Hot FlashesPhase 2NCT00275704
Flaxseed for the Treatment of Hot Flashes
A Phase 2 study testing Flaxseed in people with Hot Flashes, run by Mayo Clinic at 1 site in United States.
Trial summary
Flaxseed, a phytoestrogen, is a natural food supplement rich in plant ligands, which have a very weak estrogen effect. In this study, flaxseed is being evaluated in regard to its capacity to safely and effectively treat hot flashes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Flaxseed
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jun 2006
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Inclusionary Criteria:
- Age greater than or equal to 18 years
- Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer.
- Bothersome hot flashes (defined by occurenece of greater than or equal to 14 times per week and of sufficient severity to make the patient desire therapeutic intervention).
- Presence of hot flashes for greater than or equal to 1 month prior to study entry.
- Life expectancy greater than or equal to 6 months.
- ECOG Performance Status (PS) 0 or 1 (see Appendix VIII)
Exclusionary Criteria/Contraindications
- Any of the following current (less than or equal to 4 weeks) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but patient must have been on a constant dose for greater than or equal to 4 weeks and must not be expected to stop the medication during the study period): antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy (herbal teas from a grocery store are allowed), warfarin (1 mg of daily warfarin is allowed for central line patency)
- History of allergic or other adverse reaction to flaxseed, wheat, nuts, lactose, and/or certain spices
- Current or planned use of other agents for treating hot flashes (except stable dose of vitamine E or antidepressants are allowed as long as they wre started >30 days prior to study initiation and are to be continued through the study period).
- Diabetes (as flaxseed can lower blood glucose levels and might have additive effects when used with antidiabetic drugs).
- Diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture.
- Any of the following: pregnant women, nursing women, women of childbearing potential who are unwilling to employ adequate contraception
- Current use of anticoagulants including aspirin, clopidogrel (Plavix), ticlopidine (Ticlic), and coumadin (1 mg of dialy coumadin is allowed for central line patency).
- Diagnosis of/problems with von Willebrand's disease or other bleeding disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Evaluation of Flaxseed for the Treatment of Hot Flashes
Flaxseed, a phytoestrogen, is a natural food supplement rich in plant ligands, which have a very weak estrogen effect. In this study, flaxseed is being evaluated in regard to its capacity to safely and effectively treat hot flashes. Specifically, this study seeks to determine if flaxseed will lower the number and severity of hot flashes and if women experience any side effects from taking flaxseed for this purpose.
- Conditions
- Hot Flashes
- Being tested
- Flaxseed
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlaxseedDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if flaxseed will lower the number and severity of hot flashes
Determine if there are any side effects from taking flaxseed for hot flashes
Evaluate the impact of flaxseed on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
Evaluate the toxicity of flaxseed in this study population.
Evaluate the effect of flaxseed on quality-of-life measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startMay 2005
- Primary completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Investigators
- Sandhya Pruthi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275704
- Sponsor's protocol ID
- MC04C9
- Other IDs
- MC04C9, 247-05
- Status last verified
- Jun 2011
- First submitted
- 10 Jan 2006
- Last updated
- 10 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Flaxseed for the Treatment of Hot Flashes
- ClinicalTrials.gov ID
- NCT00275704
- Acronym / sponsor ID
- MC04C9
- Conditions
- Hot Flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- May 2005
- Primary completion
- Jun 2006 (actual)
- First posted
- 12 Jan 2006 (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.
Flaxseed, a phytoestrogen, is a natural food supplement rich in plant ligands, which have a very weak estrogen effect. In this study, flaxseed is being evaluated in regard to its capacity to safely and effectively treat hot flashes. Specifically, this study seeks to determine if flaxseed will lower the number and severity of hot flashes and if women experience any side effects from taking flaxseed for this purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Flaxseed | Drug | – |
Primary outcome
Determine if flaxseed will lower the number and severity of hot flashes
Determine if there are any side effects from taking flaxseed for hot flashes
Evaluate the impact of flaxseed on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
Evaluate the toxicity of flaxseed in this study population.
Evaluate the effect of flaxseed on quality-of-life measures.
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 10 Jun 2011.
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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.
Sandhya Pruthi, M.D. principal investigator
Mayo Clinic
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 Flaxseed in people with Hot Flashes, run by Mayo Clinic 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?
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 10 Jun 2011. 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. 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?
Determine if flaxseed will lower the number and severity of hot flashes. The study lists 5 primary outcomes in all. 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 10 Jun 2011.