Effects of Different Radiation Dosimetry for Anorectal Function of Patients With Pelvic Cancer: a Study Protocol for a Prospective, Observational, Controlled, Multicenter Study

Status: Not_yet_recruiting
Intervention Type: Radiation
Study Type: Observational
SUMMARY

In this prospective, open, multicenter, multi-arm, observational controlled study, the investigators investigated the impact of different pelvic radiation doses of anal cancer and rectal cancer patients on the dynamic changes of anal function, and analyzed the correlation between the changes of anal function and the score of anal incontinence in the radiation dose≤50Gy group and \>50Gy group. The study population includes 124 patients with anal canal cancer or rectal cancer who have received sphincter preservation treatments (including radiochemotherapy), aged from 18 to 75 years old undergoing sphincter preservation treatments at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University. The primary outcome is the average resting pressure of anal sphincter. The secondary outcomes are maximum anal sphincter contraction pressure and Wexner continence score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5……). Follow-up for each patient will be at least 2 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Recently (less than 4 weeks) received surgery or patients with recent severe trauma.

• Significant cardiac disease: congestive heart failure of New York Heart Association class ≥2; patients with recent (less than 12 months) active coronary artery disease (unstable angina or myocardial infarction).

• Recent (less than 6 months) thrombosis or embolism events, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism and deep vein thrombosis.

• Patients with toxicity (Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2) caused by previous treatment that has not subsided.

• Women who suffered anal sphincter tear after vaginal delivery. Pregnant or lactating women.

Time Frame
Start Date: 2023-05-15
Completion Date: 2026-05-30
Participants
Target number of participants: 124
Treatments
radiation dose≤50Gy
rectal cancer with IMRT radiation dose≤50Gy
radiation dose>50Gy
anal cancer with IMRT radiation dose\>50Gy
Related Therapeutic Areas
Sponsors
Leads: Sixth Affiliated Hospital, Sun Yat-sen University

This content was sourced from clinicaltrials.gov