Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary Cancer and Changes...
Bladder CancerProstate Cancer1 moreThe objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.
Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular...
Metastatic Testicular CancerTesticular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.
A Biobehaviorial Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors...
Testicular CancerThis study is a randomized controlled biobehavioral efficacy trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients. Participants will be randomized to receive six sessions of GET or Individual Supportive Listening (ISL) delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1), twelve weeks after intervention (T2) and 24 weeks after the intervention (T3). Additionally, identified biomarkers will be measured at baseline and at T1, T2, and T3.
Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors
Germ Cell NeoplasmsTesticular Neoplasms7 moreThis is an open label, multi-institutional, single arm phase II trial of pembrolizumab in patients with incurable platinum refractory germ cell tumors. No randomization or blinding is involved.
Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors
Germ Cell TumorsTestis Cancer3 moreThis is a Phase II study to evaluate the activity of brentuximab vedotin in relapsed/refractory non-seminomatous germ cell tumors (NSGCT).
Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive...
Extragonadal Germ Cell TumorTesticular Germ Cell TumorRATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors. PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors.
Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage...
Ovarian DysgerminomaRecurrent Malignant Testicular Germ Cell Tumor6 moreImatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, refractory, or recurrent stage II or stage III testicular cancer or stage II or stage III ovarian cancer following cisplatin-based chemotherapy
Endocrine Disrupting Chemical Exposure and Testicular Cancer
Testicular CancerDISRUPT is a Danish nested case-control study that is currently being conducted to explore the impact of prenatal exposure to endocrine disrupting chemicals on testicular cancer risk (including histological sub-groups) with emphasis on the analysis of exposure mixtures. Pregnant mothers provided serum and amniotic fluid at recruitment up to 50 years ago. By registry linkage within highly reliable national population and disease registries cancer cases and matched controls will be identified. Levels of EDCs including DDT, DDE and other organochlorine pesticides, PCBs, PBDEs, PFAS, phthalates and triclosan will be quantified in cases whose sons develop testicular cancer during 40 year follow up and compared to controls.
Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer
Testicular CancerStudy Objectives: Primary objective The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP. Secondary Objectives Overall survival Progression free survival Response rates (RECIST) Duration of response To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP
Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors
Adult Central Nervous System Germ Cell TumorAdult Teratoma8 moreThis phase II trial studies how well palifosfamide works in treating patients with recurrent germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing