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

NCT ID: NCT03577535

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-07-15

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.

Conditions

Mucositis Oral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Oncoxin®

Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN

Group Type: EXPERIMENTAL

Oncoxin®

Intervention Type: DIETARY_SUPPLEMENT

Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days;

No Oncoxin Treatment®

Chemo-, radiotherapy or their combination + standard oral mucositis treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oncoxin®

Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days;

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catalysis SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Scientific centre of professor Shumsky

Samara, Samara Oblast, Russia

Countries

Russia

Other Identifiers

OOS-CANCER-10

Identifier Type: -

Identifier Source: org_study_id