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WithdrawnNCT00606970Updated May 7, 2013

Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy

An Early Phase 1 interventional study of Seigen Alpha EV and Placebo Comparator in Cancer, sponsored by New Hope Medical Center. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-05-07.

Sponsored by New Hope Medical Center · Early Phase 1, Interventional, and Supportive care

Why this study was withdrawn
FDA sent letter to IRB stating it should be done under new drug application
Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Cancer

Keywords

  • Chemotherapy
  • Breast Cancer
  • Colon Cancer
  • Lung Cancer
03

In context

Lead sponsor

This is the only study on the registry with New Hope Medical Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intervention group

    Seigen Alpha EV Treatment

    Dietary Supplement: Seigen Alpha EV

  • Placebo comparator
    2

    Identically packaged placebo packets taken 3x daily for 3 months maximum

    Dietary Supplement: Placebo Comparator

Interventions

  • Dietary supplementSeigen 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.

    Also known as: Lactobacillus fermented extract

  • Dietary supplementPlacebo Comparator

    Identically packaged placebo packets (each 6 grams) taken 3x daily with meals for 3 months maximum.

    Also known as: Placebo packaged identically to Seigen Alpha EV

06

What researchers measure

Primary outcomes

  1. Change in self-rated symptoms and assessed signs

    Time frame: 3 months

Secondary outcomes

  1. Affect on treatment results

    Time frame: 3 months maximum

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00606970
Lead sponsor
New Hope Medical Center
Responsible party
Sponsor
First posted
Feb 5, 2008
Start date
Jan 2007
Primary completion
Jan 2009
Completion
Dec 2009
Last update
May 7, 2013

Study contacts

Ed Fujimoto, PhD
study director · New Hope Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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