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

Endometrial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017353
• Other study ID #: S55201
• Secondary ID: 2013-001737-40
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2013
• Last updated: October 24, 2016
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma
• Endometrial Neoplasms
• Inflammation

Intervention

Dietary Supplement:
• Curcuphyt

Locations

Country	Name	City	State
Belgium	University Hospital KU Leuven Campus Gasthuisberg	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg	Reliable Cancer Therapies

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inflammatory markers in peripheral blood from baseline		baseline, day 1, day 7, day 14, day 21	No
Secondary	Number of Participants with Serious and Non-Serious Adverse Events		up to 3 weeks	Yes
Secondary	Change from Baseline in Quality of Life score		baseline, day 14	No