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

Mucositis Oral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577535
• Other study ID #: OOS-CANCER-10
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2017
• Est. completion date: July 15, 2018

Study information

• Verified date: June 2018
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 15, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Mucositis Oral
• Stomatitis

Intervention

Dietary Supplement:
• Oncoxin®
Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days;

Locations

Country	Name	City	State
Russian Federation	Medical Scientific centre of professor Shumsky	Samara	Samara Oblast

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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