Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma

October 24, 2016 updated by: Sandra Tuyaerts, University Hospital, Gasthuisberg
This therapy aims to determine whether curcumin can inhibit tumor induced inflammation in patients with endometrial carcinoma. In addition, curcumin could possibly induce a better functioning of chemotherapy and a decrease in toxicity from chemotherapy. Various studies have demonstrated that curcumin can have an effect on tumor growth and the development of metastases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Various cancer types are associated with chronic inflammation. During the formation of cancer the immune system is being activated by the tumor in order to evoke an anti-tumor immune response. However, as the tumor develops, this gives rise to a chronic inflammation, causing the immune system to malfunction. This is being highlighted by the fact that different chronic inflammatory diseases are associated with an increased risk of cancer (f.i. chronic inflammatory bowel diseases and colon cancer, prostatitis and prostate cancer, hepatitis and liver cancer). Endometrial cancer reveals different aspects of inflammation, including cytokine secretion and the infiltration of immune cells in this type of tumors. It is presumed that hormonal fluctuations and genetic changes contribute to the formation of a pro-inflammatory environment that stimulates tumor growth. Cancer cells of endometrial tumors do not only produce immunomodulatory mediators, but also attract different sorts of cells of the immune system that stimulate tumor growth.

It has already been demonstrated in mice models and in vitro experiments that curcumin shows strong anti-inflammatory effects that can slow down tumor growth and/or prevent formation of metastases. In addition, it has been noticed in these models that curcumin also has a positive effect on the functioning of various chemotherapeutic drugs, causing their effect to enhance or their toxicity to decrease.

Clinical studies investigating the anti-inflammatory effect of curcumin are rare, but these studies do reveal a suppression of the inflammation. The primary reason why clinical studies with curcumin are rare is because of the bad intake of curcumin in the human body. Recently, there has been a lot of research carried out regarding the development of new formulations of curcumin that lead to a better intake in the human body. The best nutritional supplement containing curcumin that has been developed so far is Meriva®, which is commercialized in Belgium under the name "CurcuPhyt".

Study Type

Interventional

Enrollment (Actual)

7

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

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital KU Leuven Campus Gasthuisberg

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:

  • Endometrial carcinoma at time of recurrence
  • No life-threatening metastases

Exclusion Criteria:

  • Other active malignancy
  • Documented autoimmune disease
  • Currently ongoing immunosuppressive therapy
  • Simultaneous treatment according to other clinical trials
  • Documented immune deficiency

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Curcuphyt
Intake of Curcuphyt capsules, 2 g per day during 2 weeks
Dietary supplement: Curcuphyt
Other Names:
  • Meriva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in inflammatory markers in peripheral blood from baseline
Time Frame: baseline, day 1, day 7, day 14, day 21
baseline, day 1, day 7, day 14, day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: up to 3 weeks
up to 3 weeks
Change from Baseline in Quality of Life score
Time Frame: baseline, day 14
baseline, day 14

Collaborators and Investigators

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

Sponsor

University Hospital, Gasthuisberg

Collaborators

Reliable Cancer Therapies

Investigators

  • Principal Investigator: Frederic Amant, MD, PhD, UZ Leuven

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

October 1, 2013

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (ESTIMATE)

December 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S55201
  • 2013-001737-40 (EUDRACT_NUMBER)

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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