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

Catalysis SL

Status and phase: Completed; Phase 2

Conditions: Mucositis Oral

Treatments: Dietary Supplement: Oncoxin®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03577535

OOS-CANCER-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Oncoxin®

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oncoxin®

No Oncoxin Treatment®

No Intervention group

Description:

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