Diet Effect on Cancer Treatment Outcome

Study Overview
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Brief Summary
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The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.

Detailed Description
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The study will be evaluated during a double blind, placebo-controlled evaluation of the effect diet has on the response of patients taking N-111 who are on a vegetarian diet vs a non-vegetarian diet or a placebo. This will involve assessing the patients progress or lack thereof over a 3-month period of time as outlined in Outcome Measures section below.

Official Title
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A Study on the Effect Diet Has Affecting the Response of Patients Taking N-111 Who Are on a Vegetarian Diet vs a Non-vegetarian Diet or a Placebo

Conditions
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Cancer Breast, Cancer Prostate

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement: N-111
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers. Prostate cancer as determined by a Transrectal Biopsy with associated Prostate- specific antigen blood work. Exclusion Criteria: •Patients without the positive diagnosis of breast or prostate cancer.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized interventional parallel study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vegetarian N-111 group<br>The group will use a vegetarian diet with the active compactor N-111. | Dietary Supplement: Dietary Supplement: N-111<br>* Dietary supplement N-111<br>|
| Active Comparator: Non-vegetarian N-111 group.<br>The group will use a non-vegetarian diet with the active compactor N-111. | Dietary Supplement: Dietary Supplement: N-111<br>* Dietary supplement N-111<br>|
| Placebo Comparator: Vegetarian placebo group<br>The group will use a vegetarian diet with a placebo. | Other: Placebo<br>* Dietary placebo<br>|
| Placebo Comparator: Non-vegetarian placebo control group<br>The group will use a non-vegetarian diet with a placebo. | Other: Placebo<br>* Dietary placebo<br>|
| No Intervention: Vegetarian control group<br>The group will use a vegetarian diet without the active compactor N-111 or the placebo. | |
| No Intervention: Non-vegetarian control group<br>he group will use a non-vegetarian diet without the active compactor N-111 or the placebo. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active Comparator: Vegetarian N-111 group | Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3. | End of month 3. | 
| Active Comparator: Non-vegetarian N-111 group. | Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3. | End of month 3. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placebo Comparator: Vegetarian placebo group | Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3. | End of month 3. | 
| Placebo Comparator: Non-vegetarian placebo control group | Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3. | End of month 3. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer