Oral MucositisPhase 2NCT05101889
Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation
A Phase 2 study testing Oral Impact® in people with Oral Mucositis, run by Prince of Songkla University.
Trial summary
This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Oral Impact®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2013to 31 Jan 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of 18-65 years
- histological confirmation of stage II-IVb non-metastatic HNC according to the seventh edition of the American Joint Committee on Cancer Staging System (AJCC 2010)
- receipt of definitive CCRT
- Eastern Cooperative Oncology Group performance status of 0-1
- creatinine clearance ≥ 60 mL/min/1.73 m2 calculated by the Cockcroft-Gault formula
- absence of mucositis
- able to tolerate oral feeding
Who cannot join
- receipt of curative surgery for HNC
- allergies to any component of the immunonutrition
About this study
Official title: Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study
This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.
- Conditions
- Oral Mucositis
- Being tested
- Oral Impact®
- Keywords
- head and neck cancer, nasopharyngeal cancer, immunonutrition, concurrent chemoradiation, survival
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Impact®Dietary supplement
Also called Blendera®
3 ready-to-drink bottles/day
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition | Experimental | Oral immunomodulating formula (Oral Impact®, Nestle) One sachet of Oral Impact® consisted of 74 g of powder providing 303 kilocalories.
Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session. Receives: Dietary Supplement: Oral Impact® |
| Control | Active comparator | An isocaloric isonitrogenous standard enteral nutrition formula. Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session. Receives: Dietary Supplement: Oral Impact® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria
Proportion of severe oral mucositis between two groups
Measured: 6 weeks after initiation of concurrent chemoradiation (CCRT)
Secondary outcomes (11)
Other treatment-related toxicities graded according to the NCI CTCAE version 4.03 criteria
Proportion of patients with other treatment-related toxicities between two groups
Measured: through study completion, an average of 6 weeks
body weight in kilograms
mean changes of body weight between two groups
Measured: 6 weeks after initiation of CCRT and 1 month after CCRT completion
serum albumin in grams per deciliter (g/dL)
mean serum albumin between two groups
Measured: 6 weeks after initiation of CCRT and 1 month after CCRT completion
hemoglobin in grams per deciliter (g/dL)
mean hemoglobin between two groups
Measured: 6 weeks after initiation of CCRT and 1 month after CCRT completion
C-reactive protein (CRP) in milligrams per liter (mg/L)
mean CRP between two groups
Measured: 6 weeks after initiation of CCRT and 1 month after CCRT completion
neutrophil-to-lymphocyte ratio (NLR)
mean NLR between two groups
Measured: 6 weeks after initiation of CCRT and 1 month after CCRT completion
platelet-to-lymphocyte ratio (PLR)
mean PLR between two groups
Measured: 6 weeks after initiation of CCRT and 1 month after CCRT completion
actual dose of radiation in centigrays (cGy)
mean actual dose of radiation between two groups
Measured: through study completion, an average of 6 weeks
cumulative dose of cisplatin in milligrams per square meter (mg/m2)
mean cumulative dose of cisplatin between two groups
Measured: through study completion, an average of 6 weeks
progression-free survival (PFS)
compare PFS between two groups
Measured: at 3 years
overall survival (OS)
compare OS between two groups
Measured: at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start11 Jan 2013
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- phase II randomized, double-blind study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arunee Dechaphunkul, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101889
- Sponsor's protocol ID
- REC.56-036-13-1-1
- Status last verified
- Oct 2021
- First submitted
- 29 Sep 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dechaphunkul T, Arundon T, Raungkhajon P, Jiratrachu R, Geater SL, Dechaphunkul A. Benefits of immunonutrition in patients with head and neck cancer receiving chemoradiation: A phase II randomized, double-blind study. Clin Nutr. 2022 Feb;41(2):433-440. doi: 10.1016/j.clnu.2021.12.035. Epub 2021 Dec 28.
PubMed 35007812
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT05101889
- Acronym / sponsor ID
- REC.56-036-13-1-1
- Conditions
- Oral Mucositis
- Keywords
- head and neck cancer, nasopharyngeal cancer, immunonutrition, concurrent chemoradiation, survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 11 Jan 2013 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 1 Nov 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.
This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- phase II randomized, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition | Experimental | Dietary Supplement: Oral Impact®Oral immunomodulating formula (Oral Impact®, Nestle) One sachet of Oral Impact® consisted of 74 g of powder providing 303 kilocalories. Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session. |
| Control | Active comparator | Dietary Supplement: Oral Impact®An isocaloric isonitrogenous standard enteral nutrition formula. Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age of 18-65 years
- histological confirmation of stage II-IVb non-metastatic HNC according to the seventh edition of the American Joint Committee on Cancer Staging System (AJCC 2010)
- receipt of definitive CCRT
- Eastern Cooperative Oncology Group performance status of 0-1
- creatinine clearance ≥ 60 mL/min/1.73 m2 calculated by the Cockcroft-Gault formula
Key exclusion criteria (2 listed)
- receipt of curative surgery for HNC
- allergies to any component of the immunonutrition
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 Impact®Also: Blendera®3 ready-to-drink bottles/day | Dietary supplement | Control, Immunonutrition |
Primary outcome
Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria
Time frame: 6 weeks after initiation of concurrent chemoradiation (CCRT)
Proportion of severe oral mucositis between two groups
11 secondary outcomes
Other treatment-related toxicities graded according to the NCI CTCAE version 4.03 criteria
Time frame: through study completion, an average of 6 weeks
body weight in kilograms
Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
serum albumin in grams per deciliter (g/dL)
Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
hemoglobin in grams per deciliter (g/dL)
Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
C-reactive protein (CRP) in milligrams per liter (mg/L)
Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
neutrophil-to-lymphocyte ratio (NLR)
Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
platelet-to-lymphocyte ratio (PLR)
Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
actual dose of radiation in centigrays (cGy)
Time frame: through study completion, an average of 6 weeks
cumulative dose of cisplatin in milligrams per square meter (mg/m2)
Time frame: through study completion, an average of 6 weeks
progression-free survival (PFS)
Time frame: at 3 years
overall survival (OS)
Time frame: at 3 years
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 Nov 2021.
- Derived from this study: PubMed 35007812Dechaphunkul T, Arundon T, Raungkhajon P, Jiratrachu R, Geater SL, Dechaphunkul A. Benefits of immunonutrition in patients with head and neck cancer receiving chemoradiation: A phase II randomized, double-blind study. Clin Nutr. 2022 Feb;41(2):433-440. doi: 10.1016/j.clnu.2021.12.035. Epub 2021 Dec 28.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Impact® in people with Oral Mucositis, run by Prince of Songkla University.
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 7 inclusion and 2 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria (time frame: 6 weeks after initiation of concurrent chemoradiation (CCRT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05101889, which also lists 1 linked publication.
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 Nov 2021.