced carcinoma of esophagus;
Key exclusion criteria (11 listed)
- BFI > 7 at time of screening;
- Concomitant malignancy or prior invasive malignancy unless disease free for a minimum of 2 years;
- Medical contraindications to esophagectomy;
- Female patients are pregnant or breast-feeding;
- Have inadequate bone marrow, liver, and renal function
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 Lyo. Injection 500 mgPG2 Lyo. Injection 500 mg will be given on 1 week before CCRT (Week 1, PG2 Lyo. Injection 500 mg, b.i.w), during CCRT (Week 2-6, PG2 Lyo. Injection 500 mg, t.i.w for 5 weeks), and after CCRT (Week 7-8, PG2 Lyo. Injection 500 mg, t.i.w for 2 weeks) | Drug | CCRT-PG2 arm |
Primary outcome
Fatigue by the Brief Fatigue Inventory-Taiwanese Form
Time frame: Through 12 weeks
The Brief Fatigue Inventory (BFI) has been shown to have good reliability of fatigue measurement. This instrument consists of a one-page fatigue assessment tool that contains nine items, each measuring the severity of fatigue on a 0-through-10 scale. The first three items assess current level of fatigue, and worst and usual fatigue in the preceding 24 hours. Six items assess the extent to which fatigue has interfered with different aspects of life, such as work or social relations, during the preceding 24 hours. The BFI score is calculated from the mean of completed items.
6 secondary outcomes
Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G7 v.4)
Time frame: Through 12 weeks
Visual Analog Score for appetite
Time frame: Through 12 weeks
Tumor response be evaluated by RECIST 1.1, irRECIST and Pathological response.
Time frame: Week 11 and Week 12
Disease free survival
Time frame: 2 years after the take-off day of the last patient
Overall survival in locally advanced esophageal cancer patients with PG2 treatment under preoperative chemoradiation therapy
Time frame: 2 years after the take-off day of the last patient
The change of of biomarkers (inhibitory immune factors, dendritic cells makers, tumor-associated macrophages, immune-regulatory markers and oncogenic-mediated immune markers) will be combined to report the immune profile.
Time frame: Through 12 weeks
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 4 Jun 2025.
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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.
Wen-Chien WC Huang, MD, PhD principal investigator
Mackay Memorial Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Astragalus Polysaccharides 500 mg in people with Cancer-related Fatigue and Survival, run by PhytoHealth Corporation at 4 sites 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 11 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fatigue by the Brief Fatigue Inventory-Taiwanese Form (time frame: Through 12 weeks). 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 4 Jun 2025.