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Acute Radiation EnteritisPhase 2NCT07302126

Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy

A Phase 2 study testing Bergmann enema in people with Acute Radiation Enteritis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Research Objective and Principle: To evaluate the effectiveness of Bergmann enema in preventing acute radiation-induced rectal injury in patients with rectal cancer, thereby providing a basis for treatment options for potential radiation-induced rectal injury patients, aiming for adoption by international guidelines. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Radiation Enteritis
What is being tested?
Bergmann enema
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
11 Dec 2025to 11 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years, regardless of gender;
  • Fully understand this study and voluntarily sign the informed consent form, able to comply with the study protocol and complete all trial procedures;
  • Patients with pathologically confirmed mid-lower rectal cancer;
  • Undergoing short-course pelvic radiotherapy (total dose of 25-35Gy in 5.0-7.0 fractions over 5 consecutinve days);
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months;
  • Assessment by the attending physician and researcher indicates that vital organ function can tolerate the treatment risks.

Who cannot join

  • Severe comorbidities, including uncontrolled stable medical diseases after treatment, or a history of neurological or psychiatric disorders (such as dementia or epilepsy), making them unsuitable for radiotherapy;
  • Patients who have received pelvic radiotherapy;
  • Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;
  • Pregnant or breastfeeding women;
  • Patients expected to undergo major surgery during the study period;
  • Participation in other clinical trials within 4 weeks prior to enrollment;
Show all 10Show fewer
  • A history of alcohol abuse, drug use, or substance abuse within the past year;
  • Severe allergic constitution, or allergy to Bergmann;
  • Inability to cooperate with the enema;
  • Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jie Shi contact

+862085655905

shij36@mail.sysu.edu.cn

China1 site

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Lin Xiao Pang, +862085655905, pangxl48@mail.sysu.edu.cn

Other trials in China

About this study

Official title: Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy: a Prospective, Single-arm, Phase II Trial

Research Objective and Principle: To evaluate the effectiveness of Bergmann enema in preventing acute radiation-induced rectal injury in patients with rectal cancer, thereby providing a basis for treatment options for potential radiation-induced rectal injury patients, aiming for adoption by international guidelines.

Primary Objective: Incidence of grade 2 or higher radiation-induced rectal injury.

Read more

Secondary Objectives: Severity of radiation-induced rectal injury, completion rate of short-course radiotherapy, safety of Bergmann enema, quality of life, pathological complete response (pCR) rate.

Study Design: Prospective, single-center, single-arm study.

Study Population and Expected Enrollment: Patients with rectal cancer undergoing short-course radiotherapy, expecting to enroll 40 patients.

Trial Duration: From December 2025 to December 2026.

Intervention: Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.

Statistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 80%, and it is expected that Bergmann enema preventive treatment can reduce it to 50%. The sample size was estimated using a formula designed to calculate single-group rate, with a set at 0.05 and a power of 80%. The study aimed to enroll at least 36 patients. Considering a dropout rate of 10%, at least 40 patients need to be included.

Being tested
Bergmann enema
Keywords
Acute radiation-induced rectal injury, Rectal cancer, Short-course radiotherapy, Bergmann enema
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bergmann enemaDrug

    Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.

Study groups in NCT07302126
Study groupRoleWhat they receive
Experimental groupExperimentalPatients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.
Receives: Drug: Bergmann enema

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of grade 2 or higher radiation-induced rectal injury

    Measured: 3 months

Secondary outcomes (4)

  1. Severity of radiation-induced rectal injury

    Measured: 3 months

  2. Completion rate of short-course radiotherapy

    Measured: 9 months

  3. Safety of Bergmann enema

    Measured: 9 months

  4. Pathological complete response (pCR) rate

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start11 Dec 2025 (estimated)
  3. Primary completion11 Sep 2026 (estimated)
  4. Study completion11 Dec 2026 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Intervention: Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07302126
Sponsor's protocol ID
Berg-ARRI-SCRT
Status last verified
Dec 2025
First submitted
11 Dec 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kennedy M, Bruninga K, Mutlu EA, Losurdo J, Choudhary S, Keshavarzian A. Successful and sustained treatment of chronic radiation proctitis with antioxidant vitamins E and C. Am J Gastroenterol. 2001 Apr;96(4):1080-4. doi: 10.1111/j.1572-0241.2001.03742.x.

    PubMed 11316150

  • Ehrenpreis ED, Jani A, Levitsky J, Ahn J, Hong J. A prospective, randomized, double-blind, placebo-controlled trial of retinol palmitate (vitamin A) for symptomatic chronic radiation proctopathy. Dis Colon Rectum. 2005 Jan;48(1):1-8. doi: 10.1007/s10350-004-0821-7.

    PubMed 15690650

  • 王楠, 丁田贵与尹立杰, 医用射线防护喷剂防治放射性口腔黏膜炎的临床观察. 口腔医学, 2020. 40(08): 第728-730+737页.

  • 李祎萍, 医用射线防护喷剂应用在乳腺癌患者急性放射性皮肤损伤中的效果. 实用临床护理学电子杂志, 2016. 1(12): 第167+169页.

  • 张力元等, 医用射线防护喷剂防治皮肤黏膜放射性损伤的临床观察. 中华放射医学与防护杂志, 2006(06): 第597-599页.

  • 张慧, 章真与袁双虎, 放射性直肠损伤的预防与治疗临床实践指南. 中华肿瘤防治杂志, 2023. 30(5): 第245-259页.

  • 中华医学会外科学分会结直肠外科学组, 中国医师协会外科医师分会结直肠外科医师委员会与中国抗癌协会大肠癌专业委员会, 中国放射性直肠损伤多学科诊治专家共识（2021版）. 中华胃肠外科杂志, 2021. 24(11): 第937-949页.

  • 中国医师协会外科医师分会与中华医学会外科学分会结直肠外科学组, 中国放射性直肠炎诊治专家共识(2018版). 中华胃肠外科杂志, 2018. 21(12): 第1321-1336页.

  • Paquette IM, Vogel JD, Abbas MA, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of The American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Treatment of Chronic Radiation Proctitis. Dis Colon Rectum. 2018 Oct;61(10):1135-1140. doi: 10.1097/DCR.0000000000001209. No abstract available.

    PubMed 30192320

  • Jahraus CD, Bettenhausen D, Malik U, Sellitti M, St Clair WH. Prevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1483-7. doi: 10.1016/j.ijrobp.2005.04.032. Epub 2005 Aug 15.

    PubMed 16099600

  • Gami B, Harrington K, Blake P, Dearnaley D, Tait D, Davies J, Norman AR, Andreyev HJ. How patients manage gastrointestinal symptoms after pelvic radiotherapy. Aliment Pharmacol Ther. 2003 Nov 15;18(10):987-94. doi: 10.1046/j.1365-2036.2003.01760.x.

    PubMed 14616164

  • Qin Q, Huang B, Cao W, Zhou J, Ma T, Zhou Z, Wang J, Wang L. Bowel Dysfunction After Low Anterior Resection With Neoadjuvant Chemoradiotherapy or Chemotherapy Alone for Rectal Cancer: A Cross-Sectional Study from China. Dis Colon Rectum. 2017 Jul;60(7):697-705. doi: 10.1097/DCR.0000000000000801.

    PubMed 28594719

  • Qin Q, Ma T, Deng Y, Zheng J, Zhou Z, Wang H, Wang L, Wang J. Impact of Preoperative Radiotherapy on Anastomotic Leakage and Stenosis After Rectal Cancer Resection: Post Hoc Analysis of a Randomized Controlled Trial. Dis Colon Rectum. 2016 Oct;59(10):934-42. doi: 10.1097/DCR.0000000000000665.

    PubMed 27602924

  • Haddock MG, Sloan JA, Bollinger JW, Soori G, Steen PD, Martenson JA; North Central Cancer Treatment Group. Patient assessment of bowel function during and after pelvic radiotherapy: results of a prospective phase III North Central Cancer Treatment Group clinical trial. J Clin Oncol. 2007 Apr 1;25(10):1255-9. doi: 10.1200/JCO.2006.09.0001.

    PubMed 17401014

  • Andreyev J. Gastrointestinal symptoms after pelvic radiotherapy: a new understanding to improve management of symptomatic patients. Lancet Oncol. 2007 Nov;8(11):1007-17. doi: 10.1016/S1470-2045(07)70341-8.

    PubMed 17976611

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bergmann enema in people with Acute Radiation Enteritis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Dec 2025. 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 China. 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.

What does this phase mean?

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jie Shi (+862085655905, shij36@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of grade 2 or higher radiation-induced rectal injury (time frame: 3 months). 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 NCT07302126, which also lists 20 linked publications.

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 24 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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