Chronic Radiation ProctitisPhase 4NCT01613534
Combined Therapy in Radiation Proctopathy
A Phase 4 study testing Sucralfate in people with Chronic Radiation Proctitis, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
The aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Radiation Proctitis
- What is being tested?
- Sucralfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2003to Jun 2007
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- radiotherapy due to pelvic tumors completed at least three months prior to enrollment
- presence of rectal bleeding
- radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy
- informed written consent to participate in the study
Who cannot join
- history of clinically significant rectal bleeding prior to radiotherapy
- conditions predisposing the patient to rectal bleeding including inflammatory bowel disease, tumors of the large bowel, intestinal vascular lesions (other than radiation-induced telangiectasia), and diversion of the fecal stream
- sucralfate treatment during the two weeks prior to enrollment
- renal insufficiency (creatinine level ≥2 mg/dl)
- concurrent chemotherapy
- concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because of drug interaction)
- concurrent therapy with oral anticoagulants
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and Department of Gastroenterology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Masovian Voivodeship, 02-781
About this study
Official title: Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial
The aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy.
Read the detailed description
Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are difficult to treat and adversely impact patient quality of life. Various treatments directed at the reduction of blood loss and improvement of other symptoms have been evaluated, with the most encouraging results reported for two methods: endoscopic argon plasma coagulation (APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of sucralfate, a drug believed to enhance the mucosal defense and healing when administered orally or rectally. Adequately powered randomized trials comparing various treatments are lacking, and an optimal management strategy has yet to be determined. To address this issue, we conducted a single-center, randomized, placebo-controlled, double-blind study comparing the efficacy and safety of APC alone and APC in combination with sucralfate administered orally.
- Conditions
- Chronic Radiation Proctitis
- Being tested
- Sucralfate, Placebo
- Keywords
- chronic radiation proctopathy, argon plasma coagulation, sucralfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucralfateDrug
Also called Carafate, Ulgastran
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks
PlaceboDrug
Argon plasma coagulation treatment followed by placebo administration for four weeks
| Study group | Role | What they receive |
|---|---|---|
| APC plus oral sucralfate | Experimental | Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks. Receives: Drug: Sucralfate |
| APC plus placebo | Placebo comparator | Argon plasma coagulation treatment followed by placebo administration for four weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in disease severity scores, as assessed using our three-item symptom scale
Three-item symptom scale Diarrhea - score 1: 1-3 stools/24 h; 2: 4-6 stools/24 h; 3 >6 stools/24 h Bleeding - score 0: No blood; 1: Blood on toilet paper or stool; 2: Blood in toilet bowl; 3: Heavy bleeding with clots; 4: Bleeding requiring transfusions Tenesmus/rectal pain - score 0: Absent; 1: Mild tenesmus not requiring any drug; 2: Tenesmus requiring analgesics/antispasmodics; 3: Severe tenesmus requiring everyday use of analgetics/antispasmodics.
Measured: baseline vs. 16 week
Secondary outcomes (3)
change in endoscopic severity score
Endoscopic severity score of chronic radiation proctopathy:
Normal, score 0 - Normal mucosa Mild, score 3 - Erythema and/or teleangiectasia, edema, thickening, pallor of mucosa Moderate, score 6 - Above plus friability Severe, score 9 - Ulceration and/or necrosis
Measured: baseline vs. week 8 and week 16
change in disease severity score
disease severity score as in primary outcome measure
Measured: baseline vs. week 52
complication rate
Measured: baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJun 2003
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Centre for Postgraduate Education
- Responsible party
- Sponsor
- Investigators
- Magdalena R Chruscielewska-Kiliszek, MD, PhD, Principal investigator, Medical Centre for Postgraduate Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613534
- Sponsor's protocol ID
- 501-2-1-09-14/03
- Status last verified
- Jun 2012
- First submitted
- 5 Jun 2012
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chruscielewska-Kiliszek MR, Regula J, Polkowski M, Rupinski M, Kraszewska E, Pachlewski J, Czaczkowska-Kurek E, Butruk E. Sucralfate or placebo following argon plasma coagulation for chronic radiation proctitis: a randomized double blind trial. Colorectal Dis. 2013 Jan;15(1):e48-55. doi: 10.1111/codi.12035.
PubMed 23006660
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01613534
- Acronym / sponsor ID
- 501-2-1-09-14/03
- Conditions
- Chronic Radiation Proctitis
- Keywords
- chronic radiation proctopathy, argon plasma coagulation, sucralfate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Medical Centre for Postgraduate Education
- Study start
- Jun 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 7 Jun 2012 (estimated)
- 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.
The aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy.
Detailed description
Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are difficult to treat and adversely impact patient quality of life. Various treatments directed at the reduction of blood loss and improvement of other symptoms have been evaluated, with the most encouraging results reported for two methods: endoscopic argon plasma coagulation (APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of sucralfate, a drug believed to enhance the mucosal defense and healing when administered orally or rectally. Adequately powered randomized trials comparing various treatments are lacking, and an optimal management strategy has yet to be determined. To address this issue, we conducted a single-center, randomized, placebo-controlled, double-blind study comparing the efficacy and safety of APC alone and APC in combination with sucralfate administered orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APC plus oral sucralfate | Experimental | Drug: SucralfateArgon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks. |
| APC plus placebo | Placebo comparator | Drug: PlaceboArgon plasma coagulation treatment followed by placebo administration for four weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- radiotherapy due to pelvic tumors completed at least three months prior to enrollment
- presence of rectal bleeding
- radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy
- informed written consent to participate in the study
Key exclusion criteria (7 listed)
- history of clinically significant rectal bleeding prior to radiotherapy
- conditions predisposing the patient to rectal bleeding including inflammatory bowel disease, tumors of the large bowel, intestinal vascular lesions (other than radiation-induced telangiectasia), and diversion of the fecal stream
- sucralfate treatment during the two weeks prior to enrollment
- renal insufficiency (creatinine level ≥2 mg/dl)
- concurrent chemotherapy
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 |
|---|---|---|
| SucralfateAlso: Carafate, UlgastranArgon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks | Drug | APC plus oral sucralfate |
| PlaceboArgon plasma coagulation treatment followed by placebo administration for four weeks | Drug | APC plus placebo |
Primary outcome
change in disease severity scores, as assessed using our three-item symptom scale
Time frame: baseline vs. 16 week
Three-item symptom scale Diarrhea - score 1: 1-3 stools/24 h; 2: 4-6 stools/24 h; 3 >6 stools/24 h Bleeding - score 0: No blood; 1: Blood on toilet paper or stool; 2: Blood in toilet bowl; 3: Heavy bleeding with clots; 4: Bleeding requiring transfusions Tenesmus/rectal pain - score 0: Absent; 1: Mild tenesmus not requiring any drug; 2: Tenesmus requiring analgesics/antispasmodics; 3: Severe tenesmus requiring everyday use of analgetics/antispasmodics.
3 secondary outcomes
change in endoscopic severity score
Time frame: baseline vs. week 8 and week 16
change in disease severity score
Time frame: baseline vs. week 52
complication rate
Time frame: baseline to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- Derived from this study: PubMed 23006660Chruscielewska-Kiliszek MR, Regula J, Polkowski M, Rupinski M, Kraszewska E, Pachlewski J, Czaczkowska-Kurek E, Butruk E. Sucralfate or placebo following argon plasma coagulation for chronic radiation proctitis: a randomized double blind trial. Colorectal Dis. 2013 Jan;15(1):e48-55. doi: 10.1111/codi.12035.
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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.
Magdalena R Chruscielewska-Kiliszek, MD, PhD principal investigator
Medical Centre for Postgraduate Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sucralfate in people with Chronic Radiation Proctitis, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 7 Jun 2012. 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 Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in disease severity scores, as assessed using our three-item symptom scale (time frame: baseline vs. 16 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01613534, which also lists 1 linked publication.
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 7 Jun 2012.