NCT03541772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

2.7 years

First QC Date

April 24, 2018

Last Update Submit

June 4, 2018

Conditions

Head Cancer Neck

Keywords

Head CarcinomaNeck CarcinomaChemotherapyRadiotherapyOncoxin ViusidNutritional supplement

Outcome Measures

Primary Outcomes (5)

  • Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    Tumor biopsy

    4 months

  • Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    Biochemical analysis of urine

    4 months

  • Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    anamnesis

    4 months

  • Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    physical examination

    4 months

  • Improve the quality of life of patients during radiotherapy

    Index of Karnofsky

    4 months

Secondary Outcomes (1)

  • Duration of the therapeutic range of radiotherapy

    4 months

Study Arms (2)

Oncoxin-Viusid®

EXPERIMENTAL

Radiotherapy + Chemotherapy + Oncoxin-viusid®

Dietary Supplement: Oncoxin-Viusid®

Placebo

PLACEBO COMPARATOR

Radiotherapy + Chemotherapy + Placebo

Dietary Supplement: Placebo

Interventions

Oncoxin-Viusid®DIETARY_SUPPLEMENT

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

Oncoxin-Viusid®
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Oncology and Radiobiology of Cuba

Vedado, La Habana, 10400, Cuba

Location

Related Publications (11)

  • Marin Caro MM, Laviano A, Pichard C. Nutritional intervention and quality of life in adult oncology patients. Clin Nutr. 2007 Jun;26(3):289-301. doi: 10.1016/j.clnu.2007.01.005. Epub 2007 Mar 21.

    PMID: 17368656BACKGROUND

  • 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. doi: 10.1200/JCO.2000.18.19.3339.

    PMID: 11013273BACKGROUND

  • 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. doi: 10.1016/s0360-3016(01)02683-9.

    PMID: 11849797BACKGROUND

  • 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.

    PMID: 18173999BACKGROUND

  • 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.

    PMID: 11302780BACKGROUND

  • Marquez J, Mena J, Hernandez-Unzueta I, Benedicto A, Sanz E, Arteta B, Olaso E. Ocoxin(R) 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.

    PMID: 26676882BACKGROUND

  • 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. French.

    PMID: 19493854BACKGROUND

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

    PMID: 10559547BACKGROUND

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

    PMID: 10767670BACKGROUND

  • 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.

    PMID: 19148586BACKGROUND

  • Hernandez-Unzueta I, Benedicto A, Olaso E, Sanz E, Viera C, Arteta B, Marquez J. Ocoxin oral solution(R) 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.

    PMID: 28599406BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Ivonne Chon, Dr.

    INOR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 31, 2018

Study Start

January 20, 2015

Primary Completion

October 16, 2017

Study Completion

October 30, 2017

Last Updated

June 6, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU(1)