Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Radiation Proctitis Acute Radiation Enteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

Hyaluronic Acid

Intervention Type DRUG

Hyaluronic Acid to be used as sodium hyaluronate powder plus inactive ingredient (Carboxy methyl cellulose) and to be dissolved in distilled water

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water

Interventions

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Hyaluronic Acid

Hyaluronic Acid to be used as sodium hyaluronate powder plus inactive ingredient (Carboxy methyl cellulose) and to be dissolved in distilled water

Intervention Type DRUG

Placebo

Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water

Intervention Type OTHER

Other Intervention Names

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Sodium Hyaluronate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No