Epithelial Ovarian CancerPhase 1NCT02324439
Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission
A Phase 1 study testing Omega Nutrition cold-milled flaxseeds in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Southern Illinois University at 1 site in United States.
Trial summary
This is a phase 0/phase I feasibility trial to test the hypothesis that flaxseed supplementation is an effective maintenance therapy for patients with ovarian cancer who are in clinical remission following platinum-based regimens. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- Omega Nutrition cold-milled flaxseeds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2021
- Phase
- Phase 1
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of OC including epithelial ovarian carcinoma, primary peritoneal cancer or fallopian tube cancer who are currently in clinical remission as determined by the PI or co-I and are within 4 months of completion of cancer treatment.
- Patients at risk of clinical relapse: patients of any stage who are in remission who have undergone surgical debulking and adjuvant chemotherapy.
- Patients must have adequate:
- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Toxicity Criteria (CTCAE v4.0) Grade 1. Platelets greater than or equal to 100,000/mcl (CTCAE v4.0 Grade 0-1). Hemoglobin (Hgb) greater than or equal to 9.0g/dl (CTCAE v4.0 Grade 2).
- Renal function: Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 Grade 1.
- Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v4.0 Grade 1). Serum glutamate oxaloacetate transaminase (SGOT) and alkaline phosphatase ≤ 2.5 x ULN (CTCAE v4.0 Grade 1).
- Women of childbearing potential must have a negative pregnancy test.
Who cannot join
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- Patients with ovarian cancer of low malignant potential (borderline cancers).
- Patients who have received prior radiotherapy or chemotherapy for another malignancy.
- Patients who are pregnant or lactating.
- Patients with serious medical or psychiatric illness.
- Patients with a history of inflammatory bowel disease, problems with chronic diarrhea or history of bowel obstruction.
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- Patient has received other investigational drugs within 28 days before enrollment.
- Patients with concurrent uncontrolled illness.
- Patients unable to tolerate and/or allergies to flaxseed or flaxseed preparations.
- Patients with Gynecologic Oncology Group (GOG) performance status > 2.
- Patients with a history of uncontrolled diabetes (as flaxseed can lower blood glucose levels and might have additive effects when used with anti-diabetic drugs).
- Patients concurrently using anticoagulants/antiplatelets on a DAILY BASIS, including aspirin, Clopidogrel (Plavix), Ticlopidine (Ticlid), and Coumadin.
- Patients with a diagnosis of/problems with von Willebrand's disease or other bleeding disorders (as flaxseed may slow blood clotting; the risk of bruising or bleeding in people on anticoagulants or with bleeding disorders may be a concern).
- Flaxseed supplementation may be contraindicated in patients with acute abdomen, esophageal stricture or perforation, dysphagia, GI obstruction or ileus, acute intestinal inflammation or unexplained abdominal pain. Patients with any of these conditions will be excluded from this trial as the high fiber content of flaxseed may make these conditions worse
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
About this study
This is a phase 0/phase I feasibility trial to test the hypothesis that flaxseed supplementation is an effective maintenance therapy for patients with ovarian cancer who are in clinical remission following platinum-based regimens. The investigators further hypothesize levels of estrogen metabolites and prostaglandin E2 in this patient population will correlate with recurrence of disease, extent of tumor burden, invasion and metastasis.
Read the detailed description
For the year 2014, it is projected there will be 21,980 women diagnosed and 14,270 deaths from ovarian cancer (OC) in the US. OC is the leading cause of death from gynecologic malignancies and ranks second among newly diagnosed gynecological cancers in the United States. More than 70% of patients present with advanced disease (stages II-IV). Although most patients (70-80%) initially respond to cytoreductive surgery and adjuvant paclitaxel and platinum-based chemotherapy, approximately 80% of these women will experience disease recurrence. For stages III and IV, the risk of recurrence is very high, with 5-year survival rates ranging from just 13% to 44%. Furthermore, OC represents a high potential for metastases even in the setting of complete response to initial therapy. Efforts to devise new treatment strategies are therefore essential in order to improve survival. In this grant application, the investigators postulate that utilizing dietary supplementation of flaxseed for maintenance therapy in patients with OC in clinical remission following treatment with platinum-based regimens will be tolerable and prolong their progression-free survival (PFS). The investigators hypothesis is based on the following:
- Data from the investigators laboratory revealed that flaxseed effectively decreased severity and progression of OC in the only spontaneous preclinical egg-laying hen model that fully recapitulates human OC.
- In a phase II study, flaxseed supplementation reduced proliferation rates of prostate cancer after just 30 days.
- Flaxseed has been shown to inhibit solid tumor growth and metastases in several other preclinical cancer models (breast, prostate, colon).
- Flaxseed is a safe dietary supplement for cancer patients.
- Flaxseed supplementation increased survival in our investigators' animal model and these flaxseed-fed hens exhibited lower inflammatory markers and maintained a healthy weight, inferring a better quality of life (QOL).
- Being tested
- Omega Nutrition cold-milled flaxseeds
- Keywords
- ovarian cancer, flaxseed, dietary supplement, organic dietary supplement, recurrence
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega Nutrition cold-milled flaxseedsDrug
Also called cold-milled flaxseeds
Patients who are currently in clinical remission will receive a daily 20g dose of cold milled flaxseed as a dietary supplement to determine if this intervention prolongs clinical remission.
| Study group | Role | What they receive |
|---|---|---|
| Omega Nutrition cold-milled flaxseeds | Experimental | All subjects will receive a 20g daily dose of cold-milled flaxseeds for 24 months. Receives: Drug: Omega Nutrition cold-milled flaxseeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of consuming 20g of flaxseed per day
To determine the feasibility of administering a 20 gram (g) per day dose of ground flaxseed to patients with histology-proven epithelial ovarian cancer who have undergone surgical debulking and adjuvant chemotherapy with platinum-based regimens and are currently in clinical remission.
Measured: 24 months
Secondary outcomes (1)
Progression free survival (PFS)
Analysis of CA-125, review of symptoms and imaging (if indicated)
Measured: change from baseline values over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionMar 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Brard, MD, PhD, Principal investigator, Southern Illinois University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324439
- Sponsor's protocol ID
- Brard-SIUSOM-2014-004
- Status last verified
- Mar 2022
- First submitted
- 21 Nov 2014
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission
- ClinicalTrials.gov ID
- NCT02324439
- Acronym / sponsor ID
- Brard-SIUSOM-2014-004
- Keywords
- ovarian cancer, flaxseed, dietary supplement, organic dietary supplement, recurrence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 24 Dec 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 is a phase 0/phase I feasibility trial to test the hypothesis that flaxseed supplementation is an effective maintenance therapy for patients with ovarian cancer who are in clinical remission following platinum-based regimens. The investigators further hypothesize levels of estrogen metabolites and prostaglandin E2 in this patient population will correlate with recurrence of disease, extent of tumor burden, invasion and metastasis.
Detailed description
For the year 2014, it is projected there will be 21,980 women diagnosed and 14,270 deaths from ovarian cancer (OC) in the US. OC is the leading cause of death from gynecologic malignancies and ranks second among newly diagnosed gynecological cancers in the United States. More than 70% of patients present with advanced disease (stages II-IV). Although most patients (70-80%) initially respond to cytoreductive surgery and adjuvant paclitaxel and platinum-based chemotherapy, approximately 80% of these women will experience disease recurrence. For stages III and IV, the risk of recurrence is very high, with 5-year survival rates ranging from just 13% to 44%. Furthermore, OC represents a high potential for metastases even in the setting of complete response to initial therapy. Efforts to devise new treatment strategies are therefore essential in order to improve survival. In this grant application, the investigators postulate that utilizing dietary supplementation of flaxseed for maintenance therapy in patients with OC in clinical remission following treatment with platinum-based regimens will be tolerable and prolong their progression-free survival (PFS). The investigators hypothesis is based on the following:
- Data from the investigators laboratory revealed that flaxseed effectively decreased severity and progression of OC in the only spontaneous preclinical egg-laying hen model that fully recapitulates human OC.
- In a phase II study, flaxseed supplementation reduced proliferation rates of prostate cancer after just 30 days.
- Flaxseed has been shown to inhibit solid tumor growth and metastases in several other preclinical cancer models (breast, prostate, colon).
- Flaxseed is a safe dietary supplement for cancer patients.
- Flaxseed supplementation increased survival in our investigators' animal model and these flaxseed-fed hens exhibited lower inflammatory markers and maintained a healthy weight, inferring a better quality of life (QOL).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega Nutrition cold-milled flaxseeds | Experimental | Drug: Omega Nutrition cold-milled flaxseedsAll subjects will receive a 20g daily dose of cold-milled flaxseeds for 24 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with a diagnosis of OC including epithelial ovarian carcinoma, primary peritoneal cancer or fallopian tube cancer who are currently in clinical remission as determined by the PI or co-I and are within 4 months of completion of cancer treatment.
- Patients at risk of clinical relapse: patients of any stage who are in remission who have undergone surgical debulking and adjuvant chemotherapy.
- Patients must have adequate:
- Women of childbearing potential must have a negative pregnancy test.
Key exclusion criteria (14 listed)
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- Patients with ovarian cancer of low malignant potential (borderline cancers).
- Patients who have received prior radiotherapy or chemotherapy for another malignancy.
- Patients who are pregnant or lactating.
- Patients with serious medical or psychiatric illness.
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 Nutrition cold-milled flaxseedsAlso: cold-milled flaxseedsPatients who are currently in clinical remission will receive a daily 20g dose of cold milled flaxseed as a dietary supplement to determine if this intervention prolongs clinical remission. | Drug | Omega Nutrition cold-milled flaxseeds |
Primary outcome
Feasibility of consuming 20g of flaxseed per day
Time frame: 24 months
To determine the feasibility of administering a 20 gram (g) per day dose of ground flaxseed to patients with histology-proven epithelial ovarian cancer who have undergone surgical debulking and adjuvant chemotherapy with platinum-based regimens and are currently in clinical remission.
1 secondary outcome
Progression free survival (PFS)
Time frame: change from baseline values over 24 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 1 Apr 2022.
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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.
Laurent Brard, MD, PhD principal investigator
Southern Illinois University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega Nutrition cold-milled flaxseeds in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Southern Illinois University 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 7 inclusion and 14 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 1 Apr 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Feasibility of consuming 20g of flaxseed per day (time frame: 24 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 1 Apr 2022.