Personalized Prevention of Colorectal Cancer Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 7/25/2018 |
| Start Date: | August 2010 |
| End Date: | January 2020 |
Investigational Nutrigenetic Studies for Cancer Prevention
Colorectal cancer is the fourth most common incident cancer and the second most common cause
of cancer death in the United States, with approximately 150,000 new cases and 57,000 deaths
per year. High calcium intake and magnesium may protect against colorectal cancer and
adenoma, however, results have been inconsistent. We found that genetic makeup, associated
with magnesium absorption and re-absorption, significantly interacted with the calcium and
magnesium ratio in relation to the both adenomatous and hyperplastic polyps. Participants who
carried at least one 1482Ile allele (G->A)of TRPM7 and who consumed diets with a high
calcium/magnesium ratio were at a higher risk of adenoma and hyperplastic polyps than were
participants who did not carry the polymorphism. We hypothesize that the reduction in the
dietary Ca/Mg ratio may change the markers directly related to tumorigenesis. The primary
aims of this study are to conduct a randomized placebo-controlled intervention trial to test
whether reducing the Ca/mg intake ratio through magnesium supplementation has effects on the
related biomarkers. We will also examine whether the effect of modulating Ca/Mg intake ratio
may be more pronounced among those who carry the 1482Ile allele compared those who don't
carry the 1482Ile allele. Results from our study will help to identify people at a high risk
of colorectal adenoma and to develop personalized strategies to prevent occurrence of
colorectal adenoma, and thus, colorectal cancer through dietary change or nutritional
fortification.
of cancer death in the United States, with approximately 150,000 new cases and 57,000 deaths
per year. High calcium intake and magnesium may protect against colorectal cancer and
adenoma, however, results have been inconsistent. We found that genetic makeup, associated
with magnesium absorption and re-absorption, significantly interacted with the calcium and
magnesium ratio in relation to the both adenomatous and hyperplastic polyps. Participants who
carried at least one 1482Ile allele (G->A)of TRPM7 and who consumed diets with a high
calcium/magnesium ratio were at a higher risk of adenoma and hyperplastic polyps than were
participants who did not carry the polymorphism. We hypothesize that the reduction in the
dietary Ca/Mg ratio may change the markers directly related to tumorigenesis. The primary
aims of this study are to conduct a randomized placebo-controlled intervention trial to test
whether reducing the Ca/mg intake ratio through magnesium supplementation has effects on the
related biomarkers. We will also examine whether the effect of modulating Ca/Mg intake ratio
may be more pronounced among those who carry the 1482Ile allele compared those who don't
carry the 1482Ile allele. Results from our study will help to identify people at a high risk
of colorectal adenoma and to develop personalized strategies to prevent occurrence of
colorectal adenoma, and thus, colorectal cancer through dietary change or nutritional
fortification.
Inclusion Criteria:
- Hyperplastic polyp or/and Adenoma cases
- Polyps free participants with any of the following high risk of colorectal polyps or
cancer: (1) family history of colorectal cancer or polyps; (2) current cigarette
smoker; (3) obesity (BMI≥30 kg/m2); (4) low intake of fiber (lowest fiber intake
quartile: daily intake <16.6g); (5) high intake of red meat and well-done or processed
meat (mutageneity index ≥5852).
- Participants from the TCPS (IRB # 090235), the TIARS (IRB # 090235), from Vanderbilt
University Hospital or from other resources
- Consent to be contacted for future studies in TCPS (IRB # 020462), TIARS (IRB#090235)
- Participants with a calcium intake ≥ 700 mg/day measuring with 24 hour dietary recalls
- Participants with a calcium intake < 2000 mg/day measuring with 24 hour dietary
recalls
- Participants with a calcium/magnesium intake ratio > 2.6
- Participants with known genotype for Thr1482Ile polymorphism in TRPM7
- Will live in Nashville or surrounding area in the next 6 months
Exclusion Criteria:
- Intolerance to magnesium glycinate or microcrystalline cellulose (placebo)
- Chronic renal diseases and hepatic cirrhosis
- Chronic ischemic heart disease with unstable angina, chronic heart failure at class
III or IV and acute myocardial infarction in the last 6 months
- Chronic diarrhea
- Current breastfeeding
- Current or planned pregnancy
- Type I diabetes mellitus
- Pituitary dwarfism
- Use of digoxin and licorice
- Current use of blood anticoagulant drugs such as Dicumarol(Warfarin), Clopidogrel
(Plavix), Prasugrel HCl (Efficent), Ticlopidine (Ticlid), Lovenox (Enoxaparin),
Fragmin (Dalteparin), Innohep (Tinzaparin), Eptifibatide (Integrilin), Tyrofiban
(Aggrastat), and Abciximab (Reopro)
- Current use of lithium carbonate therapy (Eskalith, Lithobid, Lithonate, Lithotabs,
Apo-Lithium carbonate, Apo-Lithium carbonate SR, Carbolth, Duralith, PMS-Lithium
carbonate, PMS-Lithium citrate)
- Individuals with a history of colon resection or colectomy due to any reason
- Individuals with any history of cancer other than non-melanoma skin cancer
- Individual with history of any organ transplantation
- Individual with a history of gastric bypass due to any reason
- Individuals with Inflammatory bowel disease
- Individuals if creatinine clearance is < 50
- Currently institutionalized
- Homeless individual (address, telephone etc.)
- Unable to provide informed consent
- Any condition that in the opinion of the investigator raises concerns about protocol
compliance
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-343-3437
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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