Proton Therapy

Skin rejuvenation aims to improve the signs of skin aging, which involve changes in the skin's layers including reduced collagen leading to thinner skin, laxity, and wrinkles. This trial evaluates and compares two types of laser therapies, fractional CO₂ laser and long-pulsed 1064-nm Nd:YAG laser, both used to stimulate collagen production and improve skin condition. The goal is to assess their effects on dermal thickness, skin elasticity, wrinkles, and overall aesthetic improvement in adults aged 30 to 59 with moderate skin aging.

This research aims to compare how different laser wavelengths (808 nm, 980 nm, and 1064 nm) affect nerve healing in patients with Bell's palsy, a condition causing facial paralysis and movement problems. By studying these laser treatments, researchers hope to improve clinical care, rehabilitation methods, and quality of life for people with this nerve disorder. Participants are randomly assigned to one of four groups: a sham laser device group, a Low-Level Laser Therapy group, a gallium arsenide diode laser group, or a high-intensity laser treatment group. Each group receives 18 treatment sessions over six weeks, with three sessions each week. All participants also receive facial muscle massage and exercises to support nerve recovery. During the study, researchers will assess the facial nerve function using compound motor action potential tests at the start and after six weeks of treatment. Other assessments include facial disability scoring and monitoring of therapy sessions. The total study period includes the six-week treatment phase, with safety and progress tracked throughout.

Fallopian tube obstruction is a common health issue affecting many women and can lead to infertility and other reproductive problems. Researchers are studying laser acupoint therapy as a possible treatment to improve the function of the fallopian tubes by using focused laser light directed at specific points linked to reproductive health. This noninvasive and painless therapy may offer benefits over traditional acupuncture by activating the body's energy pathways to support healing. Participants in this study will be randomly assigned to one of two groups. One group will receive laser acupoint therapy combined with standard care, while the other group will receive a placebo laser acupoint therapy along with standard care. The treatment aims to assess the effect of laser acupoint therapy on fallopian tube obstruction, with no blinding involved. The study starts with treatment and includes follow-up assessments 3 months after treatment. Women who join the study will undergo evaluations including tests to measure tubal patency, anti-Müllerian hormone levels, and pregnancy status three months after treatment. Researchers will monitor these outcomes to understand the therapy's impact. Participants must be able to attend all scheduled sessions and follow-up visits. The study is led by Kafrelsheikh University and runs from April 2025 to April 2026.

Researchers are investigating the use of high-energy laser therapy to treat thumb osteoarthritis, a degenerative joint disease that affects the hand and causes pain, deformity, and limited movement. This condition can significantly limit daily activities, especially when it involves the trapeziometacarpal joint, known as rhizarthrosis. Many treatments like medications, exercises, physical therapy, and orthoses help manage hand osteoarthritis, but surgery may be needed when these conservative treatments fail. The study compares two approaches: high-energy multimodal laser therapy using the Ixyon XP device, which delivers multiple wavelengths and is administered in 10 sessions on alternate days, versus a group performing home exercises designed to improve thumb joint stability over 4 weeks. Both groups will use a brace during the day for 4 weeks. The laser therapy aims to reduce inflammation, improve blood flow, and relieve pain by stimulating cellular activity in the affected tissues. Participants will be monitored for pain relief at 1, 3, and 6 months after treatment begins. Researchers will also assess functional recovery, disability improvement, and the participants' perception of clinical progress over 6 months. The study involves regular evaluations of pain using a visual scale and assessments of hand function and disability to understand the benefits of high-energy laser therapy compared to exercise alone.

Proton therapy is a cancer treatment similar to standard radiation therapy but uses unique particles that may reduce side effects and improve disease control. This trial focuses on collecting data to support the development and safety of proton therapy, which is currently available only for select diseases in Italy following national guidelines. The study is observational and aims to gather real-world information over an extended period. Participants in this study will receive proton therapy as part of their clinical care based on medical indications. The therapy is administered according to standard practice without experimental modifications. This study does not compare proton therapy to other treatments but observes outcomes from patients treated with this method. During the study, researchers will collect data from enrollment through 10 years, monitoring treatment side effects, identifying biomarkers, optimizing treatment planning, assessing secondary cancer risks, and evaluating quality of life. Participants will be followed long term to observe treatment adherence, outcomes in rare tumors, and overall safety. The total participation time may extend up to 10 years for comprehensive data collection.

Researchers are studying chordomas and chondrosarcomas, which are malignant bone tumors located in the axial skeleton including the clivus, spine, and sacrum. These tumors mainly cause problems due to their local aggressive growth rather than spreading to other parts of the body. The study focuses on using advanced imaging techniques to evaluate the changes in tumor components early during proton beam therapy, aiming to improve treatment decisions and outcomes. This is a prospective cohort study involving patients with these tumors who are treated at Leiden University Medical Center. Participants will undergo standard proton beam therapy for their tumor treatment. During the therapy, additional imaging assessments will be performed, including two extra MRI scans and one PET-CT scan. These functional imaging techniques will measure parameters such as tumor permeability and activity to detect changes within six months of starting treatment. The study will also compare imaging findings with surgical specimens in patients undergoing surgery after neo-adjuvant therapy to better understand tumor viability. Throughout the study, participants will have imaging and clinical evaluations at multiple time points: at inclusion, 4 and 8 weeks, and then at 5, 11, 17, and 23 months after starting proton therapy. Researchers will monitor functional MRI parameters and PET-CT measures, as well as clinical outcomes like survival, tumor progression, metastasis development, and treatment side effects. Data from imaging, treatment details, and clinical follow-up will be collected to assess how early imaging changes relate to patient outcomes. Participation involves minimal additional risk, as treatment and care remain standard.

Researchers are evaluating the clinical feasibility and effectiveness of an innovative online monitoring device called the INSIDE system during hadrontherapy treatments for certain cancers. The study focuses on patients treated at the Italian National Centre of Oncological Hadrontherapy with proton or carbon ion radiation for specific tumors such as meningioma, nasopharynx cancer, adenoid cystic carcinoma, and clival chordoma. The goal is to measure how well the INSIDE system can track the particle beam range inside the patient's body and ensure treatment matches the clinical plan, aiming to optimize the dose delivered while protecting healthy tissues. The INSIDE system combines two types of detectors: an in-beam Positron Emission Tomography (PET) scanner and a Dose Profiler, which collect signals generated during treatment without adding extra radiation to the patient. These detectors are placed around the patient immediately before treatment and remain in position during the irradiation. The system is compatible with multi-field irradiation and is used during the entire treatment period, which typically lasts about 4 to 6 weeks for the selected conditions. The study groups include patients receiving either carbon ion radiation therapy or proton radiation therapy. Participants undergo a longitudinal monitoring protocol where measurements are taken throughout the treatment to compare the ongoing therapy with the prescribed plan. Researchers will evaluate the stability of the INSIDE system's response, the clinical tolerances for particle range differences, and the potential benefits of integrating the system into routine clinical practice. The primary outcomes focus on particle range measurements averaged over five weeks and separately analyzed for each pathology over four months. The study's total duration and assessments support optimizing hadrontherapy treatment delivery and safety.

Researchers are studying the long-term cognitive and functional effects of two types of radiotherapy—proton therapy and conventional photon radiotherapy—in adults with cavernous sinus meningiomas. These tumors are located near critical structures such as the optic nerve and hippocampi, making radiation dose to these areas important due to potential late side effects like pituitary problems, nerve damage, and cognitive impairment. There is currently no prospective study comparing how these modern radiation methods affect brain function over time in these patients. Participants will receive either proton pencil-beam-scanning irradiation or intensity-modulated photon radiotherapy, both given in 28 fractions totaling 50.4 Gy. The study is randomized and open-label, comparing these two radiation approaches in patients aged 18 to 70 with specific types of meningioma. Treatment may be adjuvant or exclusive, and fractionation is standard. The trial is designed to assess if proton therapy's tissue-sparing benefits translate to reduced long-term toxicity. During the study, participants will undergo individual neurocognitive testing to monitor functional changes over five years. Researchers will also evaluate safety and long-term effects related to cognition and function. The total follow-up period allows careful observation of potential neurocognitive deterioration. Participants will provide informed consent and receive care according to protocol, with assessments including neuropsychological abilities and performance status to support study requirements.

Researchers are evaluating the feasibility of a combined treatment approach for patients with borderline resectable pancreatic cancer. This interventional, single-arm, open-label trial aims to test referral and enrollment procedures as well as the technical feasibility of delivering preoperative chemotherapy followed by proton therapy combined with chemotherapy and subsequent surgery when possible. The study is conducted due to the complexity of delivering high-dose proton therapy to large abdominal areas and the need for multidisciplinary care in pancreatic cancer patients. Participants will receive three cycles of chemotherapy with Nab-PACLitaxel and Gemcitabine, administered intravenously over 30 minutes on days 1, 8, and 15 of each cycle. This is followed by proton therapy delivered with a simultaneous integrated boost (SIB) alongside daily chemotherapy with capecitabine five days per week. Proton therapy doses range between 50.4 and 60.2 Gy relative biological effectiveness in 28 fractions. After completing this combined treatment, patients will be re-evaluated around week 21, and those meeting criteria will undergo surgery via laparotomy approximately during week 22. During the study, participants will be monitored for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) from enrollment until six months after surgery. Perioperative mortality and complications will be assessed up to 90 days post-surgery. Additional evaluations include tumor recurrence, progression-free and overall survival, pathologic tumor response, radiologic response, and quality of life assessments using specific questionnaires up to approximately five years after therapy. The study involves comprehensive medical tests, imaging, blood work, and quality of life questionnaires to track participant status and response to treatment over an extended follow-up period.

Researchers are evaluating a combination treatment including proton radiotherapy with the drugs tremelimumab and durvalumab for patients with unresectable hepatocellular carcinoma (HCC) at intermediate to advanced stages. This phase II trial aims to assess the safety, effectiveness, and immune effects of this combined approach since current therapies show limited response rates. Proton radiotherapy offers precise targeting with less damage to healthy tissue, and early data suggest that combining it with immune checkpoint inhibitors may improve tumor response. Participants will receive proton radiotherapy with doses adjusted based on tumor location and size: 72.6 CGE in 22 fractions for tumors close to vital organs and 66 CGE in 10 fractions for more distant tumors. Tremelimumab will be given as a single intravenous infusion of 300 mg, while durvalumab will be administered intravenously every 4 weeks at 1500 mg. Treatment duration with durvalumab depends on response, continuing up to two years for complete or partial responders and shorter for stable disease. During the study, participants will undergo regular clinical assessments including evaluation of progression-free survival over 12 months as the primary outcome. Other measures include tumor control, time to progression, overall response rate, survival, and monitoring of adverse events within one year. Patients will be monitored closely for safety and treatment effects throughout, with a total participation period aligned with these outcome assessments.