Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission

NCT02324439 | Completed Phase 1

• 1 other identifier: Brard-SIUSOM-2014-004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

ovarian cancer; flaxseed; dietary supplement; organic dietary supplement; recurrence

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (1)

• Progression free survival (PFS)

  change from baseline values over 24 months

Study Arms (1)

Omega Nutrition cold-milled flaxseeds

EXPERIMENTAL

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

Drug: Omega Nutrition cold-milled flaxseeds

Interventions

Omega Nutrition cold-milled flaxseeds DRUG

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.

Also known as: cold-milled flaxseeds

Omega Nutrition cold-milled flaxseeds

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Ovarian Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent Brard, MD, PhD

  Southern Illinois University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 24, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

US (1)