Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy
|ClinicalTrials.gov Identifier: NCT00606970|
Recruitment Status : Withdrawn (FDA sent letter to IRB stating it should be done under new drug application)
First Posted : February 5, 2008
Last Update Posted : May 7, 2013
Project: Assessment of the safety of dietary supplement lactobacillus fermented extract in cancer patients undergoing chemotherapy
Nausea and vomiting are significant causes of nutritional depletion and result in further deterioration of the physical and mental status. Support of gastrointestinal function may alleviate nausea and vomiting from chemotherapy and will not only reduce the discomfort experienced by the patient but will allow better tolerance of the treatment. This study will assess orally administered Seigen alpha EV during chemotherapy for its safety and effects on the nutritional depletion deriving from the chemotherapy. It will also look at its effect on the immune system in patients undergoing chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Dietary Supplement: Seigen Alpha EV Dietary Supplement: Placebo Comparator||Early Phase 1|
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 performed.
In addition, quantitative and qualitative parameters will be measured at start of treatment and at 1, 2, and 3 months:
- 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)
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Assessment of the Safety of Dietary Supplement Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy|
|Study Start Date :||January 2007|
|Primary Completion Date :||January 2009|
|Study Completion Date :||December 2009|
Experimental: Intervention group
Seigen Alpha EV Treatment
Dietary Supplement: Seigen Alpha EV
Orally administered Seigen Alpha EV, 1 packet (6 grams)3 times daily, for maximum of 3 months. Each packet is clearly marked for breakfast, lunch, or supper. The contents are to be dissolved in water or liquid and taken orally with meal. Subjects will be required to return any unused packets to study doctor at end of each month.
Other Name: Lactobacillus fermented extract
Placebo Comparator: 2
Identically packaged placebo packets taken 3x daily for 3 months maximum
Dietary Supplement: Placebo Comparator
Identically packaged placebo packets (each 6 grams) taken 3x daily with meals for 3 months maximum.
Other Name: Placebo packaged identically to Seigen Alpha EV
- Change in self-rated symptoms and assessed signs [ Time Frame: 3 months ]
- Affect on treatment results [ Time Frame: 3 months maximum ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606970
|Study Director:||Ed Fujimoto, PhD||New Hope Medical Center|