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

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ClinicalTrials.gov Identifier: NCT02017353
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : October 25, 2016
Reliable Cancer Therapies
Information provided by (Responsible Party):
Sandra Tuyaerts, University Hospital, Gasthuisberg

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometrial Carcinoma Dietary Supplement: Curcuphyt Phase 2

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  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma
Study Start Date : October 2013
Primary Completion Date : May 2016
Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Curcuphyt
Intake of Curcuphyt capsules, 2 g per day during 2 weeks
Dietary Supplement: Curcuphyt
Other Name: Meriva

Primary Outcome Measures :
  1. Change in inflammatory markers in peripheral blood from baseline [ Time Frame: baseline, day 1, day 7, day 14, day 21 ]

Secondary Outcome Measures :
  1. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: up to 3 weeks ]
  2. Change from Baseline in Quality of Life score [ Time Frame: baseline, day 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017353

University Hospital KU Leuven Campus Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Reliable Cancer Therapies
Principal Investigator: Frederic Amant, MD, PhD UZ Leuven

Responsible Party: Sandra Tuyaerts, PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT02017353     History of Changes
Other Study ID Numbers: S55201
2013-001737-40 ( EudraCT Number )
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action