Acute Radiation ProctitisPhase 1/2NCT06469216
Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis
A Phase 1/2 study testing Hyaluronic Acid in people with Acute Radiation Proctitis and Acute Radiation Enteritis, run by Assiut University at 2 sites in Egypt.
Trial summary
A randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Radiation Proctitis, Acute Radiation Enteritis
- What is being tested?
- Hyaluronic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Apr 2024to 1 Dec 2024
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients diagnosed with pelvic or gastrointestinal malignancies (tumors in uterus, cervix, prostate, seminal vesicles, kidney, colon, etc.),
- All patients who required adjuvant or radical radiation therapy;
- Age \< 80 years;
- Karnofsky Performance Status ≥ 60
Who cannot join
- Patients were excluded if they had
- gt; previous pelvic radiotherapy,
- gt; inflammatory bowel disease or
- gt; rectal issues (e.g., haemorrhoids).
- Patients diagnosed with cancer rectum
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ahmed Maher teaching hospitals
Cairo, Cairo Governorate, 055
Al-Ahrar teaching hospital
Zagazig, Sharqia Province, 055
About this study
Official title: Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis: Multi-center, Double-blind, Randomized Controlled Trial
A randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy.
- Being tested
- Hyaluronic Acid, Placebo
- Keywords
- double blind, placebo control, Randomized Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
Also called Sodium Hyaluronate
Hyaluronic Acid to be used as sodium hyaluronate powder plus inactive ingredient (Carboxy methyl cellulose) and to be dissolved in distilled water
PlaceboOther
Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water
| Study group | Role | What they receive |
|---|---|---|
| 30 ml of Hyaluronic Acid (HA) enema will be given to the patients | Active comparator | All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest. Receives: Drug: Hyaluronic Acid |
| 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients | Placebo comparator | All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (in days) to occurrence of Acute Radiation Proctitis
Measured: for each patient: time from the first day of radiation therapy for up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Apr 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Radiation ProctitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Gamal El Sheikh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469216
- Sponsor's protocol ID
- 05-2023-018
- Status last verified
- Jan 2025
- First submitted
- 17 Jun 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis: Multi-center, Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06469216
- Acronym / sponsor ID
- 05-2023-018
- Keywords
- double blind, placebo control, Randomized Clinical Trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 21 Jun 2024 (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 randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 ml of Hyaluronic Acid (HA) enema will be given to the patients | Active comparator | Drug: Hyaluronic AcidAll patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest. |
| 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients | Placebo comparator | Other: PlaceboAll patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients diagnosed with pelvic or gastrointestinal malignancies (tumors in uterus, cervix, prostate, seminal vesicles, kidney, colon, etc.),
- All patients who required adjuvant or radical radiation therapy;
- Age \< 80 years;
- Karnofsky Performance Status ≥ 60
Key exclusion criteria (5 listed)
- Patients were excluded if they had
- Patients diagnosed with cancer rectum
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 |
|---|---|---|
| Hyaluronic AcidAlso: Sodium HyaluronateHyaluronic Acid to be used as sodium hyaluronate powder plus inactive ingredient (Carboxy methyl cellulose) and to be dissolved in distilled water | Drug | 30 ml of Hyaluronic Acid (HA) enema will be given to the patients |
| PlaceboInactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water | Other | 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients |
Primary outcome
Time (in days) to occurrence of Acute Radiation Proctitis
Time frame: for each patient: time from the first day of radiation therapy for up to 3 months
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 22 Jan 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyaluronic Acid in people with Acute Radiation Proctitis and Acute Radiation Enteritis, run by Assiut University at 2 sites in Egypt.
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 5 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time (in days) to occurrence of Acute Radiation Proctitis (time frame: for each patient: time from the first day of radiation therapy for up to 3 months). 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 22 Jan 2025.