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CarcinomaPhase 2NCT03562897

Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer

A Phase 2 study testing Ocoxin-Viusid in people with Carcinoma and Ovarian Neoplasm, 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

Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Ocoxin-Viusid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCuba
Study dates
25 Oct 2018to 15 Jun 2022
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients 18 years of age or older.
  • Patients with diagnosis of ovarian epithelial cancer in stages III (not resectable) and IV.
  • Patients with general health status according to the Karnofsky Index ≥ 70 (Annex 12).
  • Life expectancy equal to or greater than 3 months.
  • Patients who give their informed consent in writing to participate in the study.
  • Normal functioning of organs and bone marrow defined by the following parameters: -Hemoglobin ≥ 90 g / L - Total Leukocyte count ≥ 3.0 x 109 / L Absolute Neutrophil Count = 1.5 x 109 / L -Platelet count ≥ 100 x 109 / L -Glycemia values ≤ 10 Umol / L -Values of Creatinine and total bilirubin within the normal limits of the institution. -Values of AST / ALT ≤2.5 times the upper limit of the normal interval established in the institution.
  • Patients with a history of cardiovascular disease, with ejection fraction ≥ 55%, measured by echocardiogram.

Who cannot join

  • Patients who are receiving another research product.
  • Patients with known hypersensitivity to QT with Carboplatin, Cisplatin and / or Paclitaxel.
  • Patients in stage III tributary of surgical treatment at diagnosis.
  • Patients with known hypersensitivity to any ingredient of the product research.
  • Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver diseases and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health or life at risk during your participation in the trial.
  • Pregnancy, breastfeeding or puerperium.
  • Patients with brain metastases and/or leptomeningeal carcinosis.
  • Patients' carrier of the human immunodeficiency virus (HIV).

Trial locations and contacts

1 site in 1 country.

Cuba1 site

  • National Institute of Oncology and Radiobiology (INOR)

    Havana, 10400

Other trials in Cuba

About this study

Official title: Efficacy of the Oncoxin-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced or Metastatic Ovarian Epithelial Cancer. Clinical Trial Phase II.

Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.

Read the detailed description

General Objectives -To identify the efficacy of the nutritional supplement Ocoxin-viusid to increase the quality of life of patients with epithelial advanced or metastatic ovarian cancer. Specific Objectives - Identify the influence of the research product on the nutritional status and quality of life of patients. - Describe the toxicity of the research product. - Identify the adverse reactions to the chemotherapy scheme and quantify the interruptions to it by acute toxicity.

Quality of life. It will be measured as: - EORTC Questionnaire QLQ-C30 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - EORTC Questionnaire QLQ-OV28 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at the beginning, in each cycle of QT and 3 weeks after the 3rd cycle of QT

Being tested
Ocoxin-Viusid
Keywords
Dietary supplements, Ocoxin-Viusid, Nutritional supplement, Ovarian Cancer, Metastasis
Medical subject headings
Carcinoma, Ovarian Neoplasms, Endocrine Gland Neoplasms, Urogenital Neoplasms, Ovarian Diseases, Adnexal Diseases, Genital Diseases, Female, Female Urogenital Diseases

What participants receive

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

  • Ocoxin-ViusidDietary supplement

    Ocoxin-Viusid group (Experimental): Oral solution Ocoxin-Viusid (30 ml vials) were used at a rate of 60ml / day (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatment will start a week before start Chemotheray treatment (CT) and, It will maintenance until 3 weeks after finished the last cycle of CT (3 cycles of CT of Carboplatin/Paclitaxel or Cisplatin/ Paclitaxel with neoadjuvant intent).

Study groups in NCT03562897
Study groupRoleWhat they receive
Ocoxin-Viusid®ExperimentalOcoxin-Viusid® before, during and after the Chemotherapy treatment.
Receives: Dietary Supplement: Ocoxin-Viusid

What is being measured

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

  1. Quality of life

    It will measured by: - EORTC QLQ-C30 (Points of every item and final points)

    Measured: 4 months

  2. Quality of life

    Karnofsky index (Score of 0-100 points at intervals of 10)

    Measured: 4 months

  3. Quality of life

    EORTC QLQ-OV28 (Points of every item and final points)

    Measured: 4 months

Secondary outcomes (1)

  1. Nutritional State

    Body mass index

    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 posted20 Jun 2018
  2. Study start25 Oct 2018
  3. Primary completion15 Feb 2022
  4. Study completion15 Jun 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562897
Sponsor's protocol ID
OOS-CANCER-7
Status last verified
Oct 2021
First submitted
25 May 2018
Last updated
6 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Prat J. New insights into ovarian cancer pathology. Ann Oncol. 2012 Sep;23 Suppl 10:x111-7. doi: 10.1093/annonc/mds300.

    PubMed 22987944

  • Jelovac D, Armstrong DK. Recent progress in the diagnosis and treatment of ovarian cancer. CA Cancer J Clin. 2011 May-Jun;61(3):183-203. doi: 10.3322/caac.20113. Epub 2011 Apr 26.

    PubMed 21521830

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.

    PubMed 25559415

  • Landen CN Jr, Birrer MJ, Sood AK. Early events in the pathogenesis of epithelial ovarian cancer. J Clin Oncol. 2008 Feb 20;26(6):995-1005. doi: 10.1200/JCO.2006.07.9970. Epub 2008 Jan 14.

    PubMed 18195328

  • Fuchs-Tarlovsky V, Alvarez-Altamirano K, Turquie-Sacal D, Alvarez-Flores C, Hernandez-Steller H. Nutritional status and body composition are already affected before oncology treatment in ovarian cancer. Asia Pac J Clin Nutr. 2013;22(3):426-30. doi: 10.6133/apjcn.2013.22.3.12.

    PubMed 23945413

  • Gupta D, Lis CG, Vashi PG, Lammersfeld CA. Impact of improved nutritional status on survival in ovarian cancer. Support Care Cancer. 2010 Mar;18(3):373-81. doi: 10.1007/s00520-009-0670-y. Epub 2009 May 31.

    PubMed 19484479

  • Kathiresan AS, Brookfield KF, Schuman SI, Lucci JA 3rd. Malnutrition as a predictor of poor postoperative outcomes in gynecologic cancer patients. Arch Gynecol Obstet. 2011 Aug;284(2):445-51. doi: 10.1007/s00404-010-1659-y. Epub 2010 Aug 29.

    PubMed 20803205

  • Madhok BM, Yeluri S, Haigh K, Burton A, Broadhead T, Jayne DG. Parenteral nutrition for patients with advanced ovarian malignancy. J Hum Nutr Diet. 2011 Apr;24(2):187-91. doi: 10.1111/j.1365-277X.2010.01127.x.

    PubMed 21843153

  • Billson HA, Holland C, Curwell J, Davey VL, Kinsey L, Lawton LJ, Whitworth AJ, Burden S. Perioperative nutrition interventions for women with ovarian cancer. Cochrane Database Syst Rev. 2013 Sep 11;2013(9):CD009884. doi: 10.1002/14651858.CD009884.pub2.

    PubMed 24027084

  • Lohsiriwat V. The influence of preoperative nutritional status on the outcomes of an enhanced recovery after surgery (ERAS) programme for colorectal cancer surgery. Tech Coloproctol. 2014 Nov;18(11):1075-80. doi: 10.1007/s10151-014-1210-4. Epub 2014 Sep 13.

    PubMed 25216721

  • Andreyev HJ, Norman AR, Oates J, Cunningham D. Why do patients with weight loss have a worse outcome when undergoing chemotherapy for gastrointestinal malignancies? Eur J Cancer. 1998 Mar;34(4):503-9. doi: 10.1016/s0959-8049(97)10090-9.

    PubMed 9713300

  • 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. 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

  • Al-Mahtab M, Akbar SM, Khan MS, Rahman S. Increased survival of patients with end-stage hepatocellular carcinoma due to intake of ONCOXIN(R), a dietary supplement. Indian J Cancer. 2015 Jul-Sep;52(3):443-6. doi: 10.4103/0019-509X.176699.

    PubMed 26905163

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ocoxin-Viusid in people with Carcinoma and Ovarian Neoplasm, 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 7 inclusion and 8 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 Jul 2022. 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. 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?

Quality of life (time frame: 4 months). The study lists 3 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 NCT03562897, which also lists 14 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 Jul 2022.

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