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

Korábbi kezelés

• Currently using any other pharmacologic agents.
• ≤ 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).

Más betegség

• 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.
• 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).
• Planning to start or complete any type of cancer therapy during the 8 weeks course of the study, once randomized on the study.
• Known history of hypersensitivity to Astragalus products.
• With any other serious disease considered by the investigator not in the condition to enter into the trial.

Egyéb

• Subject who is unwilling to receive transfusions when, at the investigator's discretion, it is required to control her anemia.
• Use of any over the counter herbal/dietary supplement marketed for fatigue or energy.
• Currently participating another interventional study or planning to join one in the upcoming 8 weeks after randomization.
• Currently breast feeding.

• 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.