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

A Phase II, Double Blind, Randomized, Placebo-controlled Study of PG2 Injection for the Treatment of moderate-to Severe Fatigue in Patients With Locally Advanced, Recurrent, or Metastatic Breast Cancer Who Are Receiving Infusional Chemotherapy

This study will see if weekly PG2 injections can reduce moderate-to-severe fatigue in women with recurrent or metastatic breast cancer who are receiving chemotherapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 20 Years and up
• Sex: Female
• Sponsor: PhytoHealth Corporation (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Taipei)
• Trial ID: NCT05440227 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 20 or older with histologically confirmed locally advanced, recurrent, or metastatic breast cancer who are on infusional chemotherapy and have repeated moderate-to-severe fatigue (two scores ≥4 at least 14 days apart) with adequate labs and ECOG ≤2 are the intended participants.

Not a fit: Patients without moderate-to-severe fatigue, those not receiving infusional chemotherapy, those with ECOG >2, uncontrolled pain, or disqualifying lab abnormalities are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, PG2 could lessen chemotherapy-related fatigue and help improve daily functioning and quality of life for women with advanced breast cancer.

How similar studies have performed: Previous smaller studies of PG2 and similar botanical polysaccharide treatments have reported some positive signals for reducing cancer-related fatigue, but results are limited and not yet definitive.

Eligibility criteria

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 this trial is running

Taipei

• 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

Conditions: Cancer-related Fatigue, breast cancer, fatigue, CRF