Cervical Cancer
Conditions
Interventions
Within 30 days after the end of radiotherapy treatment for cervical cancer, 60 eligible patients will be randomized 1:1 using random allocation software 2.0 program (30 patients in each group) and sub
D06.472.334.851.437
Sponsors
Instituto de Medicina Integral Professor Fernando Figueira
Instituto de Medicina Integral Professor Fernando Figueira
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Women aged between 18 and 55 years; Histological diagnosis of cervical carcinoma stages I to IIIc2; Radiotherapy treatment including external beam radiotherapy with a total dose used between 45 and 50.4Gy and brachytherapy with a total dose used between 24 and 28Gy; No personal history of neoplasia, except non-melanoma skin
Exclusion criteria
Exclusion criteria: Women with comorbidities that contraindicate the use of vaginal estrogen; Patients undergoing surgical treatment for cervical cancer; Persistent disease on gynecological examination after the thirtieth day after the end of radiotherapy treatment; Histological diagnosis of small cell cervical cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome to be assessed is the degree of histological maturation, with vaginal epithelium with maturation grades 1 to 3 being considered atrophic and 4 and 5 being considered trophic (Grade 1: absence of epithelium in the sample; Grade 2: incomplete basal cell layer; Grade 3: epithelial coverage with basal and parabasal cells; inadequate maturation in stratum spinosum; Grade 4: maturation in stratum spinosum; Grade 5: maturation in stratified squamous epithelium). A greater number of samples of mature vaginal epithelium (grades 4 and 5) are expected to be found in the group that used vaginal estrogen, based on the finding of a variation of at least 5% between the groups in the post-intervention assessments. If the data follow a normal distribution, we will use the paired t-test to compare the scores before and after the intervention in each group and the Student's t-test to compare the differences between the groups. If the data does not follow a normal distribution, we will use the Wilcoxon test for paired samples and the Mann-Whitney test for independent samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, sexual function and pain during the follow-up gynecological examination will be assessed as secondary outcomes using specific questionnaires as well as the EORTC QLQ-C30, EORTC QLQ-CX24 and FSFI questionnaires. Improvements in quality of life, sexual function and decreased pain during the gynecological examination are expected in the group that used vaginal estrogen compared to the group that used placebo, based on the observation of a variation of at least 5% in the post-intervention assessments between the groups. If the data follow a normal distribution, we will use the paired t-test to compare the scores before and after the intervention in each group and the Student's t-test to compare the differences between the groups. If the data do not follow a normal distribution, we will use the Wilcoxon test for paired samples and the Mann-Whitney test for independent samples. | — |
Countries
Brazil
Contacts
Public ContactNathalia Ramalho
Instituto de Medicina Integral Professor Fernando Figueira
Outcome results
None listed