Lapeer

Researchers are investigating whether adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy using the TheraBionic P1 device can affect the pathological response in patients with resectable early-stage breast cancer. This study focuses on women with hormone receptor-positive, HER2-negative breast cancer who are planning upfront surgery. The research is designed to evaluate the treatments impact before surgery in a neoadjuvant setting. Participants will self-administer the TheraBionic P1 device therapy three times a day for 60 minutes each sessionmorning, midday, and eveningover approximately two weeks before their scheduled tumor resection surgery. This device delivers amplitude-modulated electromagnetic fields continuously during these sessions. The study does not include a comparison group or blinding. During the trial, participants will have their tumor tissue evaluated for pathological response at the time of surgery. Researchers will also analyze changes in microRNA, Ki-67, tumor apoptosis marker Cleaved caspase-3, and cell cycle arrest marker p27 from baseline to post-surgical tissue. Long-term follow-up will assess overall survival and progression-free survival for up to five years after surgery. Participants will be monitored for safety and treatment adherence throughout the study period.

Researchers are evaluating the combination of amplitude-modulated radiofrequency electromagnetic fields AM RF EMF and Fruquintinib in adults with metastatic colorectal adenocarcinoma that has not responded to standard treatments. This Phase 2 study aims to determine if adding AM RF EMF to Fruquintinib improves survival while being safe and tolerable. The trial focuses on patients whose cancer has progressed despite previous therapies targeting RAS, BRAF, MSIMMR, and HER2 markers. Participants receive treatment with the TheraBionic P1 device delivering AM RF EMF three times daily continuously, alongside daily doses of Fruquintinib taken orally in cycles of three weeks on treatment followed by one week off. This combined therapy is studied throughout the treatment period, with careful monitoring of safety and tolerability. Throughout the study, participants undergo regular assessments including imaging scans CT, MRI, or PET to evaluate disease status, and blood tests to measure biomarkers like carcinoembryonic antigen CEA and microRNA levels. Researchers will track overall survival up to five years post-treatment or until death. Safety is monitored during treatment and for 28 days after device discontinuation. The total participation duration varies as outcomes are followed long term.

Researchers are evaluating the Ask Questions about Clinical Trials ASQ-CT brochure, a communication tool designed to improve conversations between patients and healthcare providers about clinical trials. This trial focuses on patient-provider communication and provider invitations to clinical trials among adults with oncology, cardiac disease, or neurologic disorders who are potentially eligible for clinical trials. The study is conducted by the Barbara Ann Karmanos Cancer Institute and is a health services research trial. Participants receive the ASQ-CT brochure at the baseline visit Time 1 as the main intervention. They complete questionnaires at three timepoints baseline Time 1, before their research visit Time 2, and after their research visit Time 3. The brochure serves as a question prompt list aimed at facilitating communication about clinical trials. Throughout the study, participants answer surveys that measure their confidence in managing patient-provider interactions, knowledge about clinical trials, trust, and distress levels at different timepoints. The researchers also track how many participants engage with the brochure and how well the intervention is implemented over up to three months. The total participation duration spans from the initial baseline questionnaire to the post-research visit follow-up.

This study aims to collect prospective safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis, following standard care practices. The research focuses on patients with lower extremity pareses who are fitted with the C-Brace device. The goal is to better understand how the C-Brace influences walking speed, balance, risk of falling, and confidence in balance over time. The C-Brace is a custom-made device with thigh, calf, and foot components connected by an ankle joint or spring element. It uses sensors to continuously monitor knee joint movement and walking phases, adjusting hydraulic resistance and knee motion accordingly. Patients enrolled in the registry will undergo baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after fitting. Participants will be assessed through various tests including timed walk tests, balance confidence scores, and mobility assessments at different intervals. The study also tracks falls related to device use and changes in activity levels with an activity tracker. Data collected will help characterize the safety and functional impact of the C-Brace over three years of follow-up.

Researchers are comparing two types of radiation therapy, proton beam radiation therapy PBT and intensity modulated photon radiotherapy IMRT, to treat patients with stage I to IVA esophageal cancer. The study aims to find out whether PBT improves overall survival and causes fewer serious heart and lung side effects compared to IMRT. Additional goals include examining symptom burden, quality of life, tumor response, cost-effectiveness, hospitalization length, lymphocyte levels, and rates of treatment failures and complications. Participants are randomly assigned to one of two groups. One group receives PBT over 28 treatment sessions, five days a week for 5.5 weeks, combined with chemotherapy chosen by the patient and their doctor. The other group receives IMRT on the same schedule with similar chemotherapy options. After chemoradiation, patients may have surgery to remove the esophagus tumor if they are eligible. Throughout the study, blood samples and imaging scans PETCT or CT are collected. Participants are closely monitored during treatment and followed for up to eight years. Follow-up visits occur every 3 to 6 months for the first three years and annually thereafter. The study measures overall survival, heart and lung side effects, symptom changes, tumor response, hospitalization time, immune cell counts, and quality-adjusted life years. The study also collects biospecimens for future research on treatment complications and assesses economic factors related to each radiation therapy.

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 investigating whether adding the drug Docetaxel to the usual hormone treatments, Androgen Deprivation Therapy ADT and Androgen-Receptor Pathway Inhibitor ARPI, can better control metastatic castration sensitive prostate cancer in men who have not responded optimally to initial hormone therapy. This phase III, international, open-label, randomized trial seeks to compare the effectiveness of this combined approach against the standard hormone therapy alone. Participants will be randomly assigned to receive either the standard hormone therapy with ADT plus ARPI or the same hormone therapy combined with Docetaxel chemotherapy. The trial focuses on men with metastatic prostate cancer who continue to have elevated PSA levels after 6 to 12 months of hormone-targeting treatment. Treatments are administered according to physician choice and assignment, and the study evaluates outcomes over a long period. During the trial, participants will be closely monitored with assessments including PSA levels and clinical progression over 39 months. Researchers will measure overall survival as the primary outcome, along with secondary outcomes such as PSA progression, PSA response, PSA kinetics, and progression-free survival. Participants must be accessible for treatment and follow-up to allow for complete documentation of treatment effects and adverse events throughout the study duration.

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 evaluating the combination of nab-paclitaxel, gemcitabine, and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device called TheraBionic P1 for patients with metastatic pancreatic adenocarcinoma. This Phase 2 trial aims to find out if this combined treatment is safe and effective for this advanced cancer. Participants will receive standard chemotherapy with nab-paclitaxel and gemcitabine administered weekly in specific doses through infusions. Alongside chemotherapy, the TheraBionic P1 device delivers low-level radio waves into the body via a spoon-shaped antenna placed in the mouth three times daily for one hour each session. This treatment plan continues as scheduled during the study. Throughout the study, participants will have multiple assessments including imaging scans to measure tumor response and progression. Researchers will monitor progression-free survival at 6 months as the primary outcome, along with other measures such as overall survival, adverse events, and disease control over up to one year. Participants will be closely observed for safety and treatment effects during the study period, which runs until July 2027.

Researchers are evaluating the safety of Metformin alone and combined with chemotherapy or immunotherapy in patients with advanced solid tumor cancers. This Phase I study aims to identify the toxicities of Metformin at different dose levels and determine the maximum tolerated dose when used with chemotherapy or immunotherapy. Participants are adults who have measurable disease and are suitable candidates for these treatments. Participants will receive standard chemotherapy andor immunotherapy based on their disease and stage. Initially, they will take Metformin alone for 14 days between the first and second chemotherapy cycles to assess tolerability. From the second cycle onward, Metformin will be taken daily alongside their standard cancer treatments, with doses ranging from 1000mg to 3000mg as part of a dose escalation. During the trial, participants will be monitored for dose-limiting toxicities both during the Metformin-only period and while receiving combination treatment. Researchers will assess the maximum tolerated dose and evaluate overall response rate, duration of response, and progression-free survival up to four months after treatment begins. Safety and treatment effects will be carefully tracked throughout the study, which runs until July 2028.