Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma
Primary Purpose
Endometrial Carcinoma
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Curcuphyt
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Carcinoma
Eligibility Criteria
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
Sites / Locations
- University Hospital KU Leuven Campus Gasthuisberg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Curcuphyt
Arm Description
Intake of Curcuphyt capsules, 2 g per day during 2 weeks
Outcomes
Primary Outcome Measures
Change in inflammatory markers in peripheral blood from baseline
Secondary Outcome Measures
Number of Participants with Serious and Non-Serious Adverse Events
Change from Baseline in Quality of Life score
Full Information
NCT ID
NCT02017353
First Posted
December 16, 2013
Last Updated
October 24, 2016
Sponsor
University Hospital, Gasthuisberg
Collaborators
Reliable Cancer Therapies
1. Study Identification
Unique Protocol Identification Number
NCT02017353
Brief Title
Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma
Official Title
Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gasthuisberg
Collaborators
Reliable Cancer Therapies
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curcuphyt
Arm Type
Experimental
Arm Description
Intake of Curcuphyt capsules, 2 g per day during 2 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcuphyt
Other Intervention Name(s)
Meriva
Primary Outcome Measure Information:
Title
Change in inflammatory markers in peripheral blood from baseline
Time Frame
baseline, day 1, day 7, day 14, day 21
Secondary Outcome Measure Information:
Title
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame
up to 3 weeks
Title
Change from Baseline in Quality of Life score
Time Frame
baseline, day 14
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Amant, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital KU Leuven Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma
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