Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy

May 5, 2013 updated by: New Hope Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Placebo packaged identically to Seigen Alpha EV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in self-rated symptoms and assessed signs
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Affect on treatment results
Time Frame: 3 months maximum
3 months maximum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Hope Medical Center

Investigators

  • Study Director: Ed Fujimoto, PhD, New Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 5, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Seigen Safety Trial: Cancer
  • WIRB Study No. 1085894
  • WIRB Pr. No. 20062258

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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