Clinical Trial: Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Trial to Explore the Effect of Oral Omega 3 Fatty Acids on Atrophic Vaginitis in Postmenopausal Breast Cancer Survivors

Brief Summary: This randomized double-blind clinical trial studied the effect of oral omega-3 fatty acid on atrophic vaginitis in postmenopausal breast cancer survivors (N=52). Omega-3 fatty acid may reduce inflammation and improve vaginal symptoms in postmenopausal breast cancer survivors.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To examine the ability of oral omega-3 fatty acids to improve symptoms of atrophic vaginitis as reported by postmenopausal breast cancer survivors as compared to survivors not taking omega 3.

II.To examine the ability of oral omega-3 fatty acids to decrease inflammation related to atrophic vaginitis in postmenopausal breast cancer survivors as compared to survivors not taking omega 3.

III. To examine the ability of oral omega-3 fatty acids to uptake systemically and to validate adherence; these measures will be compared to demographic data including body mass index to observe if differences exist in postmenopausal breast cancer survivors vs. those not taking omega 3.

IV. To examine the effect of oral omega 3 fatty acids as compared to placebo of dietary supplement on serum female hormone levels in postmenopausal breast cancer survivors.

V. To examine cytokine levels in women taking oral omega 3 fatty acids as compared to women not taking omega 3 to determine effect.

OUTLINE: Patients were randomized to 1 of 2 treatment arms.

ARM I: Patients received 3.5g omega-3 fatty acid orally (PO) daily for 6 months.

ARM II: Patients received placebo of dietary supplement (7 capsules) PO daily for 6 months.


Sponsor: Ohio State University Comprehensive Cancer Center

Current Primary Outcome: Explore the ability of oral omega 3 fatty acids to improve symptoms of atrophic vaginitis as self-reported by postmenopausal breast cancer survivors that took omega 3 vs. those survivors who did not take omega 3. [ Time Frame: From baseline to 3 and 6 months ]

Self-reported measures included the Urogenital Atrophy Questionnaire, Brief Pain Inventory, Menopause Rating Scale, and Female Sexual Function Index. These measures were compared in women assigned to omega 3 fatty acids vs. women assigned to placebo of dietary supplement.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Explore the ability of oral omega 3 fatty acids to decrease inflammation related to atrophic vaginitis in postmenopausal breast cancer survivors who took omega 3 fatty acids as compared to those survivors who did not take omega 3. [ Time Frame: From baseline to 3 and 6 months ]
    This was measured by self-reported pain to touch during gynecological examination, self-reported vaginal dryness, pain, or irritation, wet prep results (presence or absence of yeast), pH, and parabasal layer that indicated a shift to less inflamed tissue, and gynecologic examination results.
  • Determine level of omega 3 uptake in those who took omega 3 vs. those who took placebo of dietary supplement by using tested serum levels of omega 3 fatty acids in all participants. [ Time Frame: From baseline to 3 and 6 months ]
    Tested serum levels to evaluate the level of omega 3 fatty acids in women assigned to omega 3 vs. women assigned to placebo of dietary supplement to validate adherence and systemic uptake as compared to self-reported adherence and dietary records.
  • Measure if effects exist from omega 3 fatty acids by using tested serum hormone levels in all participants. [ Time Frame: From baseline to 3 and 6 months ]
    The investigators tested serum hormone levels in women assigned to omega 3 fatty acids vs. women assigned to placebo of dietary supplement to determine the effect, if any, of omega 3 fatty acids.
  • Determine if an effect existed in women that took omega 3 fatty acids by using tested cytokine levels in all participants. [ Time Frame: From baseline to 3 and 6 months ]
    Cytokine levels in women taking oral omega 3 fatty acids were tested and compared to cytokine levels in women not taking oral omega 3 fatty acids as compared to those women who did not take omega 3 fatty acids..


Original Secondary Outcome: Same as current

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: August 19, 2013
Date Started: August 2010
Date Completion:
Last Updated: May 26, 2014
Last Verified: May 2014