Treatment Trials

79 Clinical Trials for Various Conditions

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RECRUITING
Fucoidan for Preventing Chemotherapy-Related Fatigue in Patients with Gastrointestinal or Gynecological Cancer
Description

This clinical trial tests how well fucoidan works in preventing chemotherapy-related fatigue compared to a placebo in patients with gastrointestinal (GI) or gynecological (GYN) cancer. Fatigue poses a burden in patients with malignancies undergoing systemic chemotherapy. Fucoidan is a dietary supplement made of complex sugar that contain sulfate groups attached to their sugar units (sulfated polysaccharide) which found in brown seaweed. It is thought to have anti-inflammatory, anti-viral, anti-thrombotic, anti-diabetic, and anti-tumor effects in pre-clinical models. Giving fucoidan may be effective in preventing chemotherapy-related fatigue in patients with GI or GYN.

RECRUITING
Near Infrared Spectroscopy (NIRS) as a Method for Measuring Oxidative Capacity of Skeletal Muscle Mitochondria in Breast Cancer and All Gynecological Cancer Patients
Description

Participants recruited for this study will be breast cancer or gynecological cancer patients who agree to participate in an exercise study examining the effects of chemotherapy on muscle mitochondrial oxidative capacity, a measure of skeletal muscle health. Participants will ride a stationary bicycle and the quadriceps muscle will be non-invasively evaluated.

RECRUITING
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
Description

The phase II trial evaluates the effectiveness of cryocompression therapy alone or in combination with cilostazol in preventing paclitaxel-induced peripheral neuropathy (numbness, pain or tingling in the feet and hands) for patients with gynecologic cancers. Peripheral neuropathy is a common side effect of many chemotherapeutic agents, including paclitaxel. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Cryocompression is a therapy that combines compression garments or dressings with cooling of the treated area. Cilostazol is in a class of medications called platelet-aggregation inhibitors (antiplatelet medications). It works by improving blood flow to the legs. Giving cilostazol together with cryocompression may be safe and tolerable in treating patients with gynecological cancers.

RECRUITING
Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies
Description

The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies. Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point. Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.

ACTIVE_NOT_RECRUITING
Journey Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer
Description

This study looks at how well the Journey Ahead intervention works in improving coping and communication skills in participants with gynecologic cancers.

RECRUITING
Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy
Description

30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.

COMPLETED
Patient Perspective of Telemedicine in Gynecology Oncology
Description

Research question: do patients in a gynecologic oncology practice value the use of telemedicine as an adjunct to in-person visits and in what circumstances might patients not find these visits to be sufficient?

Conditions
TERMINATED
PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer
Description

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in Advanced Gynecological Malignancies with a Known ARID1A Mutation and PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer.

ACTIVE_NOT_RECRUITING
Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies
Description

This phase II trial studies the side effects and how well brachytherapy with durvalumab or tremelimumab work for the treatment of gynecological malignancies that is resistant to platinum therapy (platinum-resistant), does not respond to treatment (refractory), has come back (recurrent), or has spread to other places in body (metastatic). Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see whether brachytherapy with durvalumab or tremelimumab works better in treating patients with gynecological malignancies.

COMPLETED
Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies
Description

This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding the abdominal incision, and is effective in providing good relief of incisional pain. Hydromorphone is also a type of pain medication that may provide better management of deep abdominal pain. It is not yet known if giving liposomal bupivacaine with or without hydromorphone will work better in improving pain in patients with gynecological malignancies during the first 24 hours after surgery.

COMPLETED
Factors Influencing Cascade Testing Among Women With Hereditary Gynecological Cancers and Their Relatives
Description

This trial collects information about factors that affect communication of genetic test results, decision-making, and access to genetic testing in women with hereditary gynecological cancers. Studying individuals who are positive for a genetic mutation and immediate biological family members (including a parent, full-sibling, or child) may help identify cancer genes and other persons at risk.

WITHDRAWN
Improving Insulin Resistance in Gynecological Cancer Patients
Description

This is a research study to see if the addition of cinnamon to a provided food plan would improve insulin resistance in gynecological cancer patients. One study suggests that patients with gynecological cancers are more likely to be insulin resistant and/or have higher levels of fasting insulin. The study will be 24 weeks in length.

TERMINATED
The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
Description

This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting and Q-space Trajectory Imaging in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI.

WITHDRAWN
Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer
Description

This pilot clinical trial studies how well web-based coping and communication skills intervention works in improving psychological adaptation in patients with gynecological cancer. Web-based intervention, such as coping and communication skills intervention, may help doctors to get a better understanding of ways to help gynecological cancer patients cope with their cancer experience.

Conditions
Endometrial CarcinomaStage 0 Fallopian Tube Cancer AJCC v7Stage I Fallopian Tube Cancer AJCC v6 and v7Stage I Ovarian Cancer AJCC v6 and v7Stage IA Fallopian Tube Cancer AJCC v6 and v7Stage IA Ovarian Cancer AJCC v6 and v7Stage IB Fallopian Tube Cancer AJCC v6 and v7Stage IB Ovarian Cancer AJCC v6 and v7Stage IC Fallopian Tube Cancer AJCC v6 and v7Stage IC Ovarian Cancer AJCC v6 and v7Stage II Cervical Cancer AJCC v7Stage II Fallopian Tube Cancer AJCC v6 and v7Stage II Ovarian Cancer AJCC v6 and v7Stage II Uterine Corpus Cancer AJCC v7Stage IIA Cervical Cancer AJCC v7Stage IIA Fallopian Tube Cancer AJCC v6 and v7Stage IIA Ovarian Cancer AJCC V6 and v7Stage IIA1 Cervical Cancer AJCC v7Stage IIA2 Cervical Cancer AJCC v7Stage IIB Cervical Cancer AJCC v6 and v7Stage IIB Fallopian Tube Cancer AJCC v6 and v7Stage IIB Ovarian Cancer AJCC v6 and v7Stage IIC Fallopian Tube Cancer AJCC v6 and v7Stage IIC Ovarian Cancer AJCC v6 and v7Stage III Cervical Cancer AJCC v6 and v7Stage III Fallopian Tube Cancer AJCC v7Stage III Ovarian Cancer AJCC v6 and v7Stage III Primary Peritoneal Cancer AJCC v7Stage III Uterine Corpus Cancer AJCC v7Stage IIIA Cervical Cancer AJCC v6 and v7Stage IIIA Fallopian Tube Cancer AJCC v7Stage IIIA Ovarian Cancer AJCC v6 and v7Stage IIIA Primary Peritoneal Cancer AJCC v7Stage IIIA Uterine Corpus Cancer AJCC v7Stage IIIB Cervical Cancer AJCC v6 and v7Stage IIIB Fallopian Tube Cancer AJCC v7Stage IIIB Ovarian Cancer AJCC v6 and v7Stage IIIB Primary Peritoneal Cancer AJCC v7Stage IIIB Uterine Corpus Cancer AJCC v7Stage IIIC Fallopian Tube Cancer AJCC v7Stage IIIC Ovarian Cancer AJCC v6 and v7Stage IIIC Primary Peritoneal Cancer AJCC v7Stage IIIC Uterine Corpus Cancer AJCC v7Stage IIIC1 Uterine Corpus Cancer AJCC v7Stage IIIC2 Uterine Corpus Cancer AJCC v7Stage IV Cervical Cancer AJCC v6 and v7Stage IV Fallopian Tube Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v6 and v7Stage IV Primary Peritoneal Cancer AJCC v7Stage IV Uterine Corpus Cancer AJCC v7Stage IVA Cervical Cancer AJCC v6 and v7Stage IVA Uterine Corpus Cancer AJCC v7Stage IVB Cervical Cancer AJCC v6 and v7Stage IVB Uterine Corpus Cancer AJCC v7Uterine CarcinosarcomaUterine Corpus Sarcoma
UNKNOWN
The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
Description

This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.

COMPLETED
Psychological Services Integration in Gynecological Oncology Clinics
Description

The purpose of this study is to understand the feasibility and impact of integrated psychological care in outpatient gynecologic oncology clinics with the goal of creating a new standard of care. The investigators propose an intervention study comparing patient-centered outcomes (assessed by surveys) between women who receive usual care versus integrated psychological care. The investigators' objectives are to learn about the process of integration of psychological care directly into outpatient gynecologic oncology clinics and the impact of such integration on patients' well-being, presentation of symptoms, psychological functioning, coping mechanisms, awareness of support services offered, and perception of quality of care. As this is a feasibility study, aims are focused on assessing patient willingness for psychological intervention in the medical office, provider willingness to have psychologist present in clinic, and impact of psychological intervention. With such data to warrant further integration and time of psychologists in medical clinics, next steps for immediate and long-term projects may include focus on high risk populations, specific disease sites, additional provider clinics, more psychologist time spent in gynecological oncology clinics, and effectiveness of interventions with higher power. The investigators hope the results will serve as preliminary data for an integrated psychosocial care model that can be implemented in other oncology clinics.

COMPLETED
Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
Description

This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.

TERMINATED
PSMA PET and MRI in Gynecological Cancers
Description

The goal of this research is to determine the accuracy of PSMA positron emission tomography (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of gynecological cancer cells in the body.

COMPLETED
A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers
Description

The clinical trial was a companion study to protocol CL-PTL-119 (A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy (VITAL) NCT02346747). Participants who had investigational product (Vigil) successfully made but were not eligible to enroll onto the VITAL study or previously randomized to placebo were given the opportunity to participate in this protocol. The main goal of this clinical trial was to determine the safety of combining Vigil therapy with atezolizumab.

COMPLETED
Impact of a Systematic Social Work Driven Approach on Medical Power of Attorney Documentation, Knowledge, Attitudes, and Beliefs in Participants With Stage I-IV Gynecological Cancers
Description

This trial evaluates the impact of a systemic social work driven approach on medical power of attorney documentation, knowledge, attitudes, and beliefs in participants with stage I-IV gynecological cancers. Social work counseling and education may help increase the number of participants who complete medical power of attorney documents. Counseling and education may also affect attitudes about decision-making and willingness to take part in these conversations in participants with stage I-IV gynecological cancers and their family members and/or caregivers.

COMPLETED
Post-Operative Gynecological Oncology App Study
Description

Purpose: The purpose of this study will be to test the use of a web-based mobile application (app) initiated at the time of hospital discharge to engage and monitor patients in order to efficiently deliver better outcomes. The mobile app will be used to remind patients of discharge instructions, assess adherence treatment regimens, and evaluate symptoms. Rationale: Approximately 60% of patients with ovarian cancer have advanced stage disease at diagnosis, and thus aggressive surgical procedures are often medically necessary. Recent evidence suggests that nearly one in five patients hospitalized for ovarian cancer surgery will be readmitted within 30 days of discharge. Patients readmitted within 30 days have a 50% increase in one-year mortality rates and significantly increased costs of care. In addition, many of the conditions and complications that led to readmission could potentially have been avoided with more intensive post-surgical follow-up care. Mobile health technologies can effectively and efficiently connect patients with their healthcare team and have been shown to improve treatment adherence and reduce avoidable ER visits and hospitalizations.

COMPLETED
Enhanced Recovery After Surgery Gynecology Oncology
Description

The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing open abdominal surgery for gynecologic cancer or suspected gynecologic cancer. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay, without increasing readmission rates. ASD

TERMINATED
A Phase 1b Study of Paclitaxel And Ricolinostat For The Treatment Of Gynecological Cancer
Description

Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12 months of prior treatment that includes Platinum Chemotherapy are invited to take part in this study. This research study is studying a combination of a new chemotherapy drug called Ricolinostat together with the chemotherapy Paclitaxel and a drug called Bevacizumab as a possible treatment for this diagnosis.

COMPLETED
Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers
Description

This phase I trial studies the side effects and best dose of nab-paclitaxel and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery (unresectable), cancer of the cervix, endometrium, ovary, fallopian tube or peritoneal cavity. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop or slow tumor growth by blocking the growth of new blood vessels necessary for tumor growth. Giving nab paclitaxel and bevacizumab may kill more tumor cells than nab-paclitaxel alone.

Conditions
Cervical AdenocarcinomaCervical AdenosarcomaCervical Adenosquamous CarcinomaCervical CarcinosarcomaCervical Squamous Cell CarcinomaClinical Stage IV Cutaneous Melanoma AJCC v8Endometrial Adenosquamous CarcinomaEndometrial Clear Cell AdenocarcinomaEndometrial Endometrioid AdenocarcinomaEndometrial Mixed Cell AdenocarcinomaEndometrial Mucinous AdenocarcinomaEndometrial Serous AdenocarcinomaEndometrial Undifferentiated CarcinomaFallopian Tube AdenocarcinomaFallopian Tube CarcinosarcomaFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid AdenocarcinomaFallopian Tube Mucinous AdenocarcinomaFallopian Tube Serous AdenocarcinomaFallopian Tube Squamous Cell CarcinomaFallopian Tube Transitional Cell CarcinomaFallopian Tube Undifferentiated CarcinomaMalignant Female Reproductive System NeoplasmMalignant Ovarian Clear Cell TumorMalignant Ovarian Endometrioid TumorMalignant Ovarian Epithelial TumorMalignant Ovarian Mucinous TumorMalignant Peritoneal NeoplasmMalignant Solid NeoplasmOvarian CarcinosarcomaOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian High Grade Serous AdenocarcinomaOvarian Mucinous AdenocarcinomaOvarian Serous AdenocarcinomaOvarian Transitional Cell CarcinomaOvarian Undifferentiated CarcinomaPlatinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Ovarian CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaPlatinum-Sensitive Ovarian CarcinomaPrimary Peritoneal CarcinosarcomaPrimary Peritoneal Clear Cell AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaPrimary Peritoneal Transitional Cell CarcinomaPrimary Peritoneal Undifferentiated CarcinomaUnresectable MelanomaUterine Corpus Carcinosarcoma
COMPLETED
Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers
Description

The purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.

COMPLETED
Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Description

This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin may help provide nutrition to patients who are not able to eat or digest ordinary food. This may improve the quality of life of patients with gynecological cancer and help them recover more quickly from surgery.

COMPLETED
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
Description

The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive different amounts of carboplatin and gemcitabine.

TERMINATED
The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
Description

This pilot study will be a prospective, randomized trial which will take place at the University of Minnesota Medical Center (UMMC). Eligible patients will be identified at the time of their first clinic visit. If selected to be involved in the study, the patients will be randomized to one of three different groups: a Guided Imagery and Music therapy group (GIMT) or one of two control groups.

COMPLETED
AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
Description

The purpose of this research study is to determine the safety of the combination of the two drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given in combination to people safely. Cediranib is a drug that may stop blood supply to the tumor and therefore help keep cancer cells from growing. Temsirolimus is a drug that may stop cancer cells from growing. These drugs have been used in other research studies in ovarian and kidney cancer and these studies suggest that these drugs may help to keep cancer from growing in this research study.