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Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02150525
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Ductal Breast Carcinoma in Situ Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Dietary Supplement: omega-3 fatty acid Other: placebo Behavioral: Questionnaire administration Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Trial to Explore the Effect of Oral Omega 3 Fatty Acids on Atrophic Vaginitis in Postmenopausal Breast Cancer Survivors
Actual Study Start Date : August 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (oral omega-3 fatty acid)
Patients received 3.5g oral omega-3 fatty acid daily for 6 months. Questionnaire administration, pills counts, and medication diaries were collected at monthly intervals.
Dietary Supplement: omega-3 fatty acid
Given PO (by mouth) daily
Other Names:
  • fish oil
  • n-3 fatty acid
  • O3FA
  • PUFAs

Behavioral: Questionnaire administration
Measures of self-reported outcomes: Self-reported symptoms will be documented with the Urogenital Atrophy Questionnaire (UAQ), Menopausal Rating Scale (MRS), Female Sexual Function Index (FSFI), Center for Epidemiological Studies Short Depression Scale (CES-D 10), and Brief Pain Inventory (BPI).

Placebo Comparator: Arm II (placebo)
Patients received equivalent, matched oral placebo (seven capsules) daily for 6 months. Questionnaire administration, pills counts, and medication diaries were collected at monthly intervals.
Other: placebo
Given PO(by mouth)daily
Other Name: PLCB

Behavioral: Questionnaire administration
Measures of self-reported outcomes: Self-reported symptoms will be documented with the Urogenital Atrophy Questionnaire (UAQ), Menopausal Rating Scale (MRS), Female Sexual Function Index (FSFI), Center for Epidemiological Studies Short Depression Scale (CES-D 10), and Brief Pain Inventory (BPI).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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..



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman with a history of breast cancer, stage 0, I, II, or III
  • At least 12 months from definitive surgical procedure (i.e. lumpectomy or mastectomy)
  • At least 3 months from completion of chemotherapy
  • Postmenopausal, defined as no menstrual cycle for 12 consecutive months, or surgical menopause
  • Have one or more stated symptoms of atrophic vaginitis, such as vaginal dryness, genital irritation/itching, genital pain, and/or dyspareunia
  • No current use of estrogen replacement therapy
  • If recent use of estrogen replacement therapy, off at least three months
  • No current use of estradiol-releasing vaginal ring or estradiol vaginal tablets; if recent use of these products, off at least 3 consecutive months
  • No evidence of disease (NED), any cancer other than breast cancer
  • No current use of oral omega 3 fatty acids or Vitamin E; if recent consistent use of these products, off at least six months; if sporadic use of these products, off at least 3 consecutive months
  • May be taking oral anti-estrogens or aromatase inhibitors, and/or biologic therapy
  • Must be willing to undergo venipuncture at 0, 3, and 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • No history of a bleeding tendency
  • No history of uncontrolled hypertension, heart disease or stroke
  • Hemoglobin > 10 g/dL
  • Hematocrit > 30%
  • White blood count > 3.5 K/uL
  • Platelet count > 100,000/mm^3
  • Fasting serum glucose < 115 mg/dL
  • Total bilirubin < 1.6 mg/dL
  • Transaminases alanine aminotransferase(ALT)and aspartate aminotransferase (AST)< 1.5 x ULN (upper limit of normal)

Exclusion Criteria:

  • Metastatic malignancy of any kind
  • Ongoing chemotherapy or radiation therapy (ongoing hormonal therapy and/or biologic therapy are allowed)
  • History of pelvic or genital radiation therapy
  • Use of Coumadin or other anticoagulants
  • Known, active pelvic, vaginal, or urinary tract infections
  • Current use of hormone replacement therapy, either systemic or local
  • Uncontrolled co-morbidities including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable hypertension
  • Psychiatric illness/social situation that would limit adherence to study requirements
  • Consistent use of omega-3 fatty acid concentrates or capsules within the 6 months prior to entry on the study
  • Known sensitivity or allergy to fish oil or omega 3 fish products
  • Pregnant or nursing women
  • Subjects who cannot give an informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150525


Locations
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United States, Ohio
The Ohio State University Medical Center, Comprehensive Breast Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Joanne Lester, PhD, CRNP Ohio State University

Additional Information:
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Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02150525     History of Changes
Other Study ID Numbers: OSU-09145
NCI-2013-00068 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ohio State University Comprehensive Cancer Center:
breast cancer
vaginal dryness
dyspareunia
genital irritation
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Vaginitis
Atrophic Vaginitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Vaginal Diseases
Genital Diseases, Female