Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncoxin® | Experimental | Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN |
|
| No Oncoxin Treatment® | No Intervention | Chemo-, radiotherapy or their combination + standard oral mucositis treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncoxin® | Dietary Supplement | Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days; |
|
| 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:
| 21 days |
| 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 |
Not provided
Inclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Scientific centre of professor Shumsky | Samara | Samara Oblast | 4433030 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |