Clinical trial NCT03314805: PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy
Official title: PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer-related Fatigue
Neutropenia, Malignant
Keywords: astragalus polysaccharides
breast cancer
adjuvant chemotherapy
Lead sponsor: PhytoHealth Corporation
Sponsor class: INDUSTRY
First posted: 2017-10-19
Enrollment: 67
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment among stage II/III breast patients under adjuvant EC regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Women who are able to provide informed consent
* Age 20 years and older
* Diagnosis of stage II to III breast cancer
* Patients who had undergone surgery for breast cancer treatment.
* Planning to receive anthracycline -based adjuvant chemotherapy
* Have adequate bone marrow, liver, and renal function
* ECOG ≦1
* Willing and able to complete quality of life questionnaires.

Exclusion Criteria:

* Pregnancy or lactating women.
* Baseline BFI score \>3.
* History of chronic fatigue syndrome, uncontrolled active infection, active cardiac disease, poor controlled hypertension or diabetes mellitus, any serious medical condition, psychiatric illness, and regular steroid therapy as determined by investigators.
* History of previous breast cancer or other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer.
* Known severe allergy to Astragalus membranaceus or its mayor extracts (polysaccharides).

Primary outcomes:
measure: Change in chemotherapy-related fatigue by brief fatigue Inventory
timeFrame: through 4 chemotherapy cycles (each cycle is 21 days)
measure: Incidence of Grade 3/4 neutropenia
timeFrame: through 4 chemotherapy cycles (each cycle is 21 days)
Secondary outcomes:
measure: Incidence of other Grade 3/4 Hematologic Toxicities
timeFrame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
measure: Chemotherapy Dose Reductions
timeFrame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
measure: Days of chemotherapy delay
timeFrame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
measure: Cumulative Doses of G-CSF consumption
timeFrame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
measure: Health-related Quality of Life by EORTC QLQ-C30 & Br23
timeFrame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
measure: ECOG
timeFrame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: E-Da Cancer Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital, Kaohsiung Branch
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Lovers Lake branch
city: Taipei City
country: Taiwan
facility: Chang Gung Memorial Hospital, Taipei Branch
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou Branch
Study officials:
affiliation: E-Da Cancer Hospital
name: Kun-Ming Rau, MD
role: PRINCIPAL_INVESTIGATOR
References: