Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy

This study has been withdrawn prior to enrollment.
(FDA sent letter to IRB stating it should be done under new drug application)
Sponsor:
Information provided by (Responsible Party):
New Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00606970
First received: January 22, 2008
Last updated: May 5, 2013
Last verified: May 2013

January 22, 2008
May 5, 2013
January 2007
January 2009   (final data collection date for primary outcome measure)
Change in self-rated symptoms and assessed signs [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00606970 on ClinicalTrials.gov Archive Site
Affect on treatment results [ Time Frame: 3 months maximum ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy
Assessment of the Safety of Dietary Supplement Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy

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.

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.

Assessment:

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:

  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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Cancer
  • 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 Names:
    • Seigen Alpha EV
    • Lactobacillus fermented extract
  • 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
  • Experimental: Intervention group
    Seigen Alpha EV Treatment
    Intervention: Dietary Supplement: Seigen Alpha EV
  • Placebo Comparator: 2
    Identically packaged placebo packets taken 3x daily for 3 months maximum
    Intervention: Dietary Supplement: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eligible subjects have given written informed consent prior to participation
  • They must have a life expectancy of greater than 6 months
  • They must have biopsy confirmed primary breast, colon or lung cancer
  • They are receiving standard chemotherapy in accordance with American Society Clinical Oncology (ASCO) standards and have at least one month remaining in their chemotherapy course
  • They must have an Eastern Cooperative Oncology Group (ECOG) performance status < 2 and are being treated as outpatients.
  • Subjects must be between the ages of 18 to 75 years of age.
  • Subjects must be able to communicate in English.

Exclusion Criteria:

  • Have received radiotherapy within the last 4 weeks
  • Have acute gastrointestinal problems e.g. acute gastrointestinal infection, gastric or duodenal ulcer, history of bowel obstruction, diverticulitis, Crohn's disease, ulcerative colitis, or chronic diarrhea
  • Presence or clinical evidence of CNS metastases
  • Receiving corticosteroids
  • Have severe concomitant disease
  • Have severe dysphagia, esophagitis or xerostoma
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00606970
Seigen Safety Trial: Cancer, WIRB Study No. 1085894, WIRB Pr. No. 20062258
No
New Hope Medical Center
New Hope Medical Center
Not Provided
Study Director: Ed Fujimoto, PhD New Hope Medical Center
New Hope Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP