Trial record 6 of 50 for:    ovarian cancer recurrence | Open Studies | Exclude Unknown

Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Southern Illinois University
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University
ClinicalTrials.gov Identifier:
NCT02324439
First received: November 21, 2014
Last updated: November 3, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Drug: Omega Nutrition cold-milled flaxseeds
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission

Resource links provided by NLM:


Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: change from baseline to 3 months ] [ Designated as safety issue: No ]
    Analysis of Cancer Antigen 125 (CA-125), review of symptoms and imaging (if indicated)


Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: change from baseline to 6 months ] [ Designated as safety issue: No ]
    Analysis of CA-125, review of symptoms and imaging (if indicated)

  • Progression free survival (PFS) [ Time Frame: change from baseline to 9 months ] [ Designated as safety issue: No ]
    Analysis of CA-125, review of symptoms and imaging (if indicated)

  • Progression free survival (PFS) [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
    Analysis of CA-125, review of symptoms and imaging (if indicated)

  • Progression free survival (PFS) [ Time Frame: change from baseline to 24 months ] [ Designated as safety issue: No ]
    Analysis of CA-125, review of symptoms and imaging (if indicated)


Estimated Enrollment: 90
Study Start Date: March 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02324439

Contacts
Contact: Laurent Brard, MD, PhD 217-545-8882 lbrard@siumed.edu
Contact: Kathleen A Groesch, MS 217-545-6671 kgroesch@siumed.edu

Locations
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    kgroesch@siumed.edu   
Contact: Laurent Brard, M.D., PhD    217-545-8000    lbrard@siumed.edu   
Sponsors and Collaborators
Southern Illinois University
Investigators
Principal Investigator: Laurent Brard, MD, PhD Southern Illinois University School of Medicine
  More Information

Responsible Party: Southern Illinois University
ClinicalTrials.gov Identifier: NCT02324439     History of Changes
Other Study ID Numbers: Brard-SIUSOM-2014-004 
Study First Received: November 21, 2014
Last Updated: November 3, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Southern Illinois University:
ovarian cancer
flaxseed
dietary supplement
organic dietary supplement
recurrence

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on July 21, 2016