Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Wounds and Injuries

Rare Diseases

Uterine Cervical Neoplasms

Vaginal Neoplasms

Fractures, Bone

Hip Fractures

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vaginal Diseases

Femoral Fractures

Hip Injuries

Leg Injuries

Vaginal Cancer

Bone Mineral Density Test + MRI or CT + Blood Test

During routine visits, a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.

Blood (about 1 tablespoon) will be drawn to test for bone turnover.

CT or MRI + Blood Test

Kathleen Schmeler, MD

The goal of this study is to estimate how often pelvic fractures occur in women treated with radiation therapy for either newly diagnosed or recurrent cervical, endometrial, or vaginal cancer. The study will also estimate the changes in bone mineral density and the changes in the blood that relate to "bone turnover". High bone turnover can weaken bones and make you more likely to break a bone.

If you agree to take part in this study, the following tests and procedures will be performed before radiation therapy:

* You will have a bone mineral density test. A bone mineral density test measures bone loss over time, identifies osteoporosis (a disease of the bones that causes them to be weak and easily breakable) or the risk for developing osteoporosis, and checks your risk for fractures. During the test, you will lie on a cushioned table while a mechanical arm-like device will pass over your body. This device will not touch you.
* During your routine visits, you may have either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan of the pelvis as part of your standard of care. A PET scan may be done if your doctor thinks it is necessary. These scans will be reviewed by the research staff of this study to determine your response to therapy, determine if your cancer has returned, and to look for broken bones.
* Blood (about 1 tablespoon) will be drawn to test for bone turnover.
* Blood (about 2 to 3 teaspoons) will be drawn for tests to measure the level of vitamin D, calcium, phosphorus, and parathyroid hormone (PTH).
* Researchers will collect information from your medical record. This information will include your medical history, your ethnicity, if you have had any bone fractures, if you have a history of bone fractures in your family, and your use of tobacco and/or alcohol.

At 4 weeks after start of radiation therapy, blood (about 2 to 3 teaspoons) will be drawn to test for bone turnover.

At 3 months, 1 year, and 2 years after you complete radiation:

* You will have a bone mineral density test.
* You may have either an MRI or CT scan of the pelvis as part of your standard of care. A PET scan may be done if your doctor thinks it is necessary. These scans will be reviewed by the research staff of this study to determine your response to therapy, determine if your cancer has returned, and to look for broken bones.
* Blood (about 2 tablespoons) will be drawn for tests to measure the level of vitamin D and to test for bone turnover.

Length of Study:

You will be off study 2 years after you complete radiation.

After 2 years and for up to 5 years, results of bone density tests or scans of the pelvis that you have outside of this study will be collected.

This is an investigational study.

Up to 300 women will take part in the study. All will be enrolled at MD Anderson.

Pelvic Fractures and Radiation Therapy for Cervical Cancer

Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Participants will use an app to submit photos of their surgical site, QoR15 scores, and EORTC selected adverse events scores daily for 2 weeks post-op \& weekly for another 4 weeks. Surgeons will use a wireless interface to access that data and monitor the patient's condition. Participants will complete questionnaires and keep diaries related to satisfaction, medical system encounters, surgical complications, followup-related financial costs, and telemedicine satisfaction at 2 \& 6 weeks post-op. They will attend prescribed follow-up appointments with their surgeon with the option to skip 1 or more follow-up appointments dependent on their recovery trajectory \& surgeon.

The conventional follow-up care group will keep to conventional follow-up schedules of all surgeons involved. They will complete questionnaires and keep diaries related to satisfaction, medical system encounters, surgical complications, and followup-related financial costs at 2 \& 6 weeks post-op and attend all scheduled follow up appointments.

The mobile app follow-up care is an application that can be loaded onto a smartphone. It allows the patient to submit photos of their surgical site, QoR15 scores, and EORTC selected adverse events scores. The information collected is transmitted to members of the surgical team (i.e. the primary surgeon) and used to monitor recovery over the first 6 weeks following surgery.

RecoverWell mobile app for follow-up care

Claire Temple-Oberle, MD MSc FRCSC

This study will assess whether the implementation of a combination of ERAS (Enhanced Recovery After Surgery) protocols and postoperative followup via a smartphone app can offer 1) improved patient satisfaction, 2) virtual patient monitoring without an increase in postoperative emergency room visits, number and severity of postoperative complications, and readmissions, 3) decreased healthcare system costs, and 4) improved patient convenience and reduced patient financial costs. The study will be conducted among women having mastectomy, breast reconstruction, and gynecological oncology procedures. Half of the participants will be assigned to physician monitoring via a smartphone app and half will receive conventional care.

ERAS® (Enhanced Recovery After Surgery) protocols are evidence-based best practices bundled together to revolutionize pre-, intra-, and postoperative care resulting in better patient outcomes, increased patient postoperative satisfaction, and decreased healthcare costs. ERAS® protocols in breast reconstruction and gynecologic oncology have been developed by surgeons from the Tom Baker Cancer Centre and have the sanction of the international ERAS® Society for implementation globally.

As of 2015, the majority of Canadians owned a cell phone. Technological advances in these forms of communications have been shown to positively impact patient experience and reduce healthcare system burdens. Telemedicine delivered healthcare via smartphone apps now include platforms for encouraging healthy behaviors, monitoring chronic healthcare conditions, organizing personal healthcare records, and monitoring postsurgical wounds.

The proposed study would marry these two advances, ERAS® protocols and smartphone technology, to consider how the combination of these two approaches to postsurgical care might enhance patient satisfaction and convenience and minimize financial burden while providing high quality care and monitoring. Additionally, the combination of these approaches has the potential to benefit the healthcare system in a number of ways. By lessening surgery-related length of stay and reducing the number of postsurgical visits, an opportunity for cost-savings is evident. In addition, in a system that is troubled by long wait-times for some procedures, reducing lengths of stay and surgeons' postoperative clinical burden means more patients can be seen and treated in a timely fashion. This is a win-win for the healthcare system and patients. It provides structure for more efficiently caring for post-operative patients in a patient first manner that supports physicians, transforms care, and engages in responsible stewardship of healthcare resources according to the Foundational Strategies developed by Alberta Health Services.

The current study would assess the patient, physician, and healthcare system impact of combining ERAS® protocol-guided oncological surgery with postsurgical patient monitoring via a smartphone app that would lessen patients' postoperative burden when postoperative recovery is uneventful and would alert physicians earlier when things are not going well.

Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery

The PSQ-III is a validated questionnaire made up of several subscales and employing a "statement of opinion" response model of 5 response categories (strongly agree, agree, uncertain, disagree, strongly disagree). The subscales being employed in the current study include general satisfaction, communication with your doctor, time spent with doctor, financial aspects, and access/availability/convenience.

The Quality of Recovery 15 scale captures patient reported postoperative assessment of various dimensions of health including patient support, comfort, emotions, physical independence, and pain. Patients rate each of the 15 statements from 1 (never) to 10 (always).

The costs related to attending one or more surgical followup appointments will be tracked. Participants will maintain a log of all associated expenses.

The total number of contacts with the healthcare system postoperatively will be tracked.

All complications occurring within the study period will be tracked. This information will be gathered.

Select adverse events including diarrhea, constipation, fever, urinary frequency/urgency, vaginal bleeding, wound complications, and fatigue will be tracked.

The participating surgeons and study nurses will keep diaries of time spent on patient followup, including followup appointments, receiving and returning phone calls, and tame spent related to virtual monitoring via the smartphone app.

A telephone interview will be conducted with study surgeons and nursing staff at the end of the study to inquire into the impact on medical professionals conducting conventional versus virtual monitoring of postoperative patients.

Alberta Cancer Foundation

Alberta Health Services, Calgary

Professor, Departments of Surgery and Oncology

Urinary Retention

Urination Disorders

Urologic Diseases

Male Urogenital Diseases

removal of urinary catheter postoperatively

removal of urinary catheter less than 24 hours after surgery

Early removal of urinary catheter postoperatively

removal of urinary catheter greater than 24 hours after surgery

Late removal of urinary catheter postoperatively

This is a combined retrospective observational study that will collect data on urinary catheter removal of patients who underwent pelvic surgery by a gynecologic oncologist to assess timing safety and its implications in postoperative care.

Optimal Management of Urinary Catheter in Gyn Onc

Optimal Management and Timing of Removal of Urinary Catheter Following Pelvic Surgery by the Gynecologic Oncology Surgeon

urinary retention rate will be measured as need for re-catheterization postoperatively

WellSpan Health

Site Director, Gynecology Oncology

Symptoms and General Pathology

Substance Related Disorders

Frailty

Drug-Related Side Effects and Adverse Reactions

Delayed Emergence from Anesthesia

Postoperative Complications

Chemically-Induced Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Neuromuscular Blocking Agents

Patient receive TOF nerve stimulation in recovery room after surgery

Patient receive nerve stimulation by TOF-scan equipment at recovery room after surgery.

Train of four nerve stimulator

Patchareya Nivatpumin, M.D.

Jitsupa Nithiuthai, M.D.

Nutthavit Hantayapong, M.D.

Frailty among patients undergoing surgery is strongly associated with an elevated risk of adverse perioperative outcomes, heightened incidence of postoperative complications, increased mortality rates, and prolonged hospital length of stay. Our focus centers on investigating the frailty index in the context of complications experienced by patients undergoing oncologic gynecology surgery. The principal objective of this research is to elucidate the extent to which residual neuromuscular blocking agents are linked to frailty.

Among patients undergoing oncologic gynecological procedures, such as those for vulvar cancer, endometrial cancer, and ovarian cancer, the incidence of frailty has been observed to range from 14% to 45%. Frailty directly influences the metabolism of anesthetic agents and intraoperative management. Furthermore, the prevalence of residual neuromuscular blocking agents following surgery can be as high as 26% to 53%. No prior research has investigated the correlation between residual muscle relaxants and frailty in gynecologic oncology patients. This study is designed to assess the prevalence of residual muscle relaxants in these patients with frailty. Additionally, data on the incidence of frailty and its impact on postoperative outcomes and prognosis in patients undergoing gynecologic oncology surgery will be collected and reported.

Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

Incidence of Residual Neuromuscular Blockade in Patients With Frailty Undergoing Gynecologic Cancer Surgery

Incidence of residual neuromuscular blockade with the relation of frailty after gynecologic oncology surgery

Incidence of frailty in patients undergoing gynecologic oncology surgery

Anesthetic technique used in patients undergoing gynecologic oncology surgery

Rate of vasopressor usage eg. ephedrine, norepinephrine

Number of patients who require intensive care unit admission after surgery

Number of patients who require re-intubation

Number of patients who require mechanical ventilation postoperative

Number of patients who have postoperative pulmonary complications eg. prolonged intubation, atelectasis, pneumonia etc.

Number of patients who died after surgery

Mahidol University

Gland and Hormone Related Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.

Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.

Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.

John Micha, MD

Since the mortality rates for patients with advanced ovarian carinoma are high, the most likely way to improve progression free and overall survival is with maximal "upfront" therapy (Morrow \& Curtin, 1998). Currently, no triplet regimen has demonstrated compelling superiority. Therefore, the combination of Paclitaxel, Carboplatin, and Vorinostat is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.

Ovarian cancer is the fifth most common cancer in women, accounting for nearly 15,280 deaths annually in the United States \[1\]. Paclitaxel and Carboplatin are currently the accepted standard of care for first line treatment of ovarian cancer \[2, 3\]. In spite of standard chemotherapy, nearly 70% of patients succumb to this disease. Consequently, studies continue to examine the activity of new agents and dosing regimens to improve disease free intervals and overall survival.

There have been recent data suggesting that weekly chemotherapy regimens may significantly benefit cancer patients' prognosis \[4, 5\]. Non-small cell lung cancer patient studies employing weekly regimens have shown comparable response and survival rates to Q3 weekly dosing schedules, with a more favorable toxicity profile \[6, 7\]. Further studies have suggested that weekly Taxane dosing is at least as effective, less toxic, and more convenient than traditional regimens \[4, 8, 9\].

The favorable activity associated with weekly chemotherapy has primarily been studied in recurrent ovarian cancer patients, investigating the efficacy of single and/or combination drug regimens \[10, 11\]. However, there have been some studies involving chemo-naïve patients \[4, 12, 13\]. De Jongh et al. \[4} conducted a randomized I/II ovarian cancer trial with cisplatin and escalating doses of weekly or 4-weekly paclitaxel. The chemo-naïve patients exhibited a 94% overall response rate and 48 month median overall survival, while maintaining manageable toxicity. In a more recent advanced ovarian cancer study, Isonishi et al. compared the impact of paclitaxel and carboplatin administered either tri-weekly (c-TC) or dose dense weekly (dd-TC) with regard to patient progression free survival (PFS) \[14\]. Median PFS for the c-TC patients was 17.1 months and 27.9 months for the dd-TC group. There was also more favorable survival rates in the dose dense patients (83.6%) in comparison to the tri-weekly groups (77.7%)

Shen et al. conducted a Chinese study investigating the efficacy of combination weekly Taxol plus Carboplatin compared to Taxol given every three weeks plus Carboplatin in previously untreated ovarian cancer patients \[12\]. While the two regimens had equal efficacy, there was less toxicity observed in the weekly regimen. Additional studies have also indicated that lower doses and shorter infusion times inherent in weekly dosing regimens should mitigate bone marrow myelosuppression and other toxicities associated with standard paclitaxel 3-weekly administration \[13\].

In addition to weekly primary induction chemotherapy regimens, studies involving consolidation or maintenance therapy have been employed in the hopes of improving survival \[15, 16\]. Micha et al. reported significantly better progression free survival results (94 weeks vs. 45 weeks) for an ovarian cancer group who received 12 cycles of paclitaxel consolidation therapy following induction therapy, compared to a similar group who received 3 cycles of paclitaxel consolidation therapy \[16\].

The current pilot study was designed to determine toxicity, progression free survival, and response rate of weekly Taxol; every four-week Carboplatin; and Vorinostat (7 days on, 7 days off 7 days on, 7 days off) given for 6 cycles. Some patients will continue on consolidation therapy, which will consist of Taxol in combination with Vorinostat for an additional 12 cycles.

Modifying the dosing schedule of established chemotherapy regimens using weekly chemotherapy administration and consolidation therapy may decrease drug toxicity and maximize efficacy. These benefits are particularly intriguing in patients for whom disease treatment is long-term.

Since no triplet regimen has demonstrated compelling superiority, the combination of Taxol, Carboplatin, and Vorinostat is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.

Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma

A Phase I/II, Open-Label, Non-Randomized, Pilot Study of Weekly Paclitaxel, Every Four-week Carboplatin and Oral Vorinostat for Patients Newly Diagnosed With Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Clinical response was assessed by clinical, serologic, and radiographic means.

Progression-free survival was defined as the length of time from the date of initial induction chemotherapy until clinical, radiological, or CA-125 progression

Merck Sharp & Dohme LLC

Gynecologic Oncology Associates

All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.

Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.

Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

John P. Micha, M.D.

Response Evaluation Criteria In Solid Tumors (RECIST v1.0)

Objective Response Rate

Number of Participants With Progression Free Survival (PFS) up to 24 Months

Overall Study

Nervous System Diseases

Pain, Postoperative

Pain

Neurologic Manifestations

Vasoconstrictor Agents

Respiratory System Agents

Bupivacaine

Epinephrine

Anesthetics, Local

Racepinephrine

Epinephryl borate

TAP block with bupivicaine/epinephrine placed prior to surgery.

TAP block with placebo placed prior to surgery

The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis

Bupivicaine

The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.

Placebo

David M Kushner, MD

This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial

Pain scores by the Visual Analog Scale (VAS) \[0-5, where 0 is no pain and 5 is extreme\] and Wisconsin Brief Pain Inventory (BPI) \[where 0 is no pain and 10 is the most painful\], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score.

University of Wisconsin, Madison

TAP block with bupivicaine/epinephrine placed prior to surgery.

Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis

TAP block with placebo placed prior to surgery

Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.

Total

Race (NIH/OMB)

Body Mass Index (BMI)

The treatment group, who received TAP block placement, was younger than the saline injection group, on average (55.2 versus 62.1, P = 0.028).

Unilateral placement of block may decrease overall effectiveness. Sample size was small, from single institution, and encompassed a variety of diagnoses and procedures. Analysis also included intraoperative medications.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pelvic Fractures and Radiation Therapy for Cervical Cancer	NCT00800644	Cervical Cancer Endometrial Can... Vaginal Cancer	CT or MRI + Blo...	-	M.D. Anderson Cancer Center
Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery	NCT03456167	Breast Cancer Gynecologic Can...	RecoverWell mob...	18 Years -	Alberta Health Services, Calgary
Optimal Management of Urinary Catheter in Gyn Onc	NCT05538273	Urinary Retenti...	Early removal o... Late removal of...	18 Years -	WellSpan Health
Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery	NCT06216002	Frailty Neuromuscular B... General Anesthe... Gynecologic Can... Surgical Compli...	Train of four n...	18 Years -	Mahidol University
Pelvic Fractures and Radiation Therapy for Cervical Cancer	NCT00800644	Cervical Cancer Endometrial Can... Vaginal Cancer	CT or MRI + Blo...	-	M.D. Anderson Cancer Center
Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma	NCT00976183	Ovarian Neoplas...	Vorinostat Vorinostat	18 Years -	Gynecologic Oncology Associates
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery	NCT01444924	Gynecologic Can... Post-operative ...	Bupivicaine Placebo	18 Years -	University of Wisconsin, Madison
Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery	NCT03456167	Breast Cancer Gynecologic Can...	RecoverWell mob...	18 Years -	Alberta Health Services, Calgary

Spots Global Cancer Trial Database for gynecologic oncology