Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.

Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients. Real World Setting Study.

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.

Study Overview

• Status: Completed
• Conditions: Mucositis Oral
• Intervention / Treatment: Dietary supplement: Oncoxin®

Detailed Description

Primary:

To evaluate the efficacy of ONCOXIN on oral mucositis symptoms in patients who receive chemotherapy and/or radiotherapy.

Secondary:

To evaluate the effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Samara Oblast
    • Samara, Samara Oblast, Russian Federation, 4433030
      • Medical Scientific centre of professor Shumsky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Relations with study center personnel (study center staff or family member of the investigator, coordinator or assistant).
3. If the patient fails to assess his/her physical and emotional condition;
4. If the patient fails to comply with the requirements;
5. Patient's refusal to participate in the study;
6. Pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oncoxin®; Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN	Dietary supplement: Oncoxin®; Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days;
NO_INTERVENTION: No Oncoxin Treatment®; Chemo-, radiotherapy or their combination + standard oral mucositis treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status of the patients during Chemotherapy and radiotherapy treatments related with weight gain	Effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy measured with body mass measures.	21 days
Nutritional status of the patients during Chemotherapy and radiotherapy treatments	Effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy measured with days with the intake of regular food.	21 days
Nutritional status of the patients during Chemotherapy and radiotherapy treatments	Effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy measured with days with no loss of appetite complaints.	21 days

Collaborators and Investigators

• Sponsor: Catalysis SL

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): May 31, 2018
• Study Completion (ACTUAL): July 15, 2018

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (ACTUAL): July 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Radiotherapy; Chemotherapy; Nutritional supplement; Oral Mucositis; Ocoxin / Oncoxin
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: OOS-CANCER-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No