Radiation ProctitisNOTRIPNCT05489107
New Local Treatment of Radiation-induced Proctitis
An observational study of Radiation Proctitis, run by Barmherzige Brüder Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Radiation Proctitis
- What is being tested?
- Ziverel
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- lack of informed consent;
- non-adherence to study protocol;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Krankenhaus der Barmherzigen Brüder
Vienna, 1020
Iliyan Iliev, MD, 0043 1 21121 ext. 5285, iliyaniliev18s@gmail.com
About this study
Official title: 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.
- Conditions
- Radiation Proctitis
- Being tested
- Ziverel
- Keywords
- radiation, proctitis, hyaluronic acid, chondroitin sulfate, poloxamer 407, local treatment, rectoscopy
- Medical subject headings
- Proctitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiverelOther
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Jul 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ProctitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barmherzige Brüder Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILIYAN ILIEV, Barmherzige Brüder Vienna
- Investigators
- Bernhard Dauser, Assoc. Prof., Study chair, Krankenhaus der Barmherzige Brüder Wien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489107
- Sponsor's protocol ID
- 202207-01
- Acronym
- NOTRIP
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Option for the Treatment of Radiation-induced Proctitis Study
- ClinicalTrials.gov ID
- NCT05489107
- Acronym / sponsor ID
- NOTRIP / 202207-01
- Conditions
- Radiation Proctitis
- Keywords
- radiation, proctitis, hyaluronic acid, chondroitin sulfate, poloxamer 407, local treatment, rectoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Barmherzige Brüder ViennaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- lack of informed consent;
- non-adherence to study protocol;
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZiverelWithin 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. | Other | – |
Primary outcome
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 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Radiation Proctitis
RecruitingPhase 2
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Radiation Induced Proctitis
RecruitingObservational study
Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
Pelvic Toxicity, Radiation Toxicity
Not yet recruitingPhase 3
A Study of Chlorophyllin or Placebo With Standard Treatment for Late Radiation Induced Luminal Gastrointestinal Tract Bleeding
Radiation Proctitis, Gastrointestinal Hemorrhage
RecruitingObservational study
Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy
Radiotherapy, Radiation Proctitis
RecruitingPhase 2
Dietary Supplements to Treat Radiation-Induced Rectal Injury
Radiotherapy, Radiation Proctitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Dauser, Assoc. Prof. study chair
Krankenhaus der Barmherzige Brüder Wien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Proctitis, run by Barmherzige Brüder Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iliyan Iliev, MD (0043 1 21121 ext. 5285, iliyaniliev18s@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Petechiae in the most affected areas of the rectal mucosa. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.