Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.
Primary Purpose
Mucositis Oral
Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Oncoxin®
Sponsored by
About this trial
This is an interventional supportive care trial for Mucositis Oral focused on measuring Oral Mucositis, Nutritional supplement, Chemotherapy, Radiotherapy, Ocoxin / Oncoxin
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Medical Scientific centre of professor Shumsky
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oncoxin®
No Oncoxin Treatment®
Arm Description
Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN
Chemo-, radiotherapy or their combination + standard oral mucositis treatment.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03577535
Brief Title
Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.
Official Title
Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients. Real World Setting Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
July 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral
Keywords
Oral Mucositis, Nutritional supplement, Chemotherapy, Radiotherapy, Ocoxin / Oncoxin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oncoxin®
Arm Type
Experimental
Arm Description
Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN
Arm Title
No Oncoxin Treatment®
Arm Type
No Intervention
Arm Description
Chemo-, radiotherapy or their combination + standard oral mucositis treatment.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oncoxin®
Intervention Description
Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days;
Primary Outcome Measure Information:
Title
Oral mucositis grade in patients during chemotherapy and radiotherapy treatments
Description
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
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Nutritional status of the patients during Chemotherapy and radiotherapy treatments related with weight gain
Description
Effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy measured with body mass measures.
Time Frame
21 days
Title
Nutritional status of the patients during Chemotherapy and radiotherapy treatments
Description
Effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy measured with days with the intake of regular food.
Time Frame
21 days
Title
Nutritional status of the patients during Chemotherapy and radiotherapy treatments
Description
Effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy measured with days with no loss of appetite complaints.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Medical Scientific centre of professor Shumsky
City
Samara
State/Province
Samara Oblast
ZIP/Postal Code
4433030
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.
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