Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis

Assiut University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Radiation Proctitis; Acute Radiation Enteritis

Treatments: Other: Placebo; Drug: Hyaluronic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06469216

05-2023-018

Details and patient eligibility

About

A randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy.

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients diagnosed with pelvic or gastrointestinal malignancies (tumors in uterus, cervix, prostate, seminal vesicles, kidney, colon, etc.),
• All patients who required adjuvant or radical radiation therapy;
• Age < 80 years;
• Karnofsky Performance Status ≥ 60

Exclusion criteria

• Patients were excluded if they had

  • gt; previous pelvic radiotherapy,
  • gt; inflammatory bowel disease or
  • gt; rectal issues (e.g., haemorrhoids).

• Patients diagnosed with cancer rectum

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

30 ml of Hyaluronic Acid (HA) enema will be given to the patients

Active Comparator group

Description:

All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest.

Treatment:

Drug: Hyaluronic Acid

30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients

Placebo Comparator group

Description:

All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest.

Treatment:

Other: Placebo