New Local Treatment of Radiation-induced Proctitis (NOTRIP)

August 3, 2022 updated by: ILIYAN ILIEV, Barmherzige Brüder Vienna

New Option for the Treatment of Radiation-induced Proctitis Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1020
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients between 18 and 99 years of age with radiation proctitis under/after prior radiation therapy beacuse of oncological conditions in the pelvic area.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
Time Frame: 1 month
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)
Time Frame: 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barmherzige Brüder Vienna

Investigators

  • Study Chair: Bernhard Dauser, Assoc. Prof., Krankenhaus der Barmherzige Brüder Wien

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202207-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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