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New treatment option for Cancer-related Fatigue
Official title PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients
ClinicalTrials.gov ID: NCT05440227
What this study is testing
What is PG2 Lyo. Injection 500mg?
PG2 Lyo. Injection 500mg is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for cancer-related fatigue.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older, women only
You may be able to join if
- 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...
- Laboratory values obtained prior to randomization:
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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.
- 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 assigned by chance 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.