Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial.

BACKGROUND: We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. METHODS: open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18-75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. RESULTS: the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). CONCLUSIONS: there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials, RBR-23w5fv . Registered 10 January 2017 - Retrospectively registered.

Factors associated with changes in vaginal length and diameter during pelvic radiotherapy for cervical cancer.

OBJECTIVES: This study reports the incidence and factors associated with vaginal stenosis and changes in vaginal dimensions after pelvic radiotherapy for cervical cancer. METHODS: A descriptive longitudinal study with 139 women with cervical cancer was conducted from January 2013 to November 2015. The outcome variables were vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE v3.0) and changes in vaginal diameter and length after the end of radiotherapy. Independent variables were the characteristics of the neoplasm, clinical and sociodemographic data. Bivariate analysis was carried out using χ 2, Kruskal-Wallis and Mann-Whitney's test. Multiple analysis was carried out using Poisson regression and a generalized linear model. RESULTS: Most women (50.4%) had stage IIIB tumors. According to CTCAE v3.0 scale, 30.2% had no stenosis, 69.1% had grade 1 and 0.7% had grade 2 stenosis after radiotherapy. Regarding changes in vaginal measures, the mean variation in diameter was - 0.6 (± 1.7) mm and the mean variation in length was - 0.6 (± 1.3) cm. In the final statistical model, having tumoral invasion of the vaginal walls (coefficient + 0.73, p < 0.01) and diabetes (coefficient + 1.16; p < 0.01) were associated with lower vaginal stenosis and lower reduction of vaginal dimensions. Advanced clinical stage (coefficient + 1.44; p = 0.02) and receiving brachytherapy/teletherapy (coefficient - 1.17, p < 0.01) were associated with higher reduction of vaginal dimensions. CONCLUSIONS: Most women had mild vaginal stenosis with slight reductions in both diameter and length of the vaginal canal. Women with tumoral invasion of the vagina have an increase in vaginal length soon after radiotherapy due to a reduction in tumoral volume.

Sexual function and quality of life in women with cervical cancer before radiotherapy: a pilot study.

PURPOSE: To achieve a better understanding of issues related to sexual function and quality of life (QOL) of women with cervical cancer before radiotherapy treatment. METHODS: A pilot study with 80 women with cervical cancer from Jan/2013 to Mar/2014. The outcome variables were sexual function assessed using the Female Sexual Function Index (FSFI) and QOL, assessed using the World Health Organization questionnaire. Independent variables were clinical and sociodemographic data. Statistical analysis was carried out using Student's t test, Mann-Whitney test, ANOVA and multiple linear regression. RESULTS: The mean age was 48.1 years, 57.5 % were premenopausal and 55 % had clinical stage IIIB. Thirty percent had been sexually active in the 3 months prior to their interviews. The main adverse events during sexual intercourse were bleeding (41.7 %), lack of pleasure (33.3 %), dyspareunia (25 %), and vaginal dryness (16.7 %). The 18 women who had been sexually active in the previous month showed significant sexual dysfunction (total mean FSFI score = 25.6). Advanced clinical stage, using any chronic medication and not having undergone surgery for cancer were negatively correlated with QOL. Higher family income, a longer duration of schooling and no smoking were positive correlated with QOL. CONCLUSIONS: One-third of women with cervical cancer were sexually active 3 months prior to their interviews, but have concomitant significant sexual dysfunction. Factors related to the disease are primarily responsible for the deterioration of sexual function. QOL is influenced not only by factors related to the cancer itself, but also by lifestyle habits, comorbidities, and sociodemographic characteristics.

Quality of life and adverse events after radiotherapy in gynecologic cancer survivors: a cohort study.

PURPOSE: To evaluate quality of life (QOL) in gynecologic cancer survivors after radiotherapy (RT), investigate the frequency of adverse events and demonstrate an association between these symptoms and QOL. METHODS: A prospective cohort study of 95 women aged 21-75 years undergoing RT for gynecologic cancer was carried out. QOL was assessed by the WHOQOL-BREF before, at 4 months, 1 year and 3 years after RT and adverse events were evaluated following RT by the (CTCAE) v 3.0 scale. QOL scores were assessed by the Wilcoxon signed rank test over time. Multiple linear regression analysis was used to identify predictors of QOL. RESULTS: The most frequent adverse events were pain (64.2%) and dyspareunia (45.9%). A significant increase in QOL scores was observed in the psychological domain, general health and overall QOL. Pain was negatively associated with the physical, psychological and social relationship domains (p < 0.01); dyspareunia with the physical and social relationship (p < 0.01); decreased sexual interest with the psychological (p < 0.01). Higher family income was positively associated with the psychological domain and general health (p < 0.01). CONCLUSIONS: Results suggested that QOL improved after RT in women with gynecologic cancer. Adverse events, such as pain, dyspareunia and decreased sexual interest had a negative impact on QOL.

Quality of life and acute toxicity of radiotherapy in women with gynecologic cancer: a prospective longitudinal study.

OBJECTIVE: To investigate the incidence of acute toxicity of radiotherapy, evaluate quality of life (QOL) and identify its predictors in a cohort of gynecologic cancer patients. METHODS: A longitudinal prospective study was conducted including 107 women between the ages of 18 and 75 years with cervical or endometrial cancer. Acute toxicity was evaluated according to the Common Toxicity Criteria and the Radiotherapy Oncology Group toxicity criteria. QOL was measured with World Health Organization's Quality of Life instrument-abbreviated version (WHOQOL-BREF) before and at completion of radiotherapy and during the first clinical follow-up visit. QOL scores were assessed by ANOVA for repeat measures. Percentage variation of QOL scores from the time before radiotherapy to the first clinical visit was compared with control variables by the Wilcoxon test. Multiple linear regression analysis was used to identify predictors of QOL. RESULTS: Ninety-five women completed the three QOL assessments. The incidence of acute toxicity was 93.5% and the most common complaint was lower gastrointestinal (79.6%). A significant increase in QOL scores was observed in the physical and psychological domains, as well as general health and overall QOL. Upper gastrointestinal toxicity (p = 0.043) and surgery (p = 0.027) negatively affected general health, while improvement in vaginal bleeding (p = 0.047) positively influenced general health. CONCLUSION: A high incidence of acute toxicity of radiotherapy was observed. At the completion of treatment, QOL improved in gynecologic cancer patients. Women with upper gastrointestinal toxicity and history of surgery are at risk for having a worse QOL.

Quality of life of women with gynecologic cancer: associated factors.

OBJECTIVE: To evaluate quality of life (QOL) and identify its associated factors in a cohort of women with gynecologic cancer. METHODS: A cross-sectional study was conducted, including 103 women with cervical or endometrial cancer, aged between 18 and 75 years who were receiving their entire treatment at the institution where the investigation was carried out. QOL was measured by the World Health Organization's QOL instrument-abbreviated version (WHOQOL-BREF). Clinical and sociodemographic characteristics, in addition to prevalence of cancer-related symptoms prior to radiotherapy were investigated. Bivariate analysis was performed, applying the Mann-Whitney test. Multivariate analysis was used to identify factors associated with QOL. RESULTS: The mean age of the participants was 56.8 +/- 11.6 years. The study included 67 (65%) women with cervical cancer and 36 (35%) women with endometrial cancer. Most participants were at an advanced stage (63.1%). The most common complaints were pain (49.5%) and vaginal bleeding (36.9%). The prevalence of anemia was 22.3%. On multivariate analysis, it was observed that anemia (P = 0.006) and nausea and/or vomiting (P = 0.010) determined impairment in physical domain. Pain negatively influenced physical domain (P = 0.001), overall QOL (P = 0.024), and general health (P = 0.013), while the history of surgery positively affected general health (P = 0.001). CONCLUSION: Cancer-related symptoms were factors that most interfered with QOL in women with gynecologic cancer. Therefore, more attention should be focused on identifying these symptoms, adopting measures to minimize their repercussions on QOL.

Implementacão do processo de enfermagem em uma unidade de radioterapia: elaboracão de instrumento para registro / Implementation of nursing process in a radiotherapy unit: creation of a record card

É meta de nosso servico sistematizar a assistência de enfermagem a clientes portadoras de câncer genital e mamário, submetidas a tratamento ambulatorial em radioterapia, através do processo de enfermagem, utilizando-se, na fase diagnóstica, a taxionomia da North American Nursing Diagnosis Association (NANDA) e os problemas colaborativos. Foram elaboradas fichas que permitissem o registro de forma sucinta e completa dos dados mais relevantes para a assistência de enfermagem, contendo: anamnese, orientacões gerais a respeito do tratamento, principais diagnósticos de enfermagem e problemas colaborativos, intervencões, resultados esperados e evolucão. Esses impressos foram testados no servico e avaliados pela equipe que os desenvolveu quanto ao conteúdo e diagramacão, até se obterem os modelos atuais que são apresentados neste artigo

[Implementation of the nursing process in a radiotherapy unit: development of a medical record]. / Implementação do processo de enfermagem em uma unidade de radioterapia: elaboração de instrumento para registro.

The goal of our service is to systematize the nursing care provided to the clients with gynecological and mammary cancer who underwent radiation therapy, using the nursing process, the North American Nursing Diagnosis Association (NANDA) taxonomy and collaborative problems in the diagnoses phase. Therefore, we created a record card in which we briefly reported the relevant data to nursing care, containing: anamnesis, general explanations about treatment, main collaborative problems, nursing diagnoses, interventions, outcomes and evolution. This card was tested in service and evaluated by the group that had created it regarding content and design, enabling the elaboration of its last version that is presented in the article.