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Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

Primary Purpose

Head Cancer Neck

Status

Completed

Phase

Phase 2

Locations

Cuba

Study Type

Interventional

Intervention

Oncoxin-Viusid®

Placebo

About this trial

This is an interventional supportive care trial for Head Cancer Neck focused on measuring Head Carcinoma, Neck Carcinoma, Chemotherapy, Radiotherapy, Oncoxin Viusid, Nutritional supplement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Institute of Oncology and Radiobiology of Cuba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oncoxin-Viusid®

Placebo

Arm Description

Radiotherapy + Chemotherapy + Oncoxin-viusid®

Radiotherapy + Chemotherapy + Placebo

Outcomes

Primary Outcome Measures

Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

Tumor biopsy

Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

Biochemical analysis of urine

Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

anamnesis

Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

physical examination

Improve the quality of life of patients during radiotherapy

Index of Karnofsky

Secondary Outcome Measures

Duration of the therapeutic range of radiotherapy

Kaplan-Meyer's Method

Full Information

NCT ID

NCT03541772

First Posted

April 24, 2018

Last Updated

June 4, 2018

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT03541772

Brief Title

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

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

January 20, 2015 (Actual)

Primary Completion Date

October 16, 2017 (Actual)

Study Completion Date

October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catalysis SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Cancer Neck

Keywords

Head Carcinoma, Neck Carcinoma, Chemotherapy, Radiotherapy, Oncoxin Viusid, Nutritional supplement

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oncoxin-Viusid®

Arm Type

Experimental

Arm Description

Radiotherapy + Chemotherapy + Oncoxin-viusid®

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Radiotherapy + Chemotherapy + Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Oncoxin-Viusid®

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

Description

Tumor biopsy

Time Frame

4 months

Title

Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

Description

Biochemical analysis of urine

Time Frame

4 months

Title

Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

Description

anamnesis

Time Frame

4 months

Title

Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

Description

physical examination

Time Frame

4 months

Title

Improve the quality of life of patients during radiotherapy

Description

Index of Karnofsky

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Duration of the therapeutic range of radiotherapy

Description

Kaplan-Meyer's Method

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivonne Chon, Dr.

Organizational Affiliation

INOR

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Oncology and Radiobiology of Cuba

City

Vedado

State/Province

La Habana

ZIP/Postal Code

10400

Country

Cuba

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

17368656

Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

11849797

Citation

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.

Results Reference

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PubMed Identifier

18173999

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.

Results Reference

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PubMed Identifier

11302780

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.

Results Reference

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PubMed Identifier

26676882

Citation

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.

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PubMed Identifier

19493854

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. French.

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PubMed Identifier

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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.

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PubMed Identifier

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Citation

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

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PubMed Identifier

19148586

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.

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PubMed Identifier

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Citation

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.

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Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

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