PG2 injections for moderate-to-severe fatigue in women with advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, placebo-controlled interventional trial gives weekly injections of PG2 or saline placebo to women with recurrent unresectable or metastatic breast cancer who report moderate-to-severe fatigue while receiving infusional chemotherapy. Participants receive the assigned injection for an 8-week priming period during chemotherapy, and fatigue is tracked using the Brief Fatigue Inventory (BFI). The primary endpoint is the prorated area under the curve (AUC) for BFI scores over the treatment period, and secondary endpoints include fatigue response rate (≥10% reduction in total BFI), patient-reported improvement, hematologic measures, quality of life, and safety. Eligibility requires controlled pain, adequate laboratory values, ECOG performance status ≤2, and ability to complete questionnaires.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Women aged ≥ 20 years
2. ECOG performance score ≤ 2
3. Locally advanced, recurrent or metastatic, histologically documented breast cancer who is currently undergoing infusional chemotherapy regimen.
4. Presence of moderate to severe cancer related fatigue prior to randomization as defined by at least two records of usual fatigue score ≥ 4 on the numeric scale (0 -10), which must be ≥ 14 days apart.
5. Laboratory values obtained prior to randomization:

   * Hgb ≥ 10 g/dL (patients must not be transfused ≤ 14 days to meet this criterion)
   * Creatinine ≤ 1.2 x ULN
   * AST (SGOT) or ALT (SGPT) ≤1.5 x ULN (or ≤5.0 x ULN for patients with liver metastases)
6. Pain under controlled of score ≤ 4 on the numeric scale (0 -10)
7. Life expectancy ≥ 3 months
8. Ability to complete patient questionnaires alone or with assistance.
9. Negative pregnancy test done ≤ 14 days prior to randomization, for women of childbearing potential only, and willing to take efficient contraceptives procedures to avoid pregnancy throughout the study period.
10. Willing to provide written informed consent and agree to follow the study requirements.

Exclusion Criteria:

1. Known brain metastasis or primary CNS malignancy
2. Has known psychiatric or substance abuse disorders.
3. Malnutrition, active infection, uncontrolled thyroid disorder, uncontrollable hypertension or diabetes mellitus, significant pulmonary disease and cardiovascular disease.
4. Currently using any other pharmacologic agents.
5. Subject who is unwilling to receive transfusions when, at the investigator's discretion, it is required to control her anemia.
6. Other medical conditions that necessitate chronic systemic use of steroids (e.g. use of prednisolone \> 10 mg daily or equivalent steroids fore more than 2 weeks).
7. ≤ 4 weeks from major surgery to randomization, including any procedure that requires general anesthetics.
8. Pain requiring opioid pain medication, however, over the counter analgesics such as acetaminophen or ibuprofen are allowed.
9. Use of monoamine oxidase inhibitors (MAOI) (such as Moclobemide).
10. Planning to start or complete any type of cancer therapy during the 8 weeks course of the study, once randomized on the study.
11. Use of any over the counter herbal/dietary supplement marketed for fatigue or energy.
12. Known history of hypersensitivity to Astragalus products.
13. Currently participating another interventional study or planning to join one in the upcoming 8 weeks after randomization.
14. Currently breast feeding.
15. With any other serious disease considered by the investigator not in the condition to enter into the trial.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Wei-Wu Chen, MD — National Taiwan University Hospital
• Study coordinator: Tim Teng-Hsu Wang, PhD
• Email: tim.wang@phytohealth.com.tw
• Phone: +886 2 2545-3697

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.