Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer (Toco-Ovar)

November 26, 2020 updated by: Vejle Hospital
The purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, DK-7100
        • Department of Oncology, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
  • Prior treatment with at least two different cytostatic regimens including platinum.
  • Progression on previous treatment.
  • Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.
  • Age ≥ 18 years.
  • Performance stage 0-2.

  • Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

    • WBC ≥ 3.0 * 10^9/l or neutrophils (ANC) ≥ 1.5 * 109/l
    • Platelet count ≥ 100 * 10^9/l
    • Hemoglobin ≥ 6 mmol/l
    • Serum bilirubin < 2.0 * ULN
    • Serum transaminase ≤ 2.5 * ULN
    • Serum creatinine ≤ 1.5 ULN
  • Urine dipstick for protein <2+. If the dipstick shows protein ≥2+ 24 hour urine testing must be made with protein contents < 1 g.
  • Written informed consent.

Exclusion Criteria:

  • Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
  • Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
  • Underlying medical disease not adequately treated (diabetes, cardiac disease).
  • Uncontrolled hypertension (BT >150/100 despite antihypertensive treatment).
  • Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab.
  • Non-healing wounds or fractures.
  • Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment.

  • Clinically significant cardiovascular disease, including:

    • Myocardial infarction or unstable angina within 6 months before start of treatment
    • New York heart Association (NYHA) class ≥ 2
    • Poorly controlled cardiac arrhythmia despite medication
    • Periferal vascular disease grade ≥ 3
  • Allergy to the active substance or any of the auxiliary agents
  • Bleeding tumor
  • Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
  • Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab and Tocotrienol
Drug: Bevacizumab
10 mg/kg q3w
Drug: Tocotrinol
300 mg tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fraction of patients without progression after six months of treatment
Time Frame: 6 months after start of treatment
6 months after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Study Chair: Anders Jakobsen, DMSc, Department of Oncology, Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Toco-Ovar

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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