Status:
WITHDRAWN
Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy
Lead Sponsor:
New Hope Medical Center
Conditions:
Cancer
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00606970
Start Date
January 1 2007
End Date
December 1 2009
Last Update
May 7 2013
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