A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors
This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein requirements based on the individual's body weight. The PSMF may help endometrial cancer survivors achieve significant weight loss, reduce the risk of chronic disease, and improve quality of life.
NCT02135562 — Obesity
Status: Completed
http://inclinicaltrials.com/obesity/NCT02135562/
A Single Arm Phase II Trial of BMN 673 for Inoperable, Advanced Endometrial Cancer With Retrospective PTEN, MSI and MRE11 Analysis
A Single Arm Phase II Trial of BMN 673 for Inoperable, Advanced Endometrial Cancer With Retrospective PTEN, MSI and MRE11 Analysis PTEN= Phosphatase and tensin homolog MSI= Microsatellite instability MRE11= Double-strand break repair protein MRE11A This trial will investigate whether the drug BMN 673 has therapeutic benefit in the treatment of advanced endometrial cancer. Nearly 8,000 patients are diagnosed with endometrial cancer in the UK every year. A significant proportion are either diagnosed with advanced disease which may be inoperable and/or metastatic (i.e spread to other organs outside the endometrium), or curable disease which relapses following first line treatment. There is no established standard of care for these patients as both chemo and hormone therapy has limited effectiveness and survival benefit. Survival rates have not improved in the past 20 years. Furthermore there are no so called 'targeted' drugs licensed for its treatment i.e. drugs that block the growth and spread of cancer by interfering with specific molecules involved in tumor growth and progression. This leaves an unmet need for effective systemic treatments for advanced, inoperable and metastatic endometrial cancer. BMN 673 has been shown to be potentially effective in treating cancers known to behave similarly to endometrial disease, both in the laboratory and in Phase I studies involving patients with advanced cancers. Similarly the drug appears to be relatively tolerable. A Phase II trial such as the one proposed by this application could demonstrate activity that might lead to a new effective treatment for patients with inoperable, advanced, recurrent or metastatic endometrial cancer, while the proposed substudy also presents the possibility of discovering a subset of patients more likely to derive benefit from BMN 673. This trial is for adult women (18 and above) with advanced, inoperable or metastatic endometrial cancer. Patients will be recruited from approximately 15 National Health Service (NHS) Trusts based in the United Kingdom (UK). The study is expected to last approximately 18-24 months in terms of recruitment time, and a maximum of 100 eligible women will be registered. All patients will receive BMN 673 until their disease worsens or their doctor decides they should stop treatment.
NCT02127151 — Endometrial Cancer
Status: Withdrawn
http://inclinicaltrials.com/endometrial-cancer/NCT02127151/
Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.
The purposes of this study are - to determine the prevalence, size and impact on quality of life of lymphedema of the lower extremities after primary radical surgery with hysterectomy +/- pelvic - and paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO (International Federation of Gynecology and Obstetrics) stage 1 and 2 - to analyze risk factors for development of lymphedema in this specific group of patients. Our hypotheses are that women who have lymphadenectomy more often suffer from lymphedema, subjectively and objectively, and have an impaired quality of life. This is a Swedish multicenter study carried out in 17 departments of Obstetrics and Gynecology and in 3 departments of Oncology. All participants are treated according to the Swedish National Guidelines for Endometrial Cancer. 130 women with endometrial cancer who have a hysterectomy with lymphadenectomy (high-risk endometrial carcinomas) and 130 women with endometrial cancer who have a hysterectomy without lymphadenectomy (low-risk endometrial carcinomas) are prospectively enrolled in the study. The participants are examined preoperatively and on 3 occasions postoperatively, i.e. 4-6 weeks , 6 months and 12 months postoperatively. Determination of occurrence of lymphedema of the lower extremities are determined objectively by 1) a standardized clinical evaluation according to Bruna et al.[1] and 2) determining the leg volume according to the cone model by Sitzia [2] by systematically measuring of leg circumferences. In addition, occurrence of lymphedema is measured subjectively by the participants. On the same four occasions as the leg circumference measurements are conducted the patients complete two generic health related quality of life forms (the EuroQol EQ-5D and the Short-Form 36 SF-36) and the condition specific quality of life form for limb lymphedema (LYMQOL). Demographic and clinical data are systematically collected until one year postoperatively including occurrence of complications and given adjuvant oncological therapy such as chemo- and radiation therapy. On each occasion of clinical control a vaginal ultrasound examination is carried out in order to register pelvic and abdominal lymphocele formation or lymphatic fluid effusion intraabdominally.
NCT02115477 — Hysterectomy
Status: Completed
http://inclinicaltrials.com/hysterectomy/NCT02115477/
A Clinical Trial to Evaluate Endometrial Cancer Biomarker Changes Following Exposure to the Insulin Sensitizer Metformin
The investigators will explore the chemopreventive role of metformin. The purpose of this study is to determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue. This is a phase IIa study of metformin to be used to the pre-operative period of women diagnosed with endometrial cancer by comparing their endometrial biopsy specimens taken at their initial visit and after 4-6 weeks of treatment of metformin on the day of their surgical staging.
NCT02042495 — Endometrial Cancer
Status: Withdrawn
http://inclinicaltrials.com/endometrial-cancer/NCT02042495/
A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.
NCT01979003 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT01979003/
Sentinel Lymph Node Mapping for Endometrial Cancer
This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.
NCT01939028 — Stage III Endometrial Carcinoma
Status: Terminated
http://inclinicaltrials.com/stage-iii-endometrial-carcinoma/NCT01939028/
A Randomized Phase I Study With a Safety Lead-In to Assess the Antitumor Efficacy of the MEK Inhibitor Trametinib Alone or in Combination With GSK2141795, an AKT Inhibitor, in Patients With Recurrent or Persistent Endometrial Cancer NCT #01935973
This randomized phase I trial studies how well trametinib with or without GSK 2141795 (protein kinase B [Akt] inhibitor GSK2141795) works in treating patients with endometrial cancer that has come back (recurrent) or does not go to remission despite treatment (persistent). Trametinib and Akt inhibitor GSK2141795 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is a more effective treatment for endometrial cancer when given with or without ATK inhibitor GSK2141795.
NCT01935973 — Endometrial Adenocarcinoma
Status: Completed
http://inclinicaltrials.com/endometrial-adenocarcinoma/NCT01935973/
A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer
This phase II trial studies how well cabozantinib s-malate works in treating patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
NCT01935934 — Endometrial Serous Adenocarcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-serous-adenocarcinoma/NCT01935934/
A Pilot Study of Postoperative Lower-extremity Lymphedema and Quality of Life Among Women Undergoing Endometrial Cancer Staging Surgery
Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo staging surgery. Data analysis and risk/safety issues: The proposed study will consist of a convenience sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period. The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference with its 95% exact confidence intervals between pre-and post-operative lower extremity lymphedema measurements and quality of life questionnaires will be estimated.
NCT01914276 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT01914276/
Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer
The overall goal of this proposal is to investigate the potential benefit of metformin as a novel therapy for the treatment of endometrial cancer. Investigators will evaluate the effect of short-term metformin treatment on the endometrium of obese women with endometrial cancer by comparing each patient's endometrial biopsy before treatment with metformin to their post-treatment hysterectomy specimen. Participants: Obese women who are to undergo surgical staging for endometrial cancer will also receive short-term treatment (1-4 weeks) with metformin that will continue until the day prior to surgical staging. The effect of metformin on proliferation, apoptosis and downstream signaling pathways will be compared between pre-treatment endometrial biopsies and post-treatment hysterectomy specimens. Tissue microarrays will be constructed and immunohistochemstry performed to evaluate proliferation, apoptosis and changes in critical signaling pathways mediated by metformin, and these findings will be correlated with our in vitro preclinical studies. Fresh tissue will also be obtained, and Western immunoblotting will be used to assess expression of the phosphorylated forms of the downstream targets of metformin. The hypothesis is that treatment with metformin will result in a decrease in proliferative markers and an increase in markers of apoptosis in the endometrial cancer tumors. AMPK phosphorylation and inhibition of critical downstream targets of the mTOR pathway will be seen in the post-treatment hysterectomy specimens. Metabolomic profiling will also be performed of tumors and associated biofluids (i.e. serum and urine) before and after treatment with metformin to identify potential biomarkers of response to this therapy.
NCT01911247 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT01911247/