NCT05440227 PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients
| NCT ID | NCT05440227 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | PhytoHealth Corporation |
| Condition | Cancer-related Fatigue |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-05-17 |
| Primary Completion | 2025-12 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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.
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 pr
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.