Cancer-related FatiguePhase 2PG2 BEAMNCT03314805
PG2 Breast Cancer Evaluation in Adjuvant Medicine Study
A Phase 2 study testing Astragalus polysaccharides 500 mg and EC Chemotherapy in people with Cancer-related Fatigue and Neutropenia, Malignant, run by PhytoHealth Corporation at 5 sites in Taiwan.
Trial summary
Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cancer-related Fatigue, Neutropenia, Malignant
- What is being tested?
- Astragalus polysaccharides 500 mg and EC Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 5 sitesTaiwan
- Study dates
- 1 Mar 2018to 27 Aug 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are able to provide informed consent
- Age 20 years and older
- Diagnosis of stage II to III breast cancer
- Patients who had undergone surgery for breast cancer treatment.
- Planning to receive anthracycline -based adjuvant chemotherapy
- Have adequate bone marrow, liver, and renal function
- ECOG ≦1
- Willing and able to complete quality of life questionnaires.
Who cannot join
- Pregnancy or lactating women.
- Baseline BFI score >3.
- History of chronic fatigue syndrome, uncontrolled active infection, active cardiac disease, poor controlled hypertension or diabetes mellitus, any serious medical condition, psychiatric illness, and regular steroid therapy as determined by investigators.
- History of previous breast cancer or other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer.
- Known severe allergy to Astragalus membranaceus or its mayor extracts (polysaccharides).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
E-Da Cancer Hospital
Kaohsiung City, 824
Chang Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City, 833
Chang Gung Memorial Hospital, Lovers Lake branch
Keelung, 204
Chang Gung Memorial Hospital, Taipei Branch
Taipei, 105
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan City, 333
About this study
Official title: PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy
Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment among stage II/III breast patients under adjuvant EC regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.
- Conditions
- Cancer-related Fatigue, Neutropenia, Malignant
- Being tested
- Astragalus polysaccharides 500 mg, Placebo, EC Chemotherapy
- Keywords
- astragalus polysaccharides, breast cancer, adjuvant chemotherapy
- Medical subject headings
- Acquired agranulocytosis, Breast 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 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle
PlaceboDrug
500 ml saline, 3 days via i.v. infusion per chemotherapy cycle
EC ChemotherapyProcedure or surgery
Epirubicin plus Cyclophosphamide every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo Receives: Drug: Placebo; Procedure: EC Chemotherapy |
| Treatment | Experimental | Astragalus polysaccharides 500 mg Receives: Drug: Astragalus polysaccharides 500 mg; Procedure: EC Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in chemotherapy-related fatigue by brief fatigue Inventory
Measured: through 4 chemotherapy cycles (each cycle is 21 days)
Incidence of Grade 3/4 neutropenia
Measured: through 4 chemotherapy cycles (each cycle is 21 days)
Secondary outcomes (6)
Incidence of other Grade 3/4 Hematologic Toxicities
Measured: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Chemotherapy Dose Reductions
Measured: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Days of chemotherapy delay
Measured: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Cumulative Doses of G-CSF consumption
Measured: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Health-related Quality of Life by EORTC QLQ-C30 & Br23
Measured: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
ECOG
Measured: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Mar 2018
- Primary completion26 May 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kun-Ming Rau, MD, Principal investigator, E-Da Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314805
- Sponsor's protocol ID
- PH-CP026
- Acronym
- PG2 BEAM
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2017
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen WC, Chen SC, Wang CH, Hung CM, Peng MT, Liu CT, Chang YS, Kuo WL, Chou HH, Yeh KY, Wu TH, Wu CF, Chang PH, Huang YM, Yu CC, Lee CH, Rau KM. Astragalus polysaccharides improve adjuvant chemotherapy-induced fatigue for patients with early breast cancer. Sci Rep. 2024 Oct 28;14(1):25690. doi: 10.1038/s41598-024-76627-z.
PubMed 39465324
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03314805
- Acronym / sponsor ID
- PG2 BEAM / PH-CP026
- Conditions
- Cancer-related Fatigue, Neutropenia, Malignant
- Keywords
- astragalus polysaccharides, breast cancer, adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 19 Oct 2017 (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.
Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment among stage II/III breast patients under adjuvant EC regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.
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 |
|---|---|---|
| Control | Placebo comparator | Drug: Placebo, Procedure: EC ChemotherapyPlacebo |
| Treatment | Experimental | Drug: Astragalus polysaccharides 500 mg, Procedure: EC ChemotherapyAstragalus polysaccharides 500 mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women who are able to provide informed consent
- Age 20 years and older
- Diagnosis of stage II to III breast cancer
- Patients who had undergone surgery for breast cancer treatment.
- Planning to receive anthracycline -based adjuvant chemotherapy
Key exclusion criteria (5 listed)
- Pregnancy or lactating women.
- Baseline BFI score >3.
- History of chronic fatigue syndrome, uncontrolled active infection, active cardiac disease, poor controlled hypertension or diabetes mellitus, any serious medical condition, psychiatric illness, and regular steroid therapy as determined by investigators.
- History of previous breast cancer or other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer.
- Known severe allergy to Astragalus membranaceus or its mayor extracts (polysaccharides).
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 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle | Drug | Treatment |
| Placebo500 ml saline, 3 days via i.v. infusion per chemotherapy cycle | Drug | Control |
| EC ChemotherapyEpirubicin plus Cyclophosphamide every 21 days | Procedure or surgery | Control, Treatment |
Primary outcome
Change in chemotherapy-related fatigue by brief fatigue Inventory
Time frame: through 4 chemotherapy cycles (each cycle is 21 days)
Incidence of Grade 3/4 neutropenia
Time frame: through 4 chemotherapy cycles (each cycle is 21 days)
6 secondary outcomes
Incidence of other Grade 3/4 Hematologic Toxicities
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Chemotherapy Dose Reductions
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Days of chemotherapy delay
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Cumulative Doses of G-CSF consumption
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Health-related Quality of Life by EORTC QLQ-C30 & Br23
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
ECOG
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
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 17 Jun 2026.
- Derived from this study: PubMed 39465324Shen WC, Chen SC, Wang CH, Hung CM, Peng MT, Liu CT, Chang YS, Kuo WL, Chou HH, Yeh KY, Wu TH, Wu CF, Chang PH, Huang YM, Yu CC, Lee CH, Rau KM. Astragalus polysaccharides improve adjuvant chemotherapy-induced fatigue for patients with early breast cancer. Sci Rep. 2024 Oct 28;14(1):25690. doi: 10.1038/s41598-024-76627-z.
- Individual participant dataSharing planned: No
Related trials for Cancer-related Fatigue
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)
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
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
Active, not recruiting
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Chronic Insomnia, Cancer-related Problem/Condition
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.
Kun-Ming Rau, MD principal investigator
E-Da Cancer Hospital
5 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 and EC Chemotherapy in people with Cancer-related Fatigue and Neutropenia, Malignant, run by PhytoHealth Corporation at 5 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 8 inclusion and 5 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. Some participants in this study may receive a placebo. 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?
Change in chemotherapy-related fatigue by brief fatigue Inventory (time frame: through 4 chemotherapy cycles (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314805, which also lists 1 linked publication.
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 17 Jun 2026.