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Effect of curcumin addition to standard treatment on inflammation in endometrial carcinoma

Phase 1
Active, not recruiting
Conditions
endometrial carcinoma
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2013-001737-40-BE
Lead Sponsor
Z Leuven
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Recruiting
Sex
Female
Target Recruitment
0
Inclusion Criteria

Endometrial carcinoma, histologically confirmed
No life-threatening metastases

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Evaluation of inflammatory markers in blood at regular time points<br>Toxicity;Secondary Objective: Time to development of new metastases<br>Response rate<br>;Primary end point(s): Effect on inflammatory mediators in blood;Timepoint(s) of evaluation of this end point: day 0, day 1, day 7, day 14, day 21
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): Clinical response;Timepoint(s) of evaluation of this end point: baseline and after standard of care treatment
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