Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03541772
Other study ID # OOS-CANCER-1
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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 allClick 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04251481 - Diffusion MRI for Head and Neck Cancer N/A
Withdrawn NCT05472506 - Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer Phase 1
Completed NCT04419077 - Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act N/A
Not yet recruiting NCT05885490 - IReC-Bio and IReC Registry
Recruiting NCT04722523 - A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer Phase 1
Completed NCT04237090 - Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel Phase 3
Not yet recruiting NCT06366945 - Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC Phase 2