View clinical trials related to Vulvar Neoplasms.
Filter by:In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).
This randomized clinical trial studies a palliative care program in improving the quality of life of patients with high-risk gynecologic malignancies that is original or first tumor in the body (primary) or has come back (recurrent). Palliative care is care given to patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a palliative care program may help doctors learn more about patients quality of life, use of healthcare services, and the relief of pain.
Women affected by gynaecologic cancers are often not aware of sexual consequences of cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the impact on their sexuality may be profound. Despite this several potential therapies can be effective in helping recovery. A major challenge is informing and involving the patients in an appropriate and sensitive manner, and a further issue is the delivery of such therapies in busy and medically driven gynaecologic oncology clinics. It will use and adapt existing evidence based therapies for improving sexual function after cancer treatment and develop a model for delivering these in the NHS (United Kingdom National Health Service) setting. The model of 'stepped care' is adapted from that used nationally and successfully in the Increasing Access to Psychological Therapies (IAPT) programme. Assessment allows for 'stepping up and down', i.e. calibrating the type of help a woman receives according to need and her response to treatment already given.This study will develop and evaluate a 'stepped' system of interventions using elements of best available evidence, adapting existing interventions to help women recover their sexual feelings and activity, starting with simple methods, moving on to new talking treatments for more complex cases. The investigators address all gynaecologic cancers on the principle that sexual difficulty is the problem the investigators are treating, not the cancer of origin. Ongoing clinical assessment will be vital for the success of the stepped care model. The investigators will deliver training and supervision to enhance the skills needed by the Clinical Nursing Specialist (CNS). An important part of this study will be characterising the range of women and their willingness to participate in psychosexual help. One-to-one follow up interviews will inform the level of input required for any subsequent Randomised Control Trial (RCT). The investigators will use internationally recognised rating scales for rating sexual function, assess how illness and treatment affect mood and self esteem. The investigators will also measure the overall cost-effectiveness to the public sector of providing this treatment, compared to costs of subsequent use of health and social services. This pilot study will assess the feasibility of conducting a full scale investigation of a stepped therapy and indicate the potential benefits to the patients, their partners, and to the NHS generally.
This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.
Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment. This is a research study using special immune system cells called HPVST cells, a new experimental treatment. Investigators want to find out if they can use this type of treatment in patients with HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the blood of patients with HPV-cancers. They want to see if these special white blood cells, called HPVST cells, that will have been trained to kill HPV infected cells can survive in the blood and affect the tumor. They will also see if they can make the T cells more active against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that these HPV-cancers produce. They will grow these HPVST cells from the patient's blood. The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long they last in the body, to learn what the side effects are and to see if the HPVSTs will help people with HPV associated cancers. If the treatment with HPVST cells alone proves safe (Group A), additional group of patients (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment. Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby giving them room to expand. The purpose of this part of the study is to find out if TGF-beta resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body and if they are more effective than HPVST cells alone in controlling the tumor.
This trial studies the prevalence of anal dysplasia and anal cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer. Studying samples collected from patients in the laboratory may help doctors learn more about the human papillomavirus and how often anal cancer occurs in patients with cervix, vagina, or vulvar cancer.
This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.
Vulvar cancer is a rare disease that is treated with surgery, radiation and chemotherapy. When tumors are large (greater than 4 cm) or compromise the urethra (urine canal) and the anus, or when it is in the groin lymph nodes, surgery alone is not always able to be performed. In this circumstance, is necessary to add radiotherapy, chemotherapy or both . So far it is not known the best sequence of treatment: surgery, chemotherapy or radiotherapy. The radical surgeries usually need long recovery term both in the region of the vulva and in the region of the groin lymph nodes. When it is performed, convalescence can delay other treatments, like radiotherapy and chemotherapy. On the other hand, the use of radiotherapy and chemotherapy as a first step treatment can result in a complete elimination of the disease in at least 30% of the cases or substantial reduction of its size, allowing less extensive surgery. Investigators intend to use surgery, chemotherapy and radiotherapy in the treatment of vulvar cancer, but in a sequence that has not been studied, in order to increase benefits of these treatments, and reduce morbidity. This study will be offered to patients who have disease of the vulva less than 4 cm (sentinel lymph node), or greater than 4 cm, or illness that compromises urethra and anus, or patients with disease in groin lymph nodes (glands). 1. On the eve of the surgery, investigators will inject dextran-70 labeled with technetium-99 m. Only patients with tumors smaller than 4 cm will do this procedure. 2. On the day of the surgery, the groin lymph nodes will be removed from the inguinal (groin) only. If lymph nodes are disease positive, the vulvectomy will not be performed at this time. Patients will be treated with radiation therapy with concomitant chemotherapy for approximately six weeks. 3. At the end of treatment with chemotherapy and radiotherapy, investigators will perform a surgery to remove the remaining tumor in the vulva.
In vulvar neoplasia, even minor surgical interventions cause multiple symptoms, symptom distress and complications, which have an impact on a woman's quality of life and contribute to high health care costs. For the majority of the patients, symptom and distress can be reduced if adequate treatment is provided. This study aims to test possible differences between the impact of standardized care and the WOMAN-PRO II program on symptom prevalence in women with vulvar neoplasia after surgical treatment. In a sequential explanatory mixed-methods project, a randomized phase II study will be followed by a qualitative sub-study. Ninety patients with vulvar neoplasia treated surgically will participate in the randomized trial in four Swiss hospitals and one Austrian hospital. After stratification by precancer/cancer, women will be randomly assigned (1:2 ratio) to standardized care and the WOMAN-PRO II program. The standardized care group will receive a set of information leaflets about supportive care options in the clinic. The WOMAN-PRO II program group will obtain counseling sessions by specially trained gynecology-oncology nurse specialists at the moment of diagnosis, 7 days post-surgery, in week two after discharge, week twelve and week 24 after surgery. The primary outcome of this study is symptom prevalence. Secondary outcomes will be collected for explorative reasons and include symptom distress, uncertainty, quality of life, social support, resilience, quality of care, sociodemographic and medical characteristics, post-surgical complications, functional status, cost evaluation and process outcomes. Quantitative data will be collected at the counseling points of time and analyzed by using mixed linear regression analysis. Twenty interviews will be conducted with women of the WOMAN-PRO II program group. A focus-group interview will be conducted with twelve gynecology-oncology nurse specialists in order to better understand to which degree the interventions meet individual needs as well as to identify remaining barriers and enablers for the implementation of symptom self-management. Qualitative data will be analyzed by using thematic analysis and a critical hermeneutic reflection. This study will evaluate the impact of the WOMAN-PRO II program on symptom prevalence, patient-reported outcomes and clinical parameters, and inform the design of a possible phase III study on the clinical efficacy of the program.
The objective of this study is to evaluate the sensitivity and specificity of two nutrition screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools are in the form of scored questionnaires and are suitable for electronic input. The ultimate objective is to select an adult inpatient nutrition screening tool with the highest sensitivity for future use in the oncology inpatient setting in order to allow prompt commencement of an appropriate nutrition care plan.