The Role of Hyaluronic Acid in Preventing Rectal Complications in Prostate Cancer Patients Undergoing Radiotherapy

investigation of the Role of Hyaluronic Acid Suppositories in Preventing Rectal Complications in Patients with Prostate Carcinoma Undergoing Radiotherapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241210064017N1

Enrollment

Registered

2025-03-16

Start date

2022-08-23

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer.radiation therapy. Malignant neoplasm of prostate

Interventions

Intervention 1: Intervention group: They are treated with topical rectal hyaluronic acid in the form of a suppository containing 5 mg of hyaluronic acid. Intervention 2: Control group: No intervention

Eligibility

Sex/Gender

Male

Age

35 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients with prostate carcinoma who are candidates for definitive treatment with radiotherapy Absence of inflammatory bowel disease and diabetes No history of prior pelvic radiotherapy and absence of anal diseases(hemorrhoids, fissures, and fistulas).

Exclusion criteria

Exclusion criteria: Presence of inflammatory bowel disease and diabetes Concurrent treatment with oral or injectable corticosteroids History of prior pelvic radiotherapy Presence of analdiseases (hemorrhoids, fissures, and fistulas). History of prostate surgery

Design outcomes

Primary

Measure	Time frame
Rectal Complications by Grade. Timepoint: Rectal complications caused by radiotherapy were monitored weekly during the treatment period and then monthly for up to three months after the completion of treatment. Method of measurement: Information regarding rectal complications caused by radiotherapy in patients is collected weekly during treatment and after the completion of radiotherapy through in-person or telephone interviews conducted by the researcher.	—

Measure

Time frame

Rectal Complications by Grade. Timepoint: Rectal complications caused by radiotherapy were monitored weekly during the treatment period and then monthly for up to three months after the completion of treatment. Method of measurement: Information regarding rectal complications caused by radiotherapy in patients is collected weekly during treatment and after the completion of radiotherapy through in-person or telephone interviews conducted by the researcher.

—

Secondary

Measure	Time frame
Prevention of rectal complications. Timepoint: Rectal complications caused by radiotherapy were monitored weekly during the treatment period and then monthly for up to three months after the completion of treatment. Method of measurement: information regarding rectal complications caused by radiotherapy in patients is collected weekly during treatment and after the completion of radiotherapy through in-person or telephone interviews conducted by the researcher.	—

Measure

Time frame

Prevention of rectal complications. Timepoint: Rectal complications caused by radiotherapy were monitored weekly during the treatment period and then monthly for up to three months after the completion of treatment. Method of measurement: information regarding rectal complications caused by radiotherapy in patients is collected weekly during treatment and after the completion of radiotherapy through in-person or telephone interviews conducted by the researcher.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSahar Dashti

Iran University of Medical Sciences

sahardashti1992@gmail.com+98 21 86701

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026