Endometrial cancer Melatonin Endometrial cancer Ki-67 Proliferative marker Randomized double blind placebo-control trial
Conditions
Interventions
Participants receive oral melatonin 4 mg nightly for 14 days before surgery. Stop 2 days before surgery. Standard care is continued. Adherence is assessed by pill count.,Participants receive matched o
Experimental Drug,Placebo Comparator Drug
Sponsors
Hospital research Fund, rajavithi hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants have a histopathological diagnosis of endometrial cancer, specifically endometrioid adenocarcinoma, confirmed by endometrial biopsy. 2. Participants are scheduled to undergo surgical staging at Rajavithi Hospital. 3. Participants have a minimum interval of at least 2 weeks between study enrollment and the planned date of surgery. 4. Participants have an available baseline tissue specimen for assessment of the tumor proliferative marker Ki-67 prior to surgery, and provide consent for collection of postoperative tissue for repeat Ki-67 assessment. 5. Participants are older than 18 years of age. 6. Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7. Participants are of Thai nationality and are able to communicate in Thai with adequate comprehension. 8. Participants provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Participants with a history of hypersensitivity or allergy to melatonin or any excipients, including lactose and calcium. 2. Participants with a history of liver or kidney disease, or abnormal hepatic or renal function, defined as AST or ALT greater than 2 to 3 times the upper limit of normal, and or estimated glomerular filtration rate less than 60 mL per minute per 1.73 m2. 3. Participants with autoimmune disease, specifically systemic lupus erythematosus. 4. Participants with a history of depression. 5. Participants with a history of epilepsy or seizure disorder. 6. Participants who have used immunosuppressive drugs. 7. Participants who have used melatonin within 2 weeks prior to study enrollment. 8. Participants who are pregnant or breastfeeding. 9. Participants who consume alcohol. 10. Participants who smoke tobacco. 11. Participants currently using medications that may interact with melatonin metabolism or effects, including quinolone antibiotics such as ciprofloxacin, antiepileptic drugs such as carbamazepine, sedative hypnotics including benzodiazepines and non benzodiazepines, anti tuberculosis therapy including rifampicin, antidepressants including fluvoxamine, histamine H2 receptor antagonists including cimetidine, or hormone replacement therapy including estrogens and progestogens. 12. Participants who have received systemic anticancer therapy prior to study enrollment, such as progestins, tamoxifen, or chemotherapy. 13. Participants who refuse surgical treatment. 14. Participants who do not consent to repeat endometrial sampling if the initial biopsy specimen is insufficient for immunohistochemical staining to assess tumor proliferative activity. 15. Participants whose histopathological diagnosis is a non endometrioid histologic subtype, meaning pathology other than endometrioid adenocarcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ki-67 proliferation index Baseline (pre-treatment endometrial biopsy) and Day 14 (surgical specimen at staging surgery, after 14-day intervention). Ki-67 IHC on tumor tissue; % positive tumor nuclei (labeling index). Compare baseline biopsy vs surgical specimen after 14 days, and melatonin vs placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic findings and FIGO stage At staging surgery (Day 14, post-intervention) Final surgical pathology and FIGO stage determined from surgical staging specimen; compare distribution of stage and pathologic characteristics between groups.,Serum CA125 Baseline and Day 14 (preoperative, after 14-day intervention). Serum CA125 level measured by standard laboratory assay; evaluate change from baseline to post-intervention and compare between groups.,Serum HE4 Baseline and Day 14 (preoperative, after 14-day intervention) Serum HE4 level measured by standard laboratory assay; evaluate change from baseline to post-intervention and compare between groups.,Adverse events AEs assessed by structured phone calls on Days 3, 7, and 14 after starting study drug; safety labs on Day 14; repeat AE call 2 to 4 weeks after completing study medication. Adverse events assessed by structured symptom review and graded using CTCAE version 5.0; compare frequency and severity between groups. | — |
Countries
Thailand
Contacts
Public ContactPutsarat Insin
Rajavithi hospital
Outcome results
None listed