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Prostate Cancer: Impact Of Fat And Flaxseed - Modified Diets


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Prostate Cancer: Impact Of Fat And Flaxseed - Modified Diets


OBJECTIVES:

- Compare tumor proliferation in patients with newly diagnosed prostate cancer eating
fat- and/or flaxseed-modified diets.

- Compare differences in histopathological markers associated with prostate cancer (rates
of apoptosis, extent of high-grade prostatic intraepithelial neoplasia) among patients
in these diet groups.

- Compare changes in serum prostate specific antigen among patients in these diet groups.

- Compare changes in hormone-related factors (total serum testosterone and free androgen
index, insulin-like growth factor [IGF], and IGF-binding protein-3) among patients in
these diet groups.

- Compare the effects of diet on nutritional biomarkers (levels of lignans in the urine
and ejaculate, fatty acid profiles of erythrocytes and prostatic tissue) in these
patients.

- Determine associations between dietary modification and changes in dietary biomarkers,
hormonal intermediates, and study endpoints in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to Gleason score
(less than 7 vs at least 7) and race (black vs non-black). Patients are randomized to 1 of 4
diet groups.

- Arm I (Flaxseed-supplemented diet): Patients are instructed to incorporate ground
flaxseed into their daily diets.

- Arm II (Low-fat diet): Patients are instructed on ways to achieve a diet with no
greater than 20% of total energy from dietary fat.

- Arm III (Flaxseed-supplemented, low-fat diet): Patients are instructed as in arm I and
arm II.

- Arm IV (Control diet): Patients are contacted weekly, but do not receive dietary
counseling until after surgery.

All patients ingest the diets for at least 3 weeks and complete diet diaries until surgery.
After surgery, all patients receive dietary counseling.

PROJECTED ACCRUAL: A total of 160 patients (40 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer

- At least 3 weeks until planned prostatectomy (24 days between day 1 visit and
surgery)

- Current diet that provides more than 30% of calories from fat

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Mentally competent

- Able to speak and write English

- Must have telephone access

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- No concurrent hormonal therapy

Radiotherapy

- Not specified

Surgery

- At least 2 weeks since prior prostate biopsy

Other

- At least 7 days since prior antibiotics

- No prior therapy for prostate cancer

- No concurrent dietary supplements initiated within the past 3 months or anticipated
to begin during study except standard multivitamin/mineral preparations (e.g.,
One-A-Day, Theragran, or Centrum) that do not supply > 100% of the recommended daily
allowance of any vitamin or mineral

- No other concurrent neoadjuvant therapies

- No other concurrent flaxseed consumption

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy

Safety Issue:

No

Principal Investigator

Wendy Demark-Wahnefried, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

Pro00008602

NCT ID:

NCT00049309

Start Date:

January 2003

Completion Date:

May 2006

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570