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An in Vivo Proof of Principle Trial to Determine Whether the Nutritional Supplement Conjugated Linoleic Acid (CLA, Clarinol™) Can Modulate the Lipogenic Pathway in Breast Cancer Tissue


Phase 0
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

An in Vivo Proof of Principle Trial to Determine Whether the Nutritional Supplement Conjugated Linoleic Acid (CLA, Clarinol™) Can Modulate the Lipogenic Pathway in Breast Cancer Tissue


Inclusion Criteria:



- All study patients must have histologically confirmed invasive adenocarcinoma of the
breast. Their breast cancer must be resectable clinical stage I or II breast cancer
as defined by the current AJCC TNM Staging System (Greene FL, Page DL, Fleming ID, et
al.: editors. AJCC cancer staging manual, 6th edition. New York: Springer; 2002).

- All patients must be able to and give informed consent indicating they are aware of
the investigational nature of this treatment, prior to entry into the study.

- All subjects must be Age >18 years.

- All subject must have adequate hepatic and renal function documented prior to study
entry to include: hepatic transaminases (AST or ALT) ≤ 1.5 times the upper limits of
normal, total bilirubin ≤ 1.5 times the upper limits of normal, serum creatinine ≤
1.5 times the upper limit of normal or eCRCl ≥ 60 mL/min.

Exclusion criteria:

- Patients who have received prior or be receiving radiation therapy for their breast
cancer will be excluded.

- Patients who have received prior chemotherapy or receiving chemotherapy or hormonal
therapy for their breast cancer will not be included.

- Women must be surgically sterilized or post-menopausal or women of childbearing
potential must be using an adequate method of contraception. Women of childbearing
potential must be using at least one of the following: oral, implanted, injectable
contraceptive hormones, or mechanical products such as an intrauterine device or
barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing
abstinence or have a partner that is sterile (e.g., vasectomy). Women of
childbearing potential must have a negative serum or urine pregnancy test within 72
hours prior to start of study therapy. Women who are pregnant or breast-feeding and
women of childbearing potential not using an adequate method of birth control will be
excluded.

- Patients with gastrointestinal abnormalities including: inability to take oral
medication, requirement for intravenous alimentation, or prior surgical procedures
affecting nutrient /drug absorption will be excluded.

- A serious uncontrolled medical disorder or active infection which would impair their
ability to receive study treatment will be excluded. Significant cardiac disease,
including uncontrolled high blood pressure, unstable angina, and congestive heart
failure, myocardial infarction within the previous 3 months or serious cardiac
arrhythmias will be excluded. Dementia or significantly altered mental status that
would prohibit the understanding or rendering of informed consent and compliance with
the requirements of this protocol will be excluded.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

To determine whether CLA consumption suppresses expression of markers of lipogenesis (Spot 14, FASN, LPL, Ki67 and apoptotic index ) in breast cancer tissue in vivo.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Margit M McGowan, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

D0906

NCT ID:

NCT00908791

Start Date:

May 2009

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Conjugated Linoleic Acid
  • Proof of Principle
  • Lipogenic Pathway
  • Clarinol
  • Breast Neoplasms

Name

Location

Dartmouth Hitchcock Medical Center, Norris Cotton Cancer CenterLebanon, New Hampshire  03756