Head and Neck NeoplasmsPhase 4NCT02622880
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients
A Phase 4 study testing immunomodulatory supplement and IMPACT in people with Head and Neck Neoplasms, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days before surgery , on the number and characteristics of postoperative infections for a period of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell cancer patients, candidates for surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- immunomodulatory supplement and IMPACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Jun 2014
- 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
- Men and women >18 years
- Patients with histologically confirmed squamous cell cancer of the oropharynx, hypopharynx , larynx and oral cavity and candidates for neoplastic surgery (undergoing surgery)
- Adequate cultural level and understanding for the clinical trial. and agree to participate voluntarily in the study and give written informed consent
- Patients who do not participate in other clinical trials
Who cannot join
- Patients with an active infectious process at the time of the study.
- Patients who have undergone radiotherapy / chemotherapy prior to surgery.
- Subjects diagnosed with Type I Diabetes Mellitus
- Subjects who used oral hypoglycemic agents or insulin.
- Patients with severe kidney disease, heart, respiratory or liver.
- Patients with autoimmune diseases or immunosuppressive drugs used.
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- Subjects with dementia, mental illness or diminished cognitive function.
- Subjects who refuse oral supplements.
- Subjects who consume vitamin supplements or artificial nutrition, and which can not be suspended at least 1 week before the study and do not accept to suspend it during the study.
- Subjects with morbid obesity (BMI ≥ 40 kg / m2).
- Pregnant or breastfeeding
- Patients diagnosed with epidermoid carcinoma T1 glottic, cordectomy candidate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery
The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days before surgery , on the number and characteristics of postoperative infections for a period of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell cancer patients, candidates for surgery.
Read the detailed description
68 subjects randomized into two study groups: 34 subjects consume the supplement of the study and 34 control consume the supplement IMPACT.
Intervention period will be 10 days before surgery . The consume amount is 400 ml/ day. The Subjects were stratified according to tumor location ( larynx and oral cavity and oropharynx, hypopharynx) and disease stage (early and advanced).
- Conditions
- Head and Neck Neoplasms
- Being tested
- immunomodulatory supplement, IMPACT
- 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.
immunomodulatory supplementDietary supplement
Experimental Group (immunomodulatory supplement STUDY)
IMPACTDietary supplement
IMPACT (Nestle Healthcare Nutrition, Minnesota USA) an 'immune-enhancing' feed which contains supplemental L-arginine (1.25 78 g/L), dietary nucleotides (1.2 g/L) and omega-3 fatty acids in the form of 79 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (EPA/DHA 1.7 g/L) 80 as its active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| : IMPACT | Active comparator | along 10 days before surgery Receives: Dietary Supplement: IMPACT |
| immunomodulatory supplement | Experimental | along 10 days before surgery Receives: Dietary Supplement: immunomodulatory supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of postoperative infections
Measured: 30 days after surgery
Secondary outcomes (10)
Change from baseline Retinol-binding protein
Measured: 0 and 30 days
Length of post-operative hospital stay
Measured: through study completion, an average of 3 months
Mortality
Measured: through study completion, an average of 3 months
change from baseline C-reactive protein
Measured: 0 and 30 days
change from baseline albumin
Measured: 0 and 30 days
change from baseline transferrin
Measured: 0 and 30 days
change from baseline prealbumin
Measured: 0 and 30 days
change from baseline Bioelectrical impedance analysis
Measured: 0 and 30 days
change from baseline leukocytes
Measured: 0 and 30 days
change from baseline Fibrinogen
Measured: 0 and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Vegenat, S.A.
- Responsible party
- Sponsor
- Investigators
- Carmen Gomez Candela, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622880
- Sponsor's protocol ID
- VEGENAT
- Status last verified
- Dec 2015
- First submitted
- 24 Nov 2015
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery
- ClinicalTrials.gov ID
- NCT02622880
- Acronym / sponsor ID
- VEGENAT
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Vegenat, S.A.
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Dec 2015 (estimated)
- 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.
The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days before surgery , on the number and characteristics of postoperative infections for a period of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell cancer patients, candidates for surgery.
Detailed description
68 subjects randomized into two study groups: 34 subjects consume the supplement of the study and 34 control consume the supplement IMPACT.
Intervention period will be 10 days before surgery . The consume amount is 400 ml/ day. The Subjects were stratified according to tumor location ( larynx and oral cavity and oropharynx, hypopharynx) and disease stage (early and advanced).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| : IMPACT | Active comparator | Dietary Supplement: IMPACTalong 10 days before surgery |
| immunomodulatory supplement | Experimental | Dietary Supplement: immunomodulatory supplementalong 10 days before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women >18 years
- Patients with histologically confirmed squamous cell cancer of the oropharynx, hypopharynx , larynx and oral cavity and candidates for neoplastic surgery (undergoing surgery)
- Adequate cultural level and understanding for the clinical trial. and agree to participate voluntarily in the study and give written informed consent
- Patients who do not participate in other clinical trials
Key exclusion criteria (12 listed)
- Patients with an active infectious process at the time of the study.
- Patients who have undergone radiotherapy / chemotherapy prior to surgery.
- Subjects diagnosed with Type I Diabetes Mellitus
- Subjects who used oral hypoglycemic agents or insulin.
- Patients with severe kidney disease, heart, respiratory or liver.
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 |
|---|---|---|
| immunomodulatory supplementExperimental Group (immunomodulatory supplement STUDY) | Dietary supplement | immunomodulatory supplement |
| IMPACTIMPACT (Nestle Healthcare Nutrition, Minnesota USA) an 'immune-enhancing' feed which contains supplemental L-arginine (1.25 78 g/L), dietary nucleotides (1.2 g/L) and omega-3 fatty acids in the form of 79 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (EPA/DHA 1.7 g/L) 80 as its active ingredients. | Dietary supplement | : IMPACT |
Primary outcome
Number of postoperative infections
Time frame: 30 days after surgery
10 secondary outcomes
Change from baseline Retinol-binding protein
Time frame: 0 and 30 days
Length of post-operative hospital stay
Time frame: through study completion, an average of 3 months
Mortality
Time frame: through study completion, an average of 3 months
change from baseline C-reactive protein
Time frame: 0 and 30 days
change from baseline albumin
Time frame: 0 and 30 days
change from baseline transferrin
Time frame: 0 and 30 days
change from baseline prealbumin
Time frame: 0 and 30 days
change from baseline Bioelectrical impedance analysis
Time frame: 0 and 30 days
change from baseline leukocytes
Time frame: 0 and 30 days
change from baseline Fibrinogen
Time frame: 0 and 30 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 7 Dec 2015.
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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.
Carmen Gomez Candela principal investigator
Hospital Universitario La Paz
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 immunomodulatory supplement and IMPACT in people with Head and Neck Neoplasms, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 4 inclusion and 12 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 7 Dec 2015. 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 Spain. 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 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?
Number of postoperative infections (time frame: 30 days after surgery). 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 7 Dec 2015.