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Recruiting Phase 2

PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients

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About this study

The objective of this study is to assess the efficacy of weekly PG2 regimen as a complementary treatment for patients with recurrent unresectable (local or regional) or metastatic breast cancer who experienced moderate to severe fatigue while receiving chemotherapies.

Condition
Cancer-related Fatigue
Tested
PG2 Lyo. Injection 500mg, Placebo 0.9% normal saline
Sponsor
PhytoHealth Corporation

Who can join

Age
20 years and older
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 16

  • Minimum age: 20 years
  • Eligible sex: Female
  • Study condition: Cancer-related Fatigue
  • Women aged ≥ 20 years
  • ECOG performance score ≤ 2
  • Locally advanced, recurrent or metastatic, histologically documented breast cancer who is currently undergoing infusional chemotherapy regimen.
  • 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.
  • 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)
  • Pain under controlled of score ≤ 4 on the numeric scale (0 -10)
  • Life expectancy ≥ 3 months
  • Ability to complete patient questionnaires alone or with assistance.
  • 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.
  • Willing to provide written informed consent and agree to follow the study requirements.

Exclusion 15

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

Where

1 site, 1 recruiting

National Taiwan University Hospital

Taipei, Taiwan

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.