CompletedNot Applicable

Adjunctive Treatments for the Prevention of Radiotherapy-Induced Mucositis

Egypt60 participantsStarted 2024-01-01

Plain-language summary

Radiation therapy (RT) is used in at least 50% of cancer patients and is critical in treating and palliating tumor-related symptoms. Normal tissue radiation toxicity remains an overwhelming obstacle in treating cancer patients with localized tumors. Mucositis is the inflammation and ulceration of the oral and gastrointestinal mucosa observed with different cancer therapies. Oral mucositis is a common, severe, and debilitating complication of RT occurring several days to weeks after RT initiation.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adults (\>18 years) with histopathologically confirmed Head and Neck Cancer (HNC), primary tumor in the stages T1, T2, T3, or T4, a regional node of any N status, and distant metastases absent.
✓. All patients who were going to receive RT (dose between 60-70 Gy) on the head and neck region as postoperative (adjuvant) or definitive therapy. Either these patients had received chemotherapy prior or in concomitant to radiotherapy.
✓. Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2 and normal hematologic and biochemical parameters.

Exclusion criteria

✕. patients undergoing previous radiotherapy
✕. uncontrolled systemic or widely disseminated disease
✕. having any physical or mental abnormality,
✕. pregnant and lactating women
✕. presence of a synchronous double primary malignancy or simultaneous participation in another clinical trial

What they're measuring

Oral mucositis Severity

Timeframe: 7 weeks

Trial details

NCT IDNCT06117904

SponsorBeni-Suef University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

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