Endometrial CarcinomaPhase 2NCT02017353
Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma
A Phase 2 study testing Curcuphyt in people with Endometrial Carcinoma, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Carcinoma
- What is being tested?
- Curcuphyt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endometrial carcinoma at time of recurrence
- No life-threatening metastases
Who cannot join
- Other active malignancy
- Documented autoimmune disease
- Currently ongoing immunosuppressive therapy
- Simultaneous treatment according to other clinical trials
- Documented immune deficiency
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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".
- Conditions
- Endometrial Carcinoma
- Being tested
- Curcuphyt
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuphytDietary supplement
Also called Meriva
| Study group | Role | What they receive |
|---|---|---|
| Curcuphyt | Experimental | Intake of Curcuphyt capsules, 2 g per day during 2 weeks Receives: Dietary Supplement: Curcuphyt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory markers in peripheral blood from baseline
Measured: baseline, day 1, day 7, day 14, day 21
Secondary outcomes (2)
Number of Participants with Serious and Non-Serious Adverse Events
Measured: up to 3 weeks
Change from Baseline in Quality of Life score
Measured: baseline, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Collaborators
- Reliable Cancer Therapies
- Responsible party
- Principal investigator, Sandra Tuyaerts, University Hospital, Gasthuisberg
- Investigators
- Frederic Amant, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017353
- Sponsor's protocol ID
- S55201
- Other IDs
- 2013-001737-40
- Status last verified
- Oct 2016
- First submitted
- 16 Dec 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT02017353
- Acronym / sponsor ID
- S55201
- Conditions
- Endometrial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- Reliable Cancer Therapies
- Study start
- Oct 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curcuphyt | Experimental | Dietary Supplement: CurcuphytIntake of Curcuphyt capsules, 2 g per day during 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Endometrial carcinoma at time of recurrence
- No life-threatening metastases
Key exclusion criteria (5 listed)
- Other active malignancy
- Documented autoimmune disease
- Currently ongoing immunosuppressive therapy
- Simultaneous treatment according to other clinical trials
- Documented immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuphytAlso: Meriva | Dietary supplement | Curcuphyt |
Primary outcome
Change in inflammatory markers in peripheral blood from baseline
Time frame: baseline, day 1, day 7, day 14, day 21
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic Amant, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcuphyt in people with Endometrial Carcinoma, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammatory markers in peripheral blood from baseline (time frame: baseline, day 1, day 7, day 14, day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.