Assessment of the Safety of Dietary Supplement Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy
Randomization and Treatment: The subjects will be distributed in each of the three cancer
categories (breast, lung, and colon), and randomized on centralized randomization lists for
each of the cancer categories and assigned a unique identification number in the temporal
order of recruitment. Using randomization with the minimization method, subjects will be
allocated to treatment or placebo, 15 each for the treatment group or the placebo group, for
a total of 30 subjects in each of the 3 cancers. This study utilizes a double-blind.
Placebo: The placebo is identical in packaging and appearance to the treatment.
Identification of placebo vs. Seigen alpha EV is by unique packaging code. Patients and
study doctors are blinded to the identification interpretation.
Treatment: Treatment will be for a maximum of 3 months. The dosage of the study supplement
is as follows: Subjects will be instructed to take 1 packet (6 grams) 3 times daily for a
total daily dosage of 3 packets (18 grams). Each packet is clearly marked for breakfast,
lunch, or supper. The contents of the packet will be dissolved in water or liquid and taken
orally morning, noon, and evening. Subjects will be required to return any unused packets
to study doctor at the end of each month.
Usual clinical tests for therapeutic monitoring of usual treatment of patient will be
In addition, quantitative and qualitative parameters will be measured at start of treatment
and at 1, 2, and 3 months:
1. Toxicity assessments using National Cancer Institute Common Toxicity Criteria (NCI
CTC): total WBC, total lymphocyte count, hemoglobin, platelet count, nausea, vomiting,
diarrhea, loss of appetite, weight loss, anorexia, urticaria, fatigue, muscle weakness
and headache. (Refer to Document 1 Toxicity Assessment)
2. Self-assessment of quality of life will be performed using European Organization for
Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3). The treating physician
will summarize the patient quality of life by using the Karnofsky performance scale.
3. Additional blood test for 10 colon CA subjects (5 treatment, 5 placebo ) Molecular
marker NFκB mediated signal transduction pathway genes (n=84) will be measured on 10
subjects with colon cancer. A sample of no less than 5 ml using PAXgene Blood RNA
Tubes (Qiagen, Cat. No. 762115) will be collected from each subject. Shipment
overnight on at least 10 lbs of ice block (blue or wet) to SuperArray Bioscience in
Frederick, MD 21704.
Baseline and repeated at one, two and three months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Change in self-rated symptoms and assessed signs
Ed Fujimoto, PhD
New Hope Medical Center
United States: Institutional Review Board
Seigen Safety Trial: Cancer