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Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy

NCT00606970 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2013-05-07

No results posted yet for this 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.

Conditions

Interventions

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.

DIETARY_SUPPLEMENT

Placebo Comparator

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

Sponsors & Collaborators

  • New Hope Medical Center

    lead NETWORK

Principal Investigators

  • Ed Fujimoto, PhD · New Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-01-31
Completion
2009-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00606970 on ClinicalTrials.gov