Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission
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|ClinicalTrials.gov Identifier: NCT02324439|
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer||Drug: Omega Nutrition cold-milled flaxseeds||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2022|
Experimental: Omega Nutrition cold-milled flaxseeds
All subjects will receive a 20g daily dose of cold-milled flaxseeds for 24 months.
Drug: Omega Nutrition 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.
Other Name: cold-milled flaxseeds
- 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.
- Progression free survival (PFS) [ Time Frame: change from baseline values over 24 months ]Analysis of CA-125, review of symptoms and imaging (if indicated)
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): NCT02324439
|Contact: Laurent Brard, MD, PhDfirstname.lastname@example.org|
|Contact: Kathleen A Groesch, MSemail@example.com|
|United States, Illinois|
|Southern Illinois University School of Medicine||Recruiting|
|Springfield, Illinois, United States, 62702|
|Contact: Kathleen A Groesch, M.S., CCRP 217-545-6671 firstname.lastname@example.org|
|Contact: Laurent Brard, M.D., PhD 217-545-8000 email@example.com|
|Principal Investigator:||Laurent Brard, MD, PhD||Southern Illinois University School of Medicine|