Radiotherapy; ComplicationsPhase 4NCT05046028
Individualization of Nutritive Sensory Support Of Radiation Therapy
A Phase 4 study testing Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet, ONS without a sensor component and taste + standard diet and Standard diet in people with Radiotherapy; Complications and Head and Neck Cancer, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
Trial summary
Nutritional deficiency and subsequent weight loss in patients with head and neck cancer is a common problem and a negative predictor of treatment outcomes and mortality, as well as quality of life. Nutritional support for patients is a prerequisite for the successful management of cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy; Complications, Head and Neck Cancer
- What is being tested?
- Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet, ONS without a sensor component and taste + standard diet and Standard diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 15 Dec 2020to 15 Dec 2022
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years
- The presence of morphological verification of squamous cell carcinoma of the head and neck
- No history of anticancer treatment
- ECOG score 0 - 2
- Life expectancy is more than 3 months
- Normal liver, kidney and bone marrow function
Show all 9Show fewer
- Absence of severe uncontrolled concomitant chronic diseases and acute diseases (including infectious diseases)
- Absence of pregnancy, lactation
- Initial compliance of patients (according to the consultation of a psychologist and questionnaires) with a signed informed consent
Who cannot join
- Simultaneous participation in another clinical trial
- Failure to meet inclusion criteria
- The patient's condition is ECOG ≥3, Karnovsky ≤40%.
- Bleeding
- Decay / Abscess in the area of tumor lesion
- Pregnancy or breastfeeding
- Refractory cachexia
- Allergy or intolerance to any of the components of ONS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Nutritional Support With High Protein Formula With Modified Sensory Component for H&N Cancer Patients on Chemo and Radiotherapy
Nutritional deficiency and subsequent weight loss in patients with head and neck cancer is a common problem and a negative predictor of treatment outcomes and mortality, as well as quality of life. Nutritional support for patients is a prerequisite for the successful management of cancer patients. Sensory changes can be side effects of chemotherapy or ionizing radiation, which damages sensory receptors in the area of radiation, disrupts the function of the salivary glands, leading to hyposalivation and a decrease in taste. Individual choice of nutrition based on sensory sensations can significantly improve the quality of life of patients and ensure timely correction of their eating behavior.
- Conditions
- Radiotherapy; Complications, Head and Neck Cancer
- Being tested
- Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet, ONS without a sensor component and taste + standard diet, Standard diet
- Keywords
- Nutritional support, Radiotherapy, Head and Neck Cancer, Complications
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard dietDietary supplement
ONS with a cooling effect and Red Fruits taste. 3 bottles (х 200 ml) per day X 14 days (at severe mucositis period) in addition to a standard diet and other ONS without a sensor component and taste according to protein and energy requirements based on ESPEN guidelines (protein 1.5 g/kg/day and Energy -25 and 30 kcal/kg/day)
ONS without a sensor component and taste + standard dietDietary supplement
Nutritional support + ONS without a sensor component and taste (cooling effect) in addition to a standard diet according to protein and energy requirements based on ESPEN guidelines (protein 1.5 g/kg/day and Energy -25 and 30 kcal/kg/day)
Standard dietDietary supplement
Without appropriate nutritional support - not in accordance with current ESPEN guidelines (protein and Energy intake less than 1.5 g/kg/day and 25 and 30 kcal/kg/day). (Historical retrospective control).
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | 50 patients with squamous cell head cancer over 18 years of age, receiving chemoradiation therapy, receiving 3 bottles (х 200 ml) of ONS with Protein Oncosensation with a neutral taste throughout the course of treatment. Receives: Dietary Supplement: Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet |
| Prospective Control group | Active comparator | 50 patients over 18 years of age with squamous cell carcinoma of the head and neck, receiving chemoradiation therapy, receiving standard nutritional therapy with a neutral taste throughout the course of treatment. Receives: Dietary Supplement: ONS without a sensor component and taste + standard diet |
| Retrospective Control group | Sham comparator | 60 patients who received chemoradiotherapy earlier with standard nutritional support. Receives: Dietary Supplement: Standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QoL)
QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
Measured: 1 year
Nutritional status
Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002
Measured: 1 year
Patient compliance
The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire.
Measured: 1 year
Secondary outcomes (10)
Tolerance to chemoradiation therapy - mucositis
Mucositis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: 4 months
Tolerance to chemoradiation therapy - dermatitis
Dermatitis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: 4 months
Terms of treatment
Terms of treatment is recorded in total number of days from the first day of radiation treatment to the last one.
Measured: during radiation treatment
Unplanned breaks
Days of delayed treatment
Measured: during radiation treatment
Efficiency of chemoradiation therapy
Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Measured: 1 year
1-year locoregional control
1-year locoregional control after chemoradiation therapy
Measured: 1 year
1-year overall survival
1-year overall survival is the percentage of people who are alive one year after they started chemoradiation therapy
Measured: 1 year
1-year relapse-free survival
1-year relapse-free survival is the percentage of people who have not had relaps one year after they started chemoradiation therapy
Measured: 1 year
Dynamics of sensory changes
Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale)
Measured: 1 year
Dynamics of pain syndrome
Dynamics of pain syndrome based on numerical rating scale (NRS scale)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start15 Dec 2020
- Primary completion15 May 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy; ComplicationsStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gevorkov Artem R, National Medical Research Radiological Centre of the Ministry of Health of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046028
- Sponsor's protocol ID
- INSSORT
- Status last verified
- Mar 2023
- First submitted
- 2 Jun 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Nutritional Support With High Protein Formula With Modified Sensory Component for H&N Cancer Patients on Chemo and Radiotherapy
- ClinicalTrials.gov ID
- NCT05046028
- Acronym / sponsor ID
- INSSORT
- Conditions
- Radiotherapy; Complications, Head and Neck Cancer
- Keywords
- Nutritional support, Radiotherapy, Head and Neck Cancer, Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 16 Sep 2021 (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.
Nutritional deficiency and subsequent weight loss in patients with head and neck cancer is a common problem and a negative predictor of treatment outcomes and mortality, as well as quality of life. Nutritional support for patients is a prerequisite for the successful management of cancer patients. Sensory changes can be side effects of chemotherapy or ionizing radiation, which damages sensory receptors in the area of radiation, disrupts the function of the salivary glands, leading to hyposalivation and a decrease in taste. Individual choice of nutrition based on sensory sensations can significantly improve the quality of life of patients and ensure timely correction of their eating behavior.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Dietary Supplement: Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet50 patients with squamous cell head cancer over 18 years of age, receiving chemoradiation therapy, receiving 3 bottles (х 200 ml) of ONS with Protein Oncosensation with a neutral taste throughout the course of treatment. |
| Prospective Control group | Active comparator | Dietary Supplement: ONS without a sensor component and taste + standard diet50 patients over 18 years of age with squamous cell carcinoma of the head and neck, receiving chemoradiation therapy, receiving standard nutritional therapy with a neutral taste throughout the course of treatment. |
| Retrospective Control group | Sham comparator | Dietary Supplement: Standard diet60 patients who received chemoradiotherapy earlier with standard nutritional support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age> 18 years
- The presence of morphological verification of squamous cell carcinoma of the head and neck
- No history of anticancer treatment
- ECOG score 0 - 2
- Life expectancy is more than 3 months
Key exclusion criteria (8 listed)
- Simultaneous participation in another clinical trial
- Failure to meet inclusion criteria
- The patient's condition is ECOG ≥3, Karnovsky ≤40%.
- Bleeding
- Decay / Abscess in the area of tumor lesion
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 |
|---|---|---|
| Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard dietONS with a cooling effect and Red Fruits taste. 3 bottles (х 200 ml) per day X 14 days (at severe mucositis period) in addition to a standard diet and other ONS without a sensor component and taste according to protein and energy requirements based on ESPEN guidelines (protein 1.5 g/kg/day and Energy -25 and 30 kcal/kg/day) | Dietary supplement | Test |
| ONS without a sensor component and taste + standard dietNutritional support + ONS without a sensor component and taste (cooling effect) in addition to a standard diet according to protein and energy requirements based on ESPEN guidelines (protein 1.5 g/kg/day and Energy -25 and 30 kcal/kg/day) | Dietary supplement | Prospective Control group |
| Standard dietWithout appropriate nutritional support - not in accordance with current ESPEN guidelines (protein and Energy intake less than 1.5 g/kg/day and 25 and 30 kcal/kg/day). (Historical retrospective control). | Dietary supplement | Retrospective Control group |
Primary outcome
Quality of life (QoL)
Time frame: 1 year
QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
Nutritional status
Time frame: 1 year
Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002
Patient compliance
Time frame: 1 year
The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire.
10 secondary outcomes
Tolerance to chemoradiation therapy - mucositis
Time frame: 4 months
Tolerance to chemoradiation therapy - dermatitis
Time frame: 4 months
Terms of treatment
Time frame: during radiation treatment
Unplanned breaks
Time frame: during radiation treatment
Efficiency of chemoradiation therapy
Time frame: 1 year
1-year locoregional control
Time frame: 1 year
1-year overall survival
Time frame: 1 year
1-year relapse-free survival
Time frame: 1 year
Dynamics of sensory changes
Time frame: 1 year
Dynamics of pain syndrome
Time frame: 1 year
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 24 Mar 2023.
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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 4 study testing Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet, ONS without a sensor component and taste + standard diet and Standard diet in people with Radiotherapy; Complications and Head and Neck Cancer, run by National Medical Research Radiological Centre of the Ministry of Health of Russia 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 9 inclusion and 8 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 24 Mar 2023. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Quality of life (QoL) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 24 Mar 2023.