Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246727
Status:
UNKNOWN
Last Update Posted:
2011-10-31
First Post:
2005-10-27
Brief Title:
Effects of Selected Vegetable and Herb Mix SV on Advanced Non-small Cell Lung Cancer
Sponsor:
Sun Farm Corporation
Organization:
Sun Farm Corporation
Study Overview
Official Title:
Study 1 Effects of a Dietary Supplement SV on Advanced NSCLC Treated With Chemotherapy A Randomized Double Blind Placebo Controlled Study Study 2 Effects of a Dietary Supplement SV on Advanced NSCLC Treated With Best Supportive Care A Randomized Double Blind Placebo Controlled Study
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of these two studies is to test the hypothesis that the daily ingestion of a dietary supplement Selected Vegetables and Herbs Mix SV which consists of non-toxic botanicals containing known anti-cancer andor immune enhancing components may prolong the survival time of stage IIIBIV non-small cell lung cancer NSCLC patients Either SV or placebo will be added to their daily diet in a double-blind randomized fashion so that there will be 2 chances out of 3 of receiving SV and 1 chance out of 3 of receiving placebo
Study 1 For newly diagnosed patients who will be receiving or have received less than 4 weeks of a standard chemotherapy regimen
Study 2 For those who have stopped or refuse standard chemotherapy but will receive best supportive care
Study 1 For newly diagnosed patients who will be receiving or have received less than 4 weeks of a standard chemotherapy regimen
Study 2 For those who have stopped or refuse standard chemotherapy but will receive best supportive care
Detailed Description:
Carcinoma of the lung is the leading cause of cancer related deaths in North America Non-small Cell Lung Cancer NSCLC causes the death of more than 400000 patients annually in the US and Western Europe The benefit of conventional therapies such as chemotherapy and radiotherapy for unresectable stage IIIB and IV NSCLC patients is small the generally accepted median survival time of late stage patients has remained 4-6 months in the Supportive Care group and 6-9 months in the chemotherapy treatment group the one-year survival is about 20 Ideal Treatment for NSCLC The toxicity of chemotherapy and side-effects of radiotherapy to the quality of life of the patients have been a major issue in cancer treatments It has been significant enough that many patients choose to forgo standard treatments Furthermore the current chemotherapy for advanced NSCLC is quite expensive about 50000 to 100000 per year Therefore an ideal treatment for advanced NSCLC patients should meet the following criteria
1 Prolong patient survival
2 Minimal toxicity
3 Improvement in the patients quality of life
4 Relatively inexpensive A phytomix consisting of selected vegetables and herbs appears to meet all these criteria The phytomix consists of 19 vegetable and herbs in a highly concentrated form These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities Each batch of raw materials has gone through a very strict quality control QC scheme to make sure the product meets our QC standards and devoid of deleterious contaminations such as heavy metals pesticides aflatoxin and microorganisms The manufacturing process is tightly controlled to ensure batch-to-batch consistency The final product a 20 gram freeze-dried powder is sealed in a pouch In our previous studies patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect
The Objectives of the proposed studies are to evaluate the benefits and adverse reactions of adding SV to the daily diet of cancer patients who are willing to undergo the chemotherapy Study 1 or those who refuse chemotherapy Study 2
1 Prolong patient survival
2 Minimal toxicity
3 Improvement in the patients quality of life
4 Relatively inexpensive A phytomix consisting of selected vegetables and herbs appears to meet all these criteria The phytomix consists of 19 vegetable and herbs in a highly concentrated form These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities Each batch of raw materials has gone through a very strict quality control QC scheme to make sure the product meets our QC standards and devoid of deleterious contaminations such as heavy metals pesticides aflatoxin and microorganisms The manufacturing process is tightly controlled to ensure batch-to-batch consistency The final product a 20 gram freeze-dried powder is sealed in a pouch In our previous studies patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect
The Objectives of the proposed studies are to evaluate the benefits and adverse reactions of adding SV to the daily diet of cancer patients who are willing to undergo the chemotherapy Study 1 or those who refuse chemotherapy Study 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None