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NCT Number: NCT03577535

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

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.

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Key information

Conditions

Mucositis Oral Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Scientific centre of professor Shumsky

Samara, Samara Oblast, 4433030, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A signed and dated informed consent form;
  • Patients of both genders, aged 45-75;
  • Malignant neoplasms which have radio-, chemotherapy or their combinations prescribed;
  • ECOG ≤3;
  • WHO oral toxicity scale grade 2 - 3.

Exclusion criteria

  • 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.
  • Relations with study center personnel (study center staff or family member of the investigator, coordinator or assistant).
  • If the patient fails to assess his/her physical and emotional condition;
  • If the patient fails to comply with the requirements;
  • Patient's refusal to participate in the study;
  • Pregnancy or lactation.

Treatment and study plan

Oncoxin®

Dietary Supplement

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

Primary outcomes

  1. Oral mucositis grade in patients during chemotherapy and radiotherapy treatments

    Time frame: 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 outcomes

  1. Nutritional status of the patients during Chemotherapy and radiotherapy treatments related with weight gain

    Time frame: 21 days

    Effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy measured with body mass measures.

  2. Nutritional status of the patients during Chemotherapy and radiotherapy treatments

    Time frame: 21 days

    Effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy measured with days with the intake of regular food.

  3. Nutritional status of the patients during Chemotherapy and radiotherapy treatments

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2018
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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