CompletedPhase 2

PG2 Breast Cancer Evaluation in Adjuvant Medicine Study

Taiwan67 participantsStarted 2018-03-01

Plain-language 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. 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.

Who can participate

Age range

20 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in chemotherapy-related fatigue by brief fatigue Inventory

Timeframe: through 4 chemotherapy cycles (each cycle is 21 days)

Incidence of Grade 3/4 neutropenia

Timeframe: through 4 chemotherapy cycles (each cycle is 21 days)

Trial details

NCT IDNCT03314805

SponsorPhytoHealth Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-26

View on ClinicalTrials.gov More Cancer-related Fatigue trials