Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis

Mansoura University

Status and phase: Completed; Phase 2

Conditions: Radiation-Induced Mucositis

Treatments: Drug: N-acetyl cysteine; Drug: saline mouth wash; Drug: Zinc sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT06482034

M02040230M

Details and patient eligibility

About

The majority of individuals diagnosed with head and neck cancer, who undergo radiotherapy or concurrent Chemoradiotherapy, experience oral mucositis. Our research focuses on investigating the preventive and therapeutic impact of N-acetylcysteine and zinc in managing radiotherapy-induced oral mucositis.

Full description

almost all head and neck cancer patients who to receive radiotherapy or concurrent chemotherapy suffer from oral mucositis. Oral mucositis (OM) is associated with pain, difficulty in eating, dysphagia, and the need for enteral or parenteral nutrition, increased opioid consumption or even interruptions to cancer therapy. In immunosuppressed patients, OM is associated with bacteremia, increased inpatient hospitalization duration and higher 100-day mortality.

Treatments to manage cancer, such as radiotherapy, generates reactive oxygen species (ROS) that target neoplastic cell DNA resulting in cell damage and death. ROS from these therapies also indiscriminately target healthy non-neoplastic DNA.

Zinc carries out its antioxidant function in two ways: Reducing the concentration of oxidant agents and protecting structures and macromolecules suffer from oxidant agent.

N-acetylcysteine is an aminothiol and precursor to glutathione (GSH), glutathione in its reduced form is the most powerful intracellular antioxidant, thereby protecting against radiation-induced free radical damage.

our study is A randomized, controlled, parallel clinical trial that will be applied at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to investigate the prophylactic and therapeutic effect of N-acetylcysteine and zinc on radiotherapy induced oral mucositis in Head and Neck cancer patients.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria

Inclusion Criteria:

• Patients aged 18 years or older.
• Patients diagnosed with head and neck cancer.
• Patients are recommended for treatment with radiotherapy with a minimum dose of 20 Gy.

Exclusion Criteria:

• Pregnancy and lactating women.
• Cigarette smoker patients.
• Patients with severe comorbid illnesses or immunocompromised status.
• Patients receiving induction chemotherapy or those with previous head and neck radiotherapy. Patients using Amifostine during radiotherapy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 5 patient groups

Group 1

Experimental group

Description:

Intervention Type: Drug Intervention Name: N-acetylcysteine (NAC) Other Intervention Names: NAC Intervention Description: Patients will receive N-acetylcysteine sachets (600mg) twice daily. They will dissolve the NAC sachet in a cup of water, gargle for 60 seconds, and swallow it. The treatment will start 3 days before the beginning of radiotherapy and continue for 2 weeks after the completion of the radiotherapy schedule.

Treatment:

Drug: N-acetyl cysteine

Group2

Experimental group

Description:

Arm 2 Intervention Type: Drug Intervention Name: Zinc sulfate Other Intervention Names: Zinc Intervention Description: Patients will receive zinc sulfate capsules (25mg) thrice daily at 8-hour intervals. The treatment will start 3 days before the beginning of radiotherapy and continue for 2 weeks after the completion of the radiotherapy schedule.

Treatment:

Drug: Zinc sulfate

Group 3

Experimental group

Description:

Arm 3 Intervention Type: Combination Product Intervention Name: N-acetylcysteine (NAC) and zinc sulfate Other Intervention Names: NAC and Zinc Intervention Description: Patients will receive N-acetylcysteine sachets (600mg) twice daily and zinc sulfate capsules (25mg) thrice daily. They will dissolve the NAC sachet in a cup of water, gargle for 60 seconds, and swallow it. The treatment will start 3 days before the beginning of radiotherapy and continue for 2 weeks after the completion of the radiotherapy schedule.

Treatment:

Drug: Zinc sulfate

Drug: N-acetyl cysteine

Group 4

Experimental group

Description:

Intervention Type: Combination Product Intervention Name: N-acetylcysteine (NAC) and zinc sulfate after mucositis onset Other Intervention Names: NAC and Zinc post-mucositis Intervention Description: Patients who already began their radiotherapy and developed oral mucositis will receive N-acetylcysteine sachets (600mg) twice daily and zinc sulfate capsules (25mg) thrice daily. They will dissolve the NAC sachet in a cup of water, gargle for 60 seconds, and swallow it. The treatment will continue for 2 weeks after the completion of the radiotherapy schedule.

Treatment:

Drug: Zinc sulfate

Drug: N-acetyl cysteine

Group 5

Active Comparator group

Description:

Intervention Type: Other Intervention Name: Standard care (normal saline mouthwash) Other Intervention Names: Saline mouthwash Intervention Description: Patients will receive the institutional standard care, which is a normal saline mouthwash. The treatment will start 3 days before the beginning of radiotherapy and continue for 2 weeks after the completion of the radiotherapy schedule. Patients who develop any grade of oral mucositis will be treated according to the institutional standard treatment protocol.

Treatment:

Drug: saline mouth wash