Clinical trial · Interventional
Application of KANG FU PEN in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury
Application of KANG FU PEN (Protective Irrigation Solution Against Rays) in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury:a Multicenter, Prospective, Randomized Trail
NCT04819685CI-TRIAL-00050917unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A total of 520 cases will be randomly divided into Kang Fu Pen (liquid dressing) enema intervention group (experimental group) and non-enema intervention group (control group), according to the ratio of 1:1.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy; Complications | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KANG FU PEN | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- test group
- description
- Intervention:Anti-radiation spray (liquid dressing)
- interventionNames
- Drug: KANG FU PEN
- type
- NO_INTERVENTION
- label
- control group
Primary outcomes (1)
- measure
- Degree of rectal mucosal injury caused by acute radiation
- timeFrame
- Within 1 week after radiotherapy
- description
- the incidence of Vienna rectoscopy score ≥2 within 1 week after radiotherapy. Vienna rectoscopy score was used.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient is completely voluntary and has the ability to sign the research informed consent form within 30 days before enrollment; 2. Age ≥18 years old and ≤65 years old; 3. Pathologically confirmed cervical cancer; 4. Those with IB3, IIA2, IIB, IIIA, IIIB, and those with cervical tumor ≥ 4cm or involved parametrial in IIIC1 and IIIC2 (FIGO 2018 staging); 5. ECOG score 0-2 points; 6. The complete blood count and basal metabolic indexes in the 14 days before enrollment must meet the following requirements: NEUT≥1.5\*10\^9/L, HGB≥80g/L, PLT≥100\*10\^9/L, blood creatinine \< 1.5mg/dl (133umol/L), AST and ALT are within 2 times of the upper limit of normal; 7. Those who have had regular bowel movements and had a negative stool routine test + occult blood before enrollment. Exclusion Criteria: 1. Those who have a history of allergy to superoxide dismutase use; 2. Patients with skin and mucous membrane infections, patients with obvious empyema or pelvic inflammatory disease; 3. Those who have had chronic colitis, ulcerative colitis, and non-specific proctitis in the past; 4. Those who have received cervical cancer surgery (including pelvic or retroperitoneal lymphadenectomy, excluding tumor biopsy), radiotherapy or chemotherapy; 5. Those who are expected to be unable to receive brachytherapy, or brachytherapy needs to use tumor elimination, uterine tube inserted alone in one fraction, or template plan; 6. Those who need to use fluorouracil or capecitabine or tigio in the concurrent chemotherapy regimen; 7. History of other malignant tumors; 8. Pregnant or lactating women; 9. Accompanied by active infection and fever; 10. Other serious diseases that may significantly affect the compliance of clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment.
References
Publications (1)
- DERIVEDZhu J, Li X, Huang M, Zhu H, Tan Y, He X, Sun Z, Cheng H, Li F, Jiang P, Lou H, Ke G, Cao X, Zhu L, Xie P, Yan J, Zhang F. Application of Recombinant Human Superoxide Dismutase in Radical Concurrent Chemoradiotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Acute Rectal Injury: A Multicenter, Randomized, Open-label, Prospective Trial. Int J Radiat Oncol Biol Phys. 2024 Nov 1;120(3):720-729. doi: 10.1016/j.ijrobp.2024.04.070. Epub 2024 May 4. PMID 38705489