Avon

Researchers are evaluating the safety and feasibility of a daily 3-minute hand-held vibration therapy to reduce the severity of chemotherapy-induced peripheral neuropathy CIPN in the hands. This pilot study aims to gather early data on the feasibility, safety, and potential benefits of this therapy to improve CIPN-related quality of life. The goal is to use these results to support future trials exploring vibration therapy as a treatment option for CIPN. Participants will use a hand-held vibrating device daily, holding it on each hand for 3 minutes over a 4-week period. This intervention is designed to be simple and self-administered. There are no comparator groups mentioned, and the focus is on monitoring the therapys acceptability and compliance during this time. During the study, researchers will track recruitment rates, adherence to therapy sessions, and patient acceptance of the intervention. They will measure changes in CIPN severity and quality of life using validated questionnaires at baseline and weekly throughout the 4 weeks, with additional follow-ups up to 8 weeks. Participants must return to the clinic for assessments at specified intervals to support these evaluations.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are studying the effects of exercise in adults with indolent metastatic breast cancer who have not had disease progression in the past 12 months and are not receiving cytotoxic chemotherapy. The study aims to see if a 16-week virtual, supervised exercise program combining aerobic and resistance training can improve heart and lung fitness, physical function, muscle mass, and patient-reported quality of life measures. This trial is a randomized, two-arm study comparing exercise to usual care in this specific patient group. Participants are randomly assigned to either an exercise intervention or usual care. Those in the exercise group will work with a trainer three times a week for 16 weeks in virtual sessions lasting 60 minutes. Each session includes cardiovascular exercise, resistance training, and balance or stretching exercises, with intensity adjusted based on heart rate and perceived exertion. The usual care group receives standard care and educational handouts encouraging exercise but no structured program. Throughout the study, participants will undergo tests to measure cardiorespiratory fitness, physical performance, muscle and fat composition via CT scans, and physical activity tracking. Patient-reported outcomes like fatigue and quality of life will also be assessed at baseline, 8 weeks, and 16 weeks. Researchers will monitor adherence to the exercise program and evaluate changes in physical and patient-reported measures to understand the impact of the intervention over the 16-week period.

Researchers are evaluating durvalumab, an immunotherapy drug, compared to standard patient observation after surgery in patients with early-stage non-small cell lung cancer who have no remaining cancer cells. This phase III trial aims to determine if durvalumab can improve outcomes such as disease-free survival and overall survival compared to the usual approach of monitoring without additional treatment. The study also assesses quality of life, side effects, and patient-reported symptoms. Participants are randomly assigned to one of two groups. One group receives durvalumab intravenously once every 28 days for up to 12 cycles unless the disease progresses or side effects become unacceptable. The other group undergoes active surveillance with regular monitoring. Both groups have computed tomography scans and blood samples collected throughout the 12-month study period. After treatment or observation, patients are followed annually for up to 10 years. Participants will complete questionnaires about their quality of life and symptoms. Researchers will monitor disease recurrence, new lung cancers, and overall survival for up to 10 years. Blood tests and imaging scans will be used to track health status and side effects. Safety and adverse events are evaluated during and after treatment, with long-term follow-up to assess the durability of outcomes.

Researchers are evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

This research aims to explore the feasibility of adding pelvic health physical therapy before radiation treatment for women diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer who are candidates for curative pelvic external beam radiation. The study focuses on addressing side effects like pelvic pain and painful intercourse, which can affect quality of life after treatment. It seeks to understand challenges and benefits of coordinating pelvic health therapy with standard radiation care. Participants will receive education on using a vaginal dilator, a device designed to help maintain vaginal canal openness and stretch pelvic floor muscles, during their radiation treatment. The study combines pelvic health therapy involving assessments and vaginal dilator education with standard radiation therapy, delivered in collaboration between physical therapists and radiation oncology staff. Treatment includes physical therapy evaluations, questionnaires, and ongoing support throughout the radiation period. During the study, participants will complete questionnaires on pain and sexual function at various points including immediately after radiation and up to 16 weeks post-treatment. Researchers will monitor adherence to vaginal dilator use and assess pelvic pain using a pain rating scale. The main outcome is to evaluate the feasibility of this pre-rehabilitation approach alongside radiation therapy. The total participation duration covers baseline through several follow-up assessments over months after radiation.

Researchers are evaluating a survival prediction tool developed by Lee et al for patients with metastatic cancer referred to radiation oncology for palliative treatments. This phase II clinical trial aims to test the tools ability to predict 30-day survival based on objective data such as laboratory values, emergency room visits, and primary cancer origin. Patients will be assigned a score reflecting their mortality risk, categorized as low, intermediate, or high risk. The study uses a single-arm design where each participant receives a survival prediction score ranging from 0 to 20, with higher scores indicating worse survival prognosis. The prediction tool incorporates several laboratory measures and clinical history to calculate this score at enrollment. Patients may or may not receive palliative radiation therapy as part of their care, and completing radiation treatment is not required for participation. Risk groups are defined as low 0-6, intermediate 7-13, and high 14-20 scores. Participants will be monitored for survival and quality of life at 30, 90, and 365 days after enrollment. Quality of life will be assessed using the FACIT-Pal-14 questionnaire. Follow-up visits may be in person or virtual. The primary outcome is 30-day survival of the high-risk group, while secondary outcomes include survival across all risk groups at various time points and patient-reported quality of life. The total study duration for participants is one year from enrollment.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.