Clinical trial NCT05023863: The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients
Official title: The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Radiation-Induced Mucositis
Keywords: Head and Neck cancer
Alpha Lipoic Acid
Mucositis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, controlled, single blinded study
Primary purpose: PREVENTION

Brief summary: A prospective, randomized, controlled, single-blinded study will be conducted at Clinical Oncology department, Ain Shams University Hospitals, assessing the effect of Alpha Lipoic Acid on the incidence and severity of radiotherapy induced oral mucositis in Head and Neck cancer patients.

Detailed description: All patients presenting to the Clinical Oncology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:

Inclusion criteria:

* Age \>18 years.
* Diagnosis of stage I, II, III or IV squamous cell carcinoma, nasopharyngeal carcinoma.
* Measurable disease on CT scan at baseline.
* Planned to receive radiotherapy with a total dose 60 grays or more divided on 30 fractions with or without cisplatin (100 mg/m2, administered intravenously every 21 days for three cycles or 40 mg/m2 administered weekly for up to 7 weeks).
* Adequate liver function (liver transaminases level \< 3 times upper normal limits and total bilirubin \< 1.5 times upper normal limits).
* Adequate kidney function (estimated glomerular filtration rate \>60 ml/min).
* Adequate bone marrow function (WBCs count \> 3000 cells/mm3, ANC count \>1500 cells/mm3 and platelets count \> 100,000 cells/mm3).

Exclusion criteria:

Patients will be excluded if they have any of the following:

* Diagnosis of Thyroid cancer.
* Presence of other primary cancers.
* Treatment with alpha lipoic acid for any other indication.
* Allergy to alpha lipoic acid.
* Pregnant or lactating women. Eligible patients will be randomized to either... Alpha Lipoic Acid Group (intervention group): 35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). The medication will be brought from EVA company ( an Egyptian drug company ) under the trade name of thiotacid 600 mg tablets.

Control Group: 35 Patients will receive radiation therapy with or without platinum-based chemotherapy plus placebo tablets of thiotacid throughout the radiation period

All patients will be followed up weekly to assess the incidence and severity of radiation induced oral mucositis using the radiotherapy oncology group criteria also blood samples will be drawn at baseline , after three weeks (middle of radiation period) at the end of radiation period to asses changes in CRP and TAC levels

Eligibility criteria: Inclusion Criteria:

* • Age \>18 years.

  * Diagnosis of stage I, II, III or IV squamous cell carcinoma, nasopharyngeal carcinoma.
  * Measurable disease on CT scan at baseline.
  * Planned to receive radiotherapy with a total dose 60 grays or more divided on 30 fractions with or without cisplatin (100 mg/m2, administered intravenously every 21 days for three cycles or 40 mg/m2 administered weekly for up to 7 weeks).
  * Adequate liver function (liver transaminases level \< 3 times upper normal limits and total bilirubin \< 1.5 times upper normal limits).
  * Adequate kidney function (estimated glomerular filtration rate \>60 ml/min).
  * Adequate bone marrow function (WBCs count \> 3000 cells/mm3, ANC count \>1500 cells/mm3 and platelets count \> 100,000 cells/mm3).

Exclusion Criteria:

* ● Diagnosis of Thyroid cancer.

  * Presence of other primary cancers.
  * Treatment with alpha lipoic acid for any other indication.
  * Allergy to alpha lipoic acid.
  * Pregnant or lactating women.

Primary outcomes:
measure: Incidence and severity of radiation induced oral mucositis
timeFrame: 4 months
Secondary outcomes:
measure: Time to develop grade III or IV radiation induced oral mucositis:
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
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