New Local Treatment of Radiation-induced Proctitis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
New Option for the Treatment of Radiation-induced Proctitis Study

Conditions
-----------------
Radiation Proctitis

Intervention / Treatment
-----------------
* Other: Ziverel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven symptomatic acute or chronic radiation-induced proctitis; current or prior radiation therapy in the pelvic area; patients with complications connected to the radiation therapy. Exclusion Criteria: lack of informed consent; non-adherence to study protocol; pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ziverel|Within a first flexible rectoscopy (Day 1) the product will be applied transanally. Then the patients will apply it as enemas twice daily for 7 days. On day 8 (after treatment completion), and on day 31 (after 23 days of no treatment) follow-up flexible rectoscopies will be performed.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Petechiae in the most affected areas of the rectal mucosa. | Assessment of the effects of the mixture on the number of petechiae in the rectum. Within the first flexible rectoscopy (Day 1) the most affected areas of the rectal mucosa (on the anterior and posterior wall) will be determined. A 27 mm CAPTIVATOR hexagonal polypectomy snare (Boston Scientific) will be introduced through the endoscope, and will be fully opened. The fully open polypectomy snare (9,2 cm2) will be applied over the most affected areas on the anterior and posterior rectal wall, and the number of the petechiae within these areas will be documented. The flexible rectoscopy will be repeated on day 8 after patients have already received enemas with the examined substance twice daily for one week, and the number of the petechiae will be documented as above mentioned. After a period of 23 days with no treatment, a follow-up flexible rectoscopy will be performed on day 31, and the petechiae of the rectal mucosa will be once more assessed. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patients' quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Proctitis Module with 20 Questions (EORTC QLQ-PRT20) | The effects of the mixture on subjects' quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Proctitis Module with 20 Questions Score (EORTC QLQ-PRT20). The questionnaire consists of 18 quantitative, 2 qualitative (one of them being optional), and 1 semi-quantitative questions . Using the quantitative questions, a score can be defined. Its minimum value is 18 (meaning patients have no symptoms), and its maximum value is 72 (meaning greatest extent of lifestyle limitations because of radiation proctitis). The semi-quantitative question provides information about the highest number of defecations per 24 hours and is not included in the score. The qualitative questions determine the use of medicines, and patients' will to receive any assistance concerning their symptoms. The score will be documented on day 1, 8, 31 and 6 months after treatment completion. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation, proctitis, hyaluronic acid, chondroitin sulfate, poloxamer 407, local treatment, rectoscopy