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Evaluation of the Efficacy of a Combination of Micronutrients (Vitamin A, C, E, Selenium and Zinc) in Reducing the Incidence of Colorectal Metachronous Adenomas. A Double Blind, Phase III, Randomized, Placebo-controlled Trial


Phase 3
25 Years
75 Years
Not Enrolling
Both
Colorectal Adenomas

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Trial Information

Evaluation of the Efficacy of a Combination of Micronutrients (Vitamin A, C, E, Selenium and Zinc) in Reducing the Incidence of Colorectal Metachronous Adenomas. A Double Blind, Phase III, Randomized, Placebo-controlled Trial


Adenomatous polyps (or adenoma) are benign lesions of the large bowel that are frequent in
people aged 60 or more: about one in four of them has at least one adenoma. In time,
adenoma could progress to cancer. Even though only a small rate of adenomas will develop
into cancer almost 70-80% of colorectal cancer origin from an adenoma and colorectal cancer
is one of the most frequent malignant tumors in the western world. Several epidemiological
studies showed that subjects who had low intake and/or low blood levels of selenium were at
increased risk of developing colorectal cancer.


Inclusion Criteria:



- age 25-75 years

- at least one histologically confirmed adenoma endoscopically removed from the large
bowel resulting in a polyp-free colon-rectum (clean colon).

Exclusion Criteria:

- polypectomy performed more than 6 months before enrolment in the trial

- history of Familial Adenomatous Polyposis

- inflammatory bowel disease

- adenoma with invasive carcinoma

- ten or more adenomas

- large sessile adenoma (3 cm or more

- colorectal resection

- invasive cancer at any site

- life-threatening and/or chronic heart, liver or kidney diseases

- current use of vitamin or calcium supplements

- mental disability

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations

Outcome Time Frame:

five years

Safety Issue:

No

Principal Investigator

Luigina A Bonelli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genova - Italy

Authority:

Italy: AIFA

Study ID:

IST-1988

NCT ID:

NCT01437826

Start Date:

March 1988

Completion Date:

June 1996

Related Keywords:

  • Colorectal Adenomas
  • chemoprevention
  • colorectal cancer
  • metachronous adenoma
  • randomized trial
  • Adenoma

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