NCT02324439

Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Southern Illinois University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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. 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).

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2020-03-01
• Completion: 2021-03-01
• First posted: 2014-12-24
• Last updated: 2022-04-01

Locations

1 site across 1 country: United States