Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

Head Cancer Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541772
• Other study ID #: OOS-CANCER-1
• Status: Completed
• Phase: Phase 2
• Start date: January 20, 2015
• Est. completion date: October 30, 2017

Study information

• Verified date: May 2018
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head Cancer Neck

Intervention

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
• Placebo
Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and placebo (75ml/day) before/during/after both treatments

Locations

Country	Name	City	State
Cuba	National Institute of Oncology and Radiobiology of Cuba	Vedado	La Habana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

References & Publications (11)

Antonadou D, Pepelassi M, Synodinou M, Puglisi M, Throuvalas N. Prophylactic use of amifostine to prevent radiochemotherapy-induced mucositis and xerostomia in head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):739-47. — View Citation

Bardia A, Tleyjeh IM, Cerhan JR, Sood AK, Limburg PJ, Erwin PJ, Montori VM. Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis. Mayo Clin Proc. 2008 Jan;83(1):23-34. doi: 10.4065/83.1.23. Review. — View Citation

Brizel DM, Wasserman TH, Henke M, Strnad V, Rudat V, Monnier A, Eschwege F, Zhang J, Russell L, Oster W, Sauer R. Phase III randomized trial of amifostine as a radioprotector in head and neck cancer. J Clin Oncol. 2000 Oct 1;18(19):3339-45. Erratum in: J Clin Oncol 2000 Dec 15;18(24):4110-1. — View Citation

Hernandez-Unzueta I, Benedicto A, Olaso E, Sanz E, Viera C, Arteta B, Márquez J. Ocoxin oral solution(®) as a complement to irinotecan chemotherapy in the metastatic progression of colorectal cancer to the liver. Oncol Lett. 2017 Jun;13(6):4002-4012. doi: 10.3892/ol.2017.6016. Epub 2017 Apr 10. — View Citation

Lamson DW, Brignall MS. Antioxidants and cancer therapy II: quick reference guide. Altern Med Rev. 2000 Apr;5(2):152-63. — View Citation

Lamson DW, Brignall MS. Antioxidants in cancer therapy; their actions and interactions with oncologic therapies. Altern Med Rev. 1999 Oct;4(5):304-29. Review. — View Citation

Lamson DW, Brignall MS. Natural agents in the prevention of cancer, part two: preclinical data and chemoprevention for common cancers. Altern Med Rev. 2001 Apr;6(2):167-87. Review. — View Citation

Mahdavi R, Faramarzi E, Seyedrezazadeh E, Mohammad-Zadeh M, Pourmoghaddam M. Evaluation of oxidative stress, antioxidant status and serum vitamin C levels in cancer patients. Biol Trace Elem Res. 2009 Jul;130(1):1-6. doi: 10.1007/s12011-008-8309-2. Epub 2009 Jan 17. — View Citation

Marín Caro MM, Laviano A, Pichard C. Nutritional intervention and quality of life in adult oncology patients. Clin Nutr. 2007 Jun;26(3):289-301. Epub 2007 Mar 21. Review. — View Citation

Márquez J, Mena J, Hernandez-Unzueta I, Benedicto A, Sanz E, Arteta B, Olaso E. Ocoxin® oral solution slows down tumor growth in an experimental model of colorectal cancer metastasis to the liver in Balb/c mice. Oncol Rep. 2016 Mar;35(3):1265-72. doi: 10.3892/or.2015.4486. Epub 2015 Dec 16. — View Citation

Rodrigues MJ, Bouyon A, Alexandre J. [Role of antioxidant complements and supplements in oncology in addition to an equilibrate regimen: a systematic review]. Bull Cancer. 2009 Jun;96(6):677-84. doi: 10.1684/bdc.2009.0886. Review. French. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease the degrees of toxicities of Radiotherapy and Chemotherapy	Tumor biopsy	4 months
Primary	Decrease the degrees of toxicities of Radiotherapy and Chemotherapy	Biochemical analysis of urine	4 months
Primary	Decrease the degrees of toxicities of Radiotherapy and Chemotherapy	anamnesis	4 months
Primary	Decrease the degrees of toxicities of Radiotherapy and Chemotherapy	physical examination	4 months
Primary	Improve the quality of life of patients during radiotherapy	Index of Karnofsky	4 months
Secondary	Duration of the therapeutic range of radiotherapy	Kaplan-Meyer's Method	4 months