NCT03541772

Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

"Combined Oncoxin-Viusid® Treatment With Radiotherapy and Chemotherapy in Patients With Head and Neck Cancer. Phase II, Randomized and Double-blind Study"

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head Cancer Neck

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oncoxin-Viusid®	Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and Oncoxin-Viusid® (75 ml/day) before/during/after both treatments
DIETARY_SUPPLEMENT	Placebo	Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and placebo (75ml/day) before/during/after both treatments

Timeline

• Start date: 2015-01-20
• Primary completion: 2017-10-16
• Completion: 2017-10-30
• First posted: 2018-05-31
• Last updated: 2018-06-06

Locations

1 site across 1 country: Cuba