Ductal Breast Carcinoma in SituPhase 2NCT02150525
Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors
A Phase 2 study testing omega-3 fatty acid and Questionnaire administration in people with Ductal Breast Carcinoma in Situ and Breast Cancer, Stage I, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Ductal Breast Carcinoma in Situ, Breast Cancer, Stage I, Breast Cancer, Stage II
- What is being tested?
- omega-3 fatty acid and Questionnaire administration
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center, Comprehensive Breast Center
Columbus, Ohio, 43210
About this study
Official title: A Randomized Trial to Explore the Effect of Oral Omega 3 Fatty Acids on Atrophic Vaginitis in Postmenopausal Breast Cancer Survivors
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Ductal Breast Carcinoma in Situ, Breast Cancer, Stage I, Breast Cancer, Stage II, Breast Cancer, Stage III
- Being tested
- omega-3 fatty acid, placebo, Questionnaire administration
- Keywords
- breast cancer, vaginal dryness, dyspareunia, genital irritation
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidDietary supplement
Also called fish oil, n-3 fatty acid, O3FA, PUFAs
Given PO (by mouth) daily
placeboOther
Also called PLCB
Given PO(by mouth)daily
Questionnaire administrationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm I (oral omega-3 fatty acid) | Experimental | 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. Receives: Dietary Supplement: omega-3 fatty acid; Behavioral: Questionnaire administration |
| Arm II (placebo) | Placebo comparator | Patients received equivalent, matched oral placebo (seven capsules) daily for 6 months. Questionnaire administration, pills counts, and medication diaries were collected at monthly intervals. Receives: Other: placebo; Behavioral: Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: From baseline to 3 and 6 months
Secondary outcomes (4)
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.
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.
Measured: From baseline to 3 and 6 months
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.
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.
Measured: From baseline to 3 and 6 months
Measure if effects exist from omega 3 fatty acids by using tested serum hormone levels in all participants.
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.
Measured: From baseline to 3 and 6 months
Determine if an effect existed in women that took omega 3 fatty acids by using tested cytokine levels in all participants.
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..
Measured: From baseline to 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startAug 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Breast Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Lester, PhD, CRNP, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150525
- Sponsor's protocol ID
- OSU-09145
- Other IDs
- NCI-2013-00068
- Status last verified
- Aug 2018
- First submitted
- 19 Aug 2013
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Explore the Effect of Oral Omega 3 Fatty Acids on Atrophic Vaginitis in Postmenopausal Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02150525
- Acronym / sponsor ID
- OSU-09145
- Conditions
- Ductal Breast Carcinoma in Situ, Breast Cancer, Stage I, Breast Cancer, Stage II, Breast Cancer, Stage III
- Keywords
- breast cancer, vaginal dryness, dyspareunia, genital irritation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
PRIMARY OBJECTIVES:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (oral omega-3 fatty acid) | Experimental | Dietary Supplement: omega-3 fatty acid, Behavioral: Questionnaire administrationPatients received 3.5g oral omega-3 fatty acid daily for 6 months. Questionnaire administration, pills counts, and medication diaries were collected at monthly intervals. |
| Arm II (placebo) | Placebo comparator | Other: placebo, Behavioral: Questionnaire administrationPatients received equivalent, matched oral placebo (seven capsules) daily for 6 months. Questionnaire administration, pills counts, and medication diaries were collected at monthly intervals. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 fatty acidAlso: fish oil, n-3 fatty acid, O3FA, PUFAsGiven PO (by mouth) daily | Dietary supplement | Arm I (oral omega-3 fatty acid) |
| placeboAlso: PLCBGiven PO(by mouth)daily | Other | Arm II (placebo) |
| Questionnaire administrationMeasures 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). | Behavioural | Arm I (oral omega-3 fatty acid), Arm II (placebo) |
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Lester, PhD, CRNP principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing omega-3 fatty acid and Questionnaire administration in people with Ductal Breast Carcinoma in Situ and Breast Cancer, Stage I, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.