NCT03562897

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2018

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

First Submitted

Initial submission to the registry

May 25, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

July 6, 2022

Status Verified

October 1, 2021

Enrollment Period

3.3 years

First QC Date

May 25, 2018

Last Update Submit

July 5, 2022

Conditions

CarcinomaOvarian NeoplasmEndocrine Gland NeoplasmUrogenital NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsEndocrine System DiseasesGonadal DisordersGenital Neoplasm, FemaleNeoplasms, Glandular and Epithelial

Keywords

Dietary supplementsOcoxin-ViusidNutritional supplementOvarian CancerMetastasis

Outcome Measures

Primary Outcomes (3)

  • Quality of life

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

    4 months

  • Quality of life

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

    4 months

  • Quality of life

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

    4 months

Secondary Outcomes (1)

  • Nutritional State

    4 months

Study Arms (1)

Ocoxin-Viusid®

EXPERIMENTAL

Ocoxin-Viusid® before, during and after the Chemotherapy treatment.

Dietary Supplement: Ocoxin-Viusid

Interventions

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).

Ocoxin-Viusid®

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Oncology and Radiobiology (INOR)

Havana, 10400, Cuba

Location

Related Publications (14)

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

    PMID: 22987944BACKGROUND

  • 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.

    PMID: 21521830BACKGROUND

  • 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.

    PMID: 25559415BACKGROUND

  • 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.

    PMID: 18195328BACKGROUND

  • 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.

    PMID: 23945413BACKGROUND

  • 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.

    PMID: 19484479BACKGROUND

  • 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.

    PMID: 20803205BACKGROUND

  • 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.

    PMID: 21843153BACKGROUND

  • 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.

    PMID: 24027084BACKGROUND

  • 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.

    PMID: 25216721BACKGROUND

  • 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.

    PMID: 9713300BACKGROUND

  • 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. 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

  • 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.

    PMID: 26905163BACKGROUND

MeSH Terms

Conditions

CarcinomaOvarian NeoplasmsEndocrine Gland NeoplasmsUrogenital NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsEndocrine System DiseasesGonadal DisordersGenital Neoplasms, FemaleNeoplasms, Glandular and EpithelialNeoplasm Metastasis

Interventions

Ocoxin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsNeoplasms by SiteUrogenital DiseasesGenital DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 20, 2018

Study Start

October 25, 2018

Primary Completion

February 15, 2022

Study Completion

June 15, 2022

Last Updated

July 6, 2022

Record last verified: 2021-10

Data Sharing

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

Locations

CU(1)