Mucositis OralPhase 2NCT03577535
Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.
A Phase 2 study testing Oncoxin® in people with Mucositis Oral, run by Catalysis SL at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Mucositis Oral
- What is being tested?
- Oncoxin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2017to 15 Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- If the patient fails to comply with the requirements;
- Patient's refusal to participate in the study;
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Medical Scientific centre of professor Shumsky
Samara, Samara Oblast, 4433030
About this study
Official title: Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients. Real World Setting Study.
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.
Read the 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
- Being tested
- Oncoxin®
- Keywords
- Oral Mucositis, Nutritional supplement, Chemotherapy, Radiotherapy, Ocoxin / Oncoxin
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncoxin®Dietary supplement
Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days;
| Study group | Role | What they receive |
|---|---|---|
| Oncoxin® | Experimental | Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN Receives: Dietary Supplement: Oncoxin® |
| No Oncoxin Treatment® | No intervention | Chemo-, radiotherapy or their combination + standard oral mucositis treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
Secondary outcomes (3)
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.
Measured: 21 days
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.
Measured: 21 days
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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Nov 2017
- Primary completion31 May 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucositis OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577535
- Sponsor's protocol ID
- OOS-CANCER-10
- Status last verified
- Jun 2018
- First submitted
- 11 Jun 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients. Real World Setting Study.
- ClinicalTrials.gov ID
- NCT03577535
- Acronym / sponsor ID
- OOS-CANCER-10
- Conditions
- Mucositis Oral
- Keywords
- Oral Mucositis, Nutritional supplement, Chemotherapy, Radiotherapy, Ocoxin / Oncoxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncoxin® | Experimental | Dietary Supplement: Oncoxin®Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN |
| No Oncoxin Treatment® | No intervention | –Chemo-, radiotherapy or their combination + standard oral mucositis treatment. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncoxin®Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days; | Dietary supplement | Oncoxin® |
Primary outcome
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
3 secondary outcomes
Nutritional status of the patients during Chemotherapy and radiotherapy treatments related with weight gain
Time frame: 21 days
Nutritional status of the patients during Chemotherapy and radiotherapy treatments
Time frame: 21 days
Nutritional status of the patients during Chemotherapy and radiotherapy treatments
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oncoxin® in people with Mucositis Oral, run by Catalysis SL at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral mucositis grade in patients during chemotherapy and radiotherapy treatments (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.