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
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Carcinoma||Dietary Supplement: Curcuphyt||Phase 2|
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)|
|Official Title:||Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||October 2016|
Intake of Curcuphyt capsules, 2 g per day during 2 weeks
Dietary Supplement: Curcuphyt
Other Name: Meriva
- Change in inflammatory markers in peripheral blood from baseline [ Time Frame: baseline, day 1, day 7, day 14, day 21 ]
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: up to 3 weeks ]
- Change from Baseline in Quality of Life score [ Time Frame: baseline, day 14 ]
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|
|Principal Investigator:||Frederic Amant, MD, PhD||UZ Leuven|