Avon

This research aims to determine the safety and feasibility of using a daily 3-minute hand-held vibration therapy to reduce the severity of chemotherapy-induced peripheral neuropathy (CIPN) in the hands. The study focuses on patients who have completed chemotherapy at least 60 days prior and continue to experience sensory neuropathy in their hands. Researchers hope this pilot study will provide early information on the therapy's feasibility, effectiveness, and safety to support future clinical trials for treating CIPN. Participants will use a hand-held vibration device daily for three minutes as the main intervention. The study measures the feasibility of recruitment and compliance, the acceptability of the intervention, and changes in neuropathy severity using the CIPN20 quality of life questionnaire over four weeks. The study includes a recruitment period lasting up to five years, with assessments at baseline and weekly for four weeks. Participants will be asked to attend clinic visits for required study measurements at scheduled intervals. Researchers will monitor recruitment rates, therapy session completion, participant agreement with the intervention, and quality of life changes related to neuropathy symptoms. Safety and feasibility will be carefully evaluated throughout the study to guide future research on vibration therapy for CIPN treatment.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating the effects of a virtual, supervised exercise program on patients with indolent metastatic breast cancer, a form of breast cancer that has not progressed in the past 12 months and who are not receiving cytotoxic chemotherapy. This study aims to determine whether 16 weeks of progressive aerobic and resistance training can improve cardiorespiratory fitness, functional status, muscle mass, and patient-reported outcomes, all of which are important predictors of survival in this population. The trial is randomized, with participants assigned to either an exercise group or usual care to compare these effects over a 16-week period. Participants randomized to the exercise group will engage in 60-minute training sessions three times per week for 16 weeks, conducted virtually via a secure video platform. The exercise sessions include cardiovascular work, resistance training, and balance or stretching exercises, with intensity guided by heart rate monitors and perceived exertion to maintain moderate intensity. Training schedules are personalized and supervised by exercise trainers who adjust intensity based on participant feedback and heart rate data. Additionally, participants receive education on creating and maintaining behavior changes. The control group receives usual care without the structured exercise intervention. During the study, researchers will monitor changes in cardiorespiratory fitness using a treadmill test at baseline and after 16 weeks. They will also assess physical function through objective tests and questionnaires, measure body composition using CT scans, and track physical activity with accelerometers. Patient-reported outcomes such as fatigue and quality of life will be collected. The study will evaluate adherence to the exercise program and factors influencing participation. The entire study duration for participants is 16 weeks of active intervention and assessment.

Researchers are evaluating durvalumab, an immunotherapy drug, compared to the usual approach of patient observation after surgery in people with early-stage non-small cell lung cancer (NSCLC) who have no remaining cancer cells following standard treatment. This phase III trial aims to determine if durvalumab can improve disease-free survival and overall survival, as well as assess its safety and impact on quality of life. The study focuses on participants with stage II to IIIB NSCLC who achieved a complete response after neoadjuvant chemo-immunotherapy and surgery. Participants are randomly assigned to one of two groups: one group receives durvalumab intravenously every 28 days for up to 12 cycles if there is no disease progression or unacceptable side effects, while the other group undergoes active surveillance without additional treatment for 12 months. Both groups have regular computed tomography (CT) scans and blood sample collections during the study. After treatment or surveillance, participants are followed annually for up to 10 years. Throughout the study, participants complete questionnaires about their quality of life and report symptoms such as rash or numbness. Researchers monitor disease recurrence, new lung cancers, or death, as well as treatment side effects. Specimens and images are collected for future research. The total participation time includes treatment or observation plus long-term follow-up visits to assess the effects and safety of durvalumab compared to observation alone.

Researchers are investigating whether observation is as effective as continuing pembrolizumab treatment in patients with early-stage triple-negative breast cancer who achieved a complete response after preoperative chemotherapy combined with pembrolizumab. This phase III trial aims to evaluate recurrence-free survival and quality of life, as well as the value of reducing immunotherapy treatment after surgery in these patients. The study also examines differences in adverse events, overall survival, and financial impacts between treatment approaches. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group receives pembrolizumab intravenously as adjuvant therapy, while the other group undergoes observation without further treatment. Both groups have tumor biopsies and blood samples collected on study and during follow-up. Additional assessments include questionnaires and quality-of-life evaluations. During the study, researchers monitor participants for up to 10 years to measure recurrence-free survival. They assess quality of life using validated tools, track adverse events, and evaluate financial toxicity and work productivity. The study includes tumor tissue analysis, blood sample collection, and patient-reported outcomes to understand the long-term effects and value of treatment de-escalation in breast cancer care.

Researchers are exploring the feasibility of adding pre-rehabilitation pelvic health physical therapy to the standard radiation therapy plan for female patients diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer who are candidates for curative pelvic radiation using external beam. This pilot clinical trial aims to identify barriers and facilitators to implementing pre-rehabilitation services and to evaluate the potential clinical benefits of pelvic health services focused on vaginal dilator education and use to reduce pelvic pain and painful intercourse after radiation treatment. Participants will receive pelvic health therapy that includes education on vaginal dilator use, physical therapy evaluations with pelvic floor muscle examinations, and completion of questionnaires assessing sexual function and pain levels. The study involves collaboration between radiation oncology and pelvic health physical therapy teams to provide coordinated care before and during radiation treatment. During the study, participants will complete assessments such as the Female Sexual Function Index and VAS Pain Scale questionnaires, as well as adherence tracking to vaginal dilation through patient questionnaires. Researchers will monitor the feasibility and potential clinical impact of the pre-rehabilitation program from baseline up to six weeks and four months after starting radiation therapy, focusing on reducing pelvic pain and sexual dysfunction. The total participation duration includes these follow-up periods to assess treatment outcomes and safety.

Researchers are evaluating a survival prediction tool designed by Lee et al for patients with metastatic cancer referred to radiation oncology for palliative treatments. This phase II clinical trial tests how well the tool predicts 30-day survival using objective data such as laboratory values, emergency room visits, and the primary cancer type. Patients receive a score from 0 to 20, with higher scores indicating worse survival outlook. The study aims to confirm that patients scoring above 14 have less than a 20% chance of surviving 30 days. At enrollment, each patient is assigned a survival prediction score based on lab results including white blood cell count, neutrophil-lymphocyte ratio, blood urea nitrogen, bilirubin, albumin, lactate dehydrogenase, red cell distribution, number of emergency room visits in the past 100 days, radiation therapy site, and cancer type. This score categorizes patients into low-risk (0-6), intermediate-risk (7-13), and high-risk (14-20) groups. The study involves a single-stage, single-arm design focused on validating this scoring tool. Participants' survival and quality of life are monitored at 30, 90, and 365 days after enrollment. Quality of life is assessed using the FACIT-Pal-14 questionnaire. The main outcome measured is 30-day survival for the high-risk group with scores above 14. Follow-up may be done in person or virtually. The study includes patients whether or not they receive or complete palliative radiation therapy, with the total participation lasting up to one year for survival and quality of life assessments.

This research aims to compare the effects of usual care including regional radiation therapy with no regional radiation therapy in women with low-risk breast cancer. It focuses on patients with node positive breast cancer or T3N0 disease who typically receive endocrine therapy and possibly chemotherapy to prevent cancer recurrence. The study examines whether skipping regional radiotherapy still effectively prevents breast cancer from returning, potentially reducing unnecessary treatment and side effects. Participants will be divided into two groups: one receiving radiotherapy to the breast/chest area and surrounding lymph nodes, and the other receiving no regional radiotherapy. The study evaluates standard treatments, ensuring radiation therapy starts within specific time frames after surgery or chemotherapy. Treatments include breast-conserving surgery or mastectomy, along with endocrine therapy planned for at least five years. During the study, researchers will monitor breast cancer recurrence-free intervals over approximately 9.5 years. Participants will undergo regular assessments to track cancer status, side effects, and overall health. The study includes quality of life questionnaires for some patients and requires ongoing follow-up to document treatment effects, adverse events, and long-term outcomes.