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Proctitis clinical trials

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NCT ID: NCT06087718 Not yet recruiting - Quality of Life Clinical Trials

Feasibility of the Maastro Applicator in Rectal Cancer

Start date: December 2023
Phase: N/A
Study type: Interventional

The goal of this interventional pilot trial is to confirm that Maastro endoluminal HDR ( High Dose Radiation) contact brachytherapy boosting is feasible and may increase the chance of functional organ sparing of the rectum in patients with rectal cancer. Participants will be treated with chemoradiotherapy and an endoluminal boost with the Maastro applicator.

NCT ID: NCT05489107 Recruiting - Radiation Proctitis Clinical Trials

New Local Treatment of Radiation-induced Proctitis

NOTRIP
Start date: July 1, 2022
Phase:
Study type: Observational

A prospective single-center observational study to evaluate the effectiveness of a local treatment with a mixture of hyaluronic acid, chondroitin sulfate and poloxamer 407 in patients with radiation-induced proctitis.

NCT ID: NCT05406882 Recruiting - Gut Microbiota Clinical Trials

The Effects of Probiotics Combined With Glutamine in the Prevention and Treatment of Radiation Proctitis

Start date: April 15, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Radiation proctitis is a common complication after radiation therapy for pelvic tumors. The investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical practice, but the mechanism is unknown. Through a prospective randomized controlled study, this study intends to investigate the incidence of grade 2 or higher acute radiation proctitis in patients of locally advanced rectal cancer after radiotherapy with the combined therapy. And through various scales, next-generation sequencing methods and other methods to evaluate the clinical symptoms, colonoscopy, imaging, and changes in the species and abundance of intestinal flora before and after treatment. To further explore the related pathways and mechanisms affecting radiation proctitis.

NCT ID: NCT04918992 Not yet recruiting - Pelvic Cancer Clinical Trials

Post Radiotherapy MRI Based AI System to Predict Radiation Proctitis for Pelvic Cancers

MRI-RP-2021
Start date: June 22, 2021
Phase:
Study type: Observational

In this study, investigators utilize a Artificial Intelligence (AI) supportive system to predict radiation proctitis for patients with pelvic cancers underwent radiotherapy. By the system, whether the participants achieve the radiation proctitis will be identified based on the radiomics features extracted from the post radiotherapy Magnetic Resonance Imaging (MRI) . The predictive power to discriminate the radiation proctitis individuals from non-radiation proctitis patients, will be validated in this multicenter, prospective clinical study.

NCT ID: NCT04680195 Not yet recruiting - Clinical trials for Chronic Radiation Proctitis

Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding

Thal-CRP
Start date: December 14, 2020
Phase: Phase 2
Study type: Interventional

Chronic radiation proctitis (CRP) is the main secondary toxic injury after pelvic radiotherapy. Hematochezia is the most common symptom for more than 80% of CRP patients. Non-surgical treatment is the first choice to the treatment of CRP to avoid the occurrence of serious complications. Conventional oral medication for the treatment of bleeding CRP is very few and has little effect. At present, no oral medication has been found to significantly alleviate and control refractory bleeding of CRP. Therefore, it is an urgent problem to screen out a drug that is more effective, safe and highly compliant for the treatment of hemorrhagic CRP. Thalidomide has anti-inflammatory, immune regulation, anti-angiogenesis and other effects. For the patients of CRP with intractable bleeding, a prospective, open clinical trial will be carried out to observe the safety and effectiveness of thalidomide in treating hemorrhagic CRP.

NCT ID: NCT04469686 Recruiting - Clinical trials for Ulcerative Proctitis

Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

Start date: December 10, 2020
Phase: Phase 3
Study type: Interventional

A randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of ulcerative colitis of the rectum.

NCT ID: NCT04335617 Recruiting - Proctitis Radiation Clinical Trials

Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis

MiFlaPRO
Start date: February 26, 2020
Phase: Phase 3
Study type: Interventional

national and multi-center trial for medical therapy of chronic radiation proctitis inducing anorectal bleedings

NCT ID: NCT03521232 Terminated - Ulcerative Colitis Clinical Trials

A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis

Start date: May 15, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This will be a phase I/IIa, open-label, three-stage, single center study aimed at investigating the safety, the efficacy (clinical and endoscopic effects) and the pharmacokinetics of Niclosamide enema 150 mg/60 ml and 450 mg/60 ml in subjects with mild-to-moderate UP and UPS, defined as a Modified Mayo Score (MMS) ≥ 4 and < 8, with a stool frequency subscore (SFS) ≥ 1, a rectal bleeding sub-score (RBS) = 1 or 2, and an endoscopic subscore (mucosal appearance) = 1 or 2. At the endoscopic sub-score any degree of friability will be classified as having a sub-scale score of 2.

NCT ID: NCT03397901 Recruiting - Anemia Clinical Trials

Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study

Start date: July 20, 2018
Phase: N/A
Study type: Interventional

Refractory rectal bleeding of chronic radiation proctitis (CRP) is still problematic and does not respond to medical treatments including reagents, endoscopic argon plasma coagulation (APC) or topical formalin. We proposed this prospective cohort study, to assess the efficacy and safety of colostomy in treating refractory hemorrhagic CRP with moderate to severe anemia, to provide higher-quality evidence of colostomy in these patients.

NCT ID: NCT03259659 Terminated - Clinical trials for Inflammatory Bowel Diseases

Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

Start date: November 30, 2017
Phase:
Study type: Observational [Patient Registry]

1. To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone. 2. To demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory cytokines. Presence of these abnormalities would make patients with ulcerative proctitis and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.