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Sponsored by: |
New Hope Medical Center |
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Information provided by: | New Hope Medical Center |
ClinicalTrials.gov Identifier: | NCT00606970 |
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.
Condition | Intervention | Phase |
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Cancer |
Dietary Supplement: Seigen Alpha EV Dietary Supplement: Placebo Comparator |
Phase 0 |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assessment of the Safety of Dietary Supplement Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy |
Estimated Enrollment: | 90 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Intervention group: Experimental
Seigen Alpha EV Treatment
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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.
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2: Placebo Comparator
Identically packaged placebo packets taken 3x daily for 3 months maximum
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Dietary Supplement: Placebo Comparator
Identically packaged placebo packets (each 6 grams) taken 3x daily with meals for 3 months maximum.
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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:
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel Royal, DO, J.D. | 702-476-0000 |
United States, Nevada | |
New Hope Medical Center | Recruiting |
Henderson, Nevada, United States, 89074 | |
Contact: Daniel F Royal, DO, HMD, JD 702-476-0000 droyal@newhopemedical.org | |
Contact: Daniel Royal, DO, JD 702-4760000 | |
Principal Investigator: Daniel Royal, DO, JD | |
Comprehensive Cancer Centers of Nevada | Recruiting |
Las Vegas, Nevada, United States, 89148 | |
Contact: Paul Michael, MD 702-952-1251 | |
Principal Investigator: Paul Michael, MD |
Study Director: | Daniel F Royal, DO, HMD, JD | New Hope Medical Center |
Responsible Party: | New Hope Medical Center ( Daniel Royal, D.O. J.D., Principal Investigator ) |
Study ID Numbers: | Seigen Safety Trial: Cancer, WIRB Study No. 1085894, WIRB Pr. No. 20062258 |
Study First Received: | January 22, 2008 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00606970 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chemotherapy Breast Cancer Colon Cancer Lung Cancer |
Lung Neoplasms Breast Neoplasms Acidophilus |