cancer
Conditions
Interventions
Placebo Group:Brown rice powder
Test Group:1040 mg of TM02
Sponsors
Merican Mahmood Research Grant (MMRG)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1 Diagnosed with Stage I- IIIA invasive breast carcinoma regardless of steroid receptor (estrogen/progesterone) status HER2 status and menopausal status. 2 Have completed adjuvant chemotherapy within 14 to 21 days prior to start of first dose TM02®. 3 May be on concomitant radiotherapy or hormonal therapy. 4 Eastern Cooperative Oncology Group (ECOG) performance status of grade 0 to 2. 5 Adequate organ function: Absolute neutrophil count (ANC) > 1000mm3; Platelet count > 100000/mm3; serum creatinine < 1.5 mg/dL serum bilirubin < the institutional upper limit of normal; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the upper limit of normal. 6 No known allergy to mushrooms. 7 Provides consent to participate in trial and adhere to the study protocol
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Receiving concomitant investigational drugs or supplements 2 Uncontrolled concurrent illness such as active infection hypertension heart disease (ischemic heart disease heart failure cardiac arrhythmia) uncontrolled diabetes HIV infection or other psychiatric illness/ social situations that might limit adherence to study protocol 3 Pregnant / breast feeding women 4 Unable or unwilling to stop taking vitamins herbal remedies or non-prescription medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health Related Quality of Life (HRQoL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale; | — |
Countries
Malaysia
Contacts
Public ContactJie-Yi Eng
Clinical Oncologist UMMC
Outcome results
None listed