Clinical trial NCT03541772: Evaluation of Oncoxin-Viusid® in Head and Neck Cancer
Official title: "Combined Oncoxin-Viusid® Treatment With Radiotherapy and Chemotherapy in Patients With Head and Neck Cancer. Phase II, Randomized and Double-blind Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head Cancer Neck
Keywords: Head Carcinoma
Neck Carcinoma
Chemotherapy
Radiotherapy
Oncoxin Viusid
Nutritional supplement
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Nutritional supplements containing antioxidants seem to decrease toxicity associated with Radiotherapy (RT) and Chemotherapy (CT) in patients with malignant head and neck tumors. Oncoxin-Viusid® (OV) is a nutritional supplement with antioxidant, immunomodulator and antitumor effects.

Detailed description: Objective

To assess the efficacy and safety of OV in patients with head and neck tumors during treatment with radio-chemotherapy.

Materials and Methods

Patients diagnosed with Head and Neck Carcinoma, and indicated to follow a radiotherapy treatment concurrent with Radiosensitizing Chemotherapy, were included in a phase II, randomized, prospective, controlled and double-blind study in two treatment arms: RT + CT + Placebo (n = 30) and RT + CT + OV (n = 30) during one year in a tertiary center (INOR), with the aim of evaluating the reduction of toxicities of RT-CT and improve the quality of life of patients during these oncospecific treatments.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* over 18 years of age
* With histological diagnosis of carcinoma of the head and neck
* Regardless of the variety or degree of histological differentiation and clinical stage
* Tributaries of concomitant treatment with ionizing radiation and radiosensitizing chemotherapy with intercurrent diseases compensated and index of Karnofsky \> 59
* Acceptable hematological parameters
* Women not pregnant or lactating
* Who authorized their inclusion in the investigation, through their informed consent.

Exclusion Criteria:

* Patients with a second concomitant primary tumor and / or contraindication to platinum chemotherapy
* Patients who are under another research protocol or who have decompensated psychiatric disorders.

Primary outcomes:
measure: Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
timeFrame: 4 months
measure: Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
timeFrame: 4 months
measure: Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
timeFrame: 4 months
measure: Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
timeFrame: 4 months
measure: Improve the quality of life of patients during radiotherapy
timeFrame: 4 months
Secondary outcomes:
measure: Duration of the therapeutic range of radiotherapy
timeFrame: 4 months
Other outcomes:
Locations:
city: Vedado
country: Cuba
facility: National Institute of Oncology and Radiobiology of Cuba
state: La Habana
Study officials:
affiliation: INOR
name: Ivonne Chon, Dr.
role: PRINCIPAL_INVESTIGATOR
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