NCT02017353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

December 16, 2013

Last Update Submit

October 24, 2016

Conditions

Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Change in inflammatory markers in peripheral blood from baseline

    baseline, day 1, day 7, day 14, day 21

Secondary Outcomes (2)

  • Number of Participants with Serious and Non-Serious Adverse Events

    up to 3 weeks

  • Change from Baseline in Quality of Life score

    baseline, day 14

Study Arms (1)

Curcuphyt

EXPERIMENTAL

Intake of Curcuphyt capsules, 2 g per day during 2 weeks

Dietary Supplement: Curcuphyt

Interventions

CurcuphytDIETARY_SUPPLEMENT
Also known as: Meriva
Curcuphyt

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endometrial carcinoma at time of recurrence
  • No life-threatening metastases

You may not qualify if:

  • Other active malignancy
  • Documented autoimmune disease
  • Currently ongoing immunosuppressive therapy
  • Simultaneous treatment according to other clinical trials
  • Documented immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital KU Leuven Campus Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Frederic Amant, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 20, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

BE(1)