PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients
ConditionCancer-related Fatigue
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age20+
SponsorPhytoHealth Corporation
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PG2 Lyo. Injection 500mg
- Placebo 0.9% normal saline
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov