NCT03577535

Brief Summary

Oral mucositis is one of the most spread side effects of anticancer therapy. It is associated with both chemo- and radiotherapy, decreases QoL, relative dose intensity and leads to nutritive deficiency. Oral mucositis causes secondary infections, increased hospital stay, whereas pain syndrome results in an emotional distress, anorexia and disables natural feeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2017

Shorter than P25 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

November 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2018

Completed
Last Updated

August 1, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

June 11, 2018

Last Update Submit

July 31, 2018

Conditions

Mucositis Oral

Keywords

Oral MucositisNutritional supplementChemotherapyRadiotherapyOcoxin / Oncoxin

Outcome Measures

Primary Outcomes (1)

  • Oral mucositis grade in patients during chemotherapy and radiotherapy treatments

    Efficacy of OCOXIN on oral mucositis symptoms in patients who receive chemotherapy and/or radiotherapy with WHO oral toxicity scale grades. The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis. WHO Oral Mucositis Grading Scale: * 0 (none): None * I (mild): Oral soreness, erythema * II (moderate): Oral erythema, ulcers, solid diet tolerated * III (severe): Oral ulcers, liquid diet only * IV (life-threatening): Oral alimentation impossible

    21 days

Secondary Outcomes (3)

  • Nutritional status of the patients during Chemotherapy and radiotherapy treatments related with weight gain

    21 days

  • Nutritional status of the patients during Chemotherapy and radiotherapy treatments

    21 days

  • Nutritional status of the patients during Chemotherapy and radiotherapy treatments

    21 days

Study Arms (2)

Oncoxin®

EXPERIMENTAL

Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN

Dietary Supplement: Oncoxin®

No Oncoxin Treatment®

NO INTERVENTION

Chemo-, radiotherapy or their combination + standard oral mucositis treatment.

Interventions

Oncoxin®DIETARY_SUPPLEMENT

Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days;

Oncoxin®

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A signed and dated informed consent form;
  • Patients of both genders, aged 45-75;
  • Malignant neoplasms which have radio-, chemotherapy or their combinations prescribed;
  • ECOG ≤3;
  • WHO oral toxicity scale grade 2 - 3.

You may not qualify if:

  • Significant, according to the investigator judgement, concomitant diseases or states which make it complicate or even impossible the patient's participation in the study or make it difficult to interpret the clinical data obtained in any stage of the study always including the following:
  • Mental disorders;
  • Serious/chronic infectious and parasitic diseases;
  • Intolerability to any of ONCOXIN components.
  • Relations with study center personnel (study center staff or family member of the investigator, coordinator or assistant).
  • If the patient fails to assess his/her physical and emotional condition;
  • If the patient fails to comply with the requirements;
  • Patient's refusal to participate in the study;
  • Pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Scientific centre of professor Shumsky

Samara, Samara Oblast, 4433030, Russia

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

July 5, 2018

Study Start

November 1, 2017

Primary Completion

May 31, 2018

Study Completion

July 15, 2018

Last Updated

August 1, 2018

Record last verified: 2018-06

Data Sharing

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

Locations

RU(1)