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

Phase 2

Completed

• Conditions: Mucositis Oral
• Interventions: Dietary Supplement: Oncoxin®

• Registration Number: NCT03577535
• Lead Sponsor: Catalysis SL

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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-05-31
• Status Verified: 2018-06
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-05
• Study Completion: 2018-07-15
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oncoxin®	Oncoxin®	Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN

Primary Outcome Measures

Name	Time	Method
Oral mucositis grade in patients during chemotherapy and radiotherapy treatments	21 days	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

Name	Time	Method
Nutritional status of the patients during Chemotherapy and radiotherapy treatments related with weight gain	21 days	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	21 days	Effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy measured with days with no loss of appetite complaints.

Trial Locations

Locations (1)

Medical Scientific centre of professor Shumsky; 🇷🇺 Samara, Samara Oblast, Russian Federation