NCT04819685

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 17, 2021

Last Update Submit

March 26, 2021

Conditions

Cervical CancerRadiotherapy Side EffectRadiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

  • Degree of rectal mucosal injury caused by acute radiation

    the incidence of Vienna rectoscopy score ≥2 within 1 week after radiotherapy. Vienna rectoscopy score was used.

    Within 1 week after radiotherapy

Secondary Outcomes (4)

  • Degree of rectal injury caused by chronic radiation

    3 to 24 months after radiotherapy

  • Quality of life score

    3 to 24 months after radiotherapy

  • overall survival (OS)

    3 years after radiotherapy

  • disease-progression-free survival (PFS)

    3 years after radiotherapy

Study Arms (2)

test group

EXPERIMENTAL

Intervention:Anti-radiation spray (liquid dressing)

Drug: KANG FU PEN

control group

NO INTERVENTION

Interventions

KANG FU PENDRUG

FU PEN: anti-radiation spray (liquid dressing) treatment which is a protective irrigation solution against rays

test group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is completely voluntary and has the ability to sign the research informed consent form within 30 days before enrollment;
  • Age ≥18 years old and ≤65 years old;
  • Pathologically confirmed cervical cancer;
  • Those with IB3, IIA2, IIB, IIIA, IIIB, and those with cervical tumor ≥ 4cm or involved parametrial in IIIC1 and IIIC2 (FIGO 2018 staging);
  • ECOG score 0-2 points;
  • 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;
  • Those who have had regular bowel movements and had a negative stool routine test + occult blood before enrollment.

You may not qualify if:

  • Those who have a history of allergy to superoxide dismutase use;
  • Patients with skin and mucous membrane infections, patients with obvious empyema or pelvic inflammatory disease;
  • Those who have had chronic colitis, ulcerative colitis, and non-specific proctitis in the past;
  • Those who have received cervical cancer surgery (including pelvic or retroperitoneal lymphadenectomy, excluding tumor biopsy), radiotherapy or chemotherapy;
  • 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;
  • Those who need to use fluorouracil or capecitabine or tigio in the concurrent chemotherapy regimen;
  • History of other malignant tumors;
  • Pregnant or lactating women;
  • Accompanied by active infection and fever;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesWounds and Injuries

Central Study Contacts

Fuquan Zhang, MD

CONTACT

+86 010 6915 5485zhangfuquan3@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 29, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2025

Last Updated

March 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)