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AzTrials

Head Cancer NeckPhase 2NCT03541772

Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

A Phase 2 study testing Oncoxin-Viusid® in people with Head Cancer Neck, run by Catalysis SL at 1 site in Cuba.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head Cancer Neck
What is being tested?
Oncoxin-Viusid®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteCuba
Study dates
20 Jan 2015to 30 Oct 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Cuba1 site

  • National Institute of Oncology and Radiobiology of Cuba

    Vedado, La Habana, 10400

Other trials in Cuba

About this study

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

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.

Read the 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.

Being tested
Oncoxin-Viusid®, Placebo
Keywords
Head Carcinoma, Neck Carcinoma, Chemotherapy, Radiotherapy, Oncoxin Viusid, Nutritional supplement
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • PlaceboDietary supplement

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

Study groups in NCT03541772
Study groupRoleWhat they receive
Oncoxin-Viusid®ExperimentalRadiotherapy + Chemotherapy + Oncoxin-viusid®
Receives: Dietary Supplement: Oncoxin-Viusid®
PlaceboPlacebo comparatorRadiotherapy + Chemotherapy + Placebo
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    Tumor biopsy

    Measured: 4 months

  2. Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    Biochemical analysis of urine

    Measured: 4 months

  3. Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    anamnesis

    Measured: 4 months

  4. Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    physical examination

    Measured: 4 months

  5. Improve the quality of life of patients during radiotherapy

    Index of Karnofsky

    Measured: 4 months

Secondary outcomes (1)

  1. Duration of the therapeutic range of radiotherapy

    Kaplan-Meyer's Method

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2018
  2. Study start20 Jan 2015
  3. Primary completion16 Oct 2017
  4. Study completion30 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03541772
Sponsor's protocol ID
OOS-CANCER-1
Status last verified
May 2018
First submitted
24 Apr 2018
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 17368656

  • 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.

    PubMed 11013273

  • 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.

    PubMed 11849797

  • 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.

    PubMed 18173999

  • 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.

    PubMed 11302780

  • 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.

    PubMed 26676882

  • 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.

    PubMed 19493854

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

    PubMed 10559547

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

    PubMed 10767670

  • 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.

    PubMed 19148586

  • 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.

    PubMed 28599406

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oncoxin-Viusid® in people with Head Cancer Neck, run by Catalysis SL at 1 site in Cuba.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease the degrees of toxicities of Radiotherapy and Chemotherapy (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03541772, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

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