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Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omega Nutrition cold-milled flaxseeds
Sponsored by
Southern Illinois University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epithelial Ovarian Cancer focused on measuring ovarian cancer, flaxseed, dietary supplement, organic dietary supplement, recurrence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Sites / Locations

  • Southern Illinois University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega Nutrition cold-milled flaxseeds

Arm Description

All subjects will receive a 20g daily dose of cold-milled flaxseeds for 24 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression free survival (PFS)
Analysis of CA-125, review of symptoms and imaging (if indicated)

Full Information

First Posted
November 21, 2014
Last Updated
March 30, 2022
Sponsor
Southern Illinois University
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1. Study Identification

Unique Protocol Identification Number
NCT02324439
Brief Title
Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission
Official Title
Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Illinois University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Keywords
ovarian cancer, flaxseed, dietary supplement, organic dietary supplement, recurrence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega Nutrition cold-milled flaxseeds
Arm Type
Experimental
Arm Description
All subjects will receive a 20g daily dose of cold-milled flaxseeds for 24 months.
Intervention Type
Drug
Intervention Name(s)
Omega Nutrition cold-milled flaxseeds
Other Intervention Name(s)
cold-milled flaxseeds
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of consuming 20g of flaxseed per day
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
Analysis of CA-125, review of symptoms and imaging (if indicated)
Time Frame
change from baseline values over 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Brard, MD, PhD
Organizational Affiliation
Southern Illinois University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States

12. IPD Sharing Statement

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Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission

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