Albert Lea

This trial investigates the effectiveness of elacestrant compared to standard endocrine therapy for adults with node-positive, estrogen receptor-positive (ER+), HER2-negative early breast cancer who are at high risk of recurrence. The study aims to understand if elacestrant can improve outcomes in this group over standard treatments. Participants will be randomly assigned to receive either 345 mg of elacestrant once daily for five years or continue with their previous standard endocrine therapy, which may include anastrozole, letrozole, exemestane, or tamoxifen. Both treatments are taken orally, and the study is open-label, meaning participants and researchers know which treatment is given. During the study, participants will be monitored for up to five years for outcomes such as invasive breast cancer-free survival, distant relapse-free survival, overall survival, and quality of life changes. Assessments include questionnaires on health status and physical functioning, symptom evaluation, and blood tests to measure elacestrant levels. Safety and adverse events will be tracked throughout and for 28 days after treatment ends.

Researchers are studying the immediate and long-term effects of structured breathing exercises on mental health symptoms such as anxiety, depression, stress, and sleep quality. The study focuses on healthcare professionals experiencing burnout and aims to assess how these breathing practices might support their mental well-being. This behavioral intervention is sponsored by Mayo Clinic and targets adults aged 18 to 85 years. Participants will engage in self-guided structured breathing sessions lasting 15, 30, or 36 minutes, tailored to their personal skill level. The study monitors the feasibility, acceptability, and appropriateness of these breathing exercises over a four-month period. The intervention is delivered via a mobile app, allowing participants to practice breathing exercises on their own schedule. During the study, participants will be assessed on recruitment ease, retention, mobile app engagement, satisfaction with the breathing intervention, and adherence to the program. Researchers will collect data through mobile app usage metrics and self-reported measures to evaluate how well the intervention fits into the participants' routines. The total participation time for each individual is four months, during which their progress and experience with the breathing practice will be closely monitored.

Researchers are evaluating quality of life changes after two different radiation treatments for localized prostate cancer in men. The study compares near margin-less adaptive radiation therapy (ART), which uses treatment feedback to adjust future doses and aims to reduce exposure to healthy tissue, with standard stereotactic ablative body radiotherapy (SABR), which delivers radiation in smaller doses over several days. The study focuses on early and late patient-reported quality of life and side effects related to bowel and urinary symptoms, as well as other clinical outcomes. Participants are randomly assigned to one of two groups. One group receives near margin-less ART in two treatments spaced at least three days apart, with imaging procedures including cone beam CT and possibly CT or MRI scans. The other group receives standard SABR in five treatments spaced at least two days apart, also with CT or MRI imaging. Treatment continues as long as there is no disease progression or unacceptable toxicity. Follow-up visits occur at 1, 3, and 6 months after treatment, then every 6 months for up to 5 years. During the study, patients complete questionnaires on quality of life, erectile function, prostate symptoms, and financial impact. Researchers monitor side effects, disease progression, and survival using clinical exams, imaging, and laboratory tests such as PSA levels. The main outcome is patient-reported early quality of life within 3 months after treatment. Long-term monitoring includes up to 5 years of follow-up to assess disease control and side effects. The study aims to identify whether shorter ART treatment can maintain effectiveness while reducing quality of life impacts compared to standard SABR.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors (ICIs). The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are evaluating how well proton beam radiation therapy compares to intensity modulated photon radiotherapy in treating patients with stage I-IVA esophageal cancer. This phase III trial aims to determine whether proton beam therapy improves overall survival and reduces serious heart and lung side effects compared to photon radiotherapy. The study also examines symptom burden, quality of life, treatment costs, and disease control outcomes. Participants are randomly assigned to one of two treatment groups. One group receives proton beam therapy over 28 sessions in 5.5 weeks alongside chemotherapy with drugs like carboplatin, paclitaxel, or fluorouracil-based regimens. The other group receives intensity modulated photon radiotherapy on the same schedule with similar chemotherapy options. Both groups undergo blood sample collection and imaging scans such as PET/CT or CT during treatment. Surgery to remove the esophagus is considered within 4 to 8 weeks after therapy if feasible. Throughout the study, participants will have follow-up visits every 3 to 6 months for three years, then annually afterward. Researchers will monitor survival, heart and lung toxicities, immune cell counts, symptom changes, hospital stays, and cancer progression. Patient-reported outcomes and quality-of-life measures are collected, along with biospecimens for future biomarker analysis. This comprehensive monitoring will help assess the benefits and risks of each radiation approach over time.

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 studying hair loss caused by endocrine therapy in both postmenopausal and premenopausal women with breast cancer. Hair loss is a common and distressing side effect of cancer treatments, and this study aims to better understand how often it occurs, its timing, duration, and severity, especially related to different types of endocrine therapies. The study compares women receiving tamoxifen, aromatase inhibitors, aromatase inhibitors with CDK4/6 inhibitors, and those not receiving endocrine therapy. This observational study involves patients completing questionnaires and surveys about their hair loss. Medical records will also be reviewed to gather information. The study includes four main groups of postmenopausal women and a premenopausal group that has already completed enrollment. Participants answer questions every three months, starting within two weeks of beginning endocrine therapy or CDK4/6 inhibitor treatment. Participants will provide detailed reports about their hair loss symptoms and complete regular surveys to measure the impact on quality of life. Researchers will analyze patient-reported data on hair loss incidence and severity up to two years. The study helps characterize treatment-related alopecia and its effects, supporting better understanding of this side effect during breast cancer therapy.

This research aims to evaluate the feasibility of a structured breathing intervention called Seokmun Hoheup in adolescents aged 12 to 17 years diagnosed with mild to moderate anxiety and/or depression. The study focuses on both rural and non-rural adolescents who receive care at outpatient pediatric and child/adolescent psychiatry clinics. The purpose is to understand how this breathing practice might support mental health in this group. Participants will follow the structured breathing program at least three times per week. The practice begins with 15-minute sessions and gradually increases to 30 and then 36 minutes over the course of the program. This intervention is behavioral and is designed to be performed regularly by the adolescent patients throughout the study. During the study, researchers will assess feasibility, acceptability, and appropriateness of the breathing intervention after four months using standardized measures. They will also monitor recruitment and retention rates, system usability, total log-ins, and completion rates of assigned breathing sessions. Participants will be involved over four months, with evaluations based on their engagement and feedback regarding the breathing practice.

Researchers are investigating how changes in the gut bacteria (microbiome) might be linked to fatigue and chemotherapy-induced nausea (CIN) in women with early stage breast cancer. Since patients receiving chemotherapy often experience these symptoms, this observational study aims to explore why some patients have more fatigue and nausea than others, focusing on the role of the gut microbiome. The study is supported by Mayo Clinic and collects data before and after chemotherapy treatment. Participants provide stool and blood samples before starting chemotherapy and again 3 to 5 days after chemotherapy begins. They also complete questionnaires about their symptoms, food intake, exercise, and other health factors. The study observes changes in gut bacteria composition and metabolites to understand their connection to fatigue and CIN during chemotherapy. During the study, patients are asked to complete questionnaires and provide biological samples at two time points: before chemotherapy and shortly after treatment starts. Researchers monitor the bacterial makeup of stool samples and compare demographic and clinical characteristics between patients who do and do not report fatigue or nausea. The study tracks recruitment, retention, and the completion of study assessments over up to 24 months, aiming to better understand symptom differences related to chemotherapy.