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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

PG2 Lyo. Injection 500mg
Drug
PG2 Lyo. Injection 500mg (reconstituted with 0.9% normal saline 500ml) will be administered weekly for 8 weeks.
Placebo 0.9% normal saline
Drug
0.9% normal saline 500ml will be administered weekly for 8 weeks.

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: PG2 treatment groupExperimental treatment 1 intervention

Group B: Placebo-controlled groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Prorated AUC for the global BFI score

The prorated AUC for the global BFI score (average scores of 9 items), usual fatigue (item2) and worst fatigue (item 3) will be compared between PG2 and the placebo arms at the end of the study.

Time frame

8 weeks

Secondary outcomes

Fatigue improvement response rate (FIRR)

FIRR is defined as those with at least 10% reduction from baseline in the total BFI scores after 8-week treatment. 20% and 30% reduction will also be evaluated.

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PhytoHealth Corporation

Lead sponsor

Source ClinicalTrials.gov

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