Clinical trial · Interventional
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.
NCT03577535CI-TRIAL-00034081completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis Oral | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncoxin® | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oncoxin®
- description
- Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN
- interventionNames
- Dietary Supplement: Oncoxin®
- type
- NO_INTERVENTION
- label
- No Oncoxin Treatment®
- description
- Chemo-, radiotherapy or their combination + standard oral mucositis treatment.
Primary outcomes (1)
- measure
- Oral mucositis grade in patients during chemotherapy and radiotherapy treatments
- timeFrame
- 21 days
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.