Squamous Cell Carcinoma of MouthIMPACTHNNCT01314755
A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer
A study testing IMPACT in people with Squamous Cell Carcinoma of Mouth and Squamous Cell Carcinoma of Oropharynx, run by Terrence Jones at 1 site in United Kingdom.
Trial summary
Study Hypothesis: The peri-operative enteral administration of a proprietary immune-enhancing feed (IMPACT) will not reduce post-operative infective complications in patients undergoing major surgery for squamous cell carcinoma of the Head and neck (SCCHN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Mouth, Squamous Cell Carcinoma of Oropharynx, Laryngeal Squamous Cell Carcinoma
- What is being tested?
- IMPACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2003to Jul 2008
- Phase
- Interventional
- 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
- Patients who were to undergo either of the following procedures
- partial (external approach) or total laryngectomy
- partial pharyngectomy with primary closure or free-flap reconstruction
- total pharyngectomy (gastric (or colonic) transposition, other free flap reconstruction, or other pedicled flap reconstruction)
- oral cavity or oropharyngeal resection requiring reconstruction with a free flap or pedicled flap
Who cannot join
- Patients with
- malabsorption syndromes
- primary immune disorders
- active infection on presentation
- patients undergoing secondary surgical reconstruction
- patients undergoing palliative surgery
- patients aged under 18 years old
- patients who were pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Aintree
Liverpool, Merseyside, L9 7AL
About this study
Official title: A Double Blind, Randomised, Placebo Controlled, Feasibility Phase III Clinical Trial of Peri-operative Immune-enhancing Feed in Patients Undergoing Surgery for Advanced Head and Neck Cancer
Study Hypothesis: The peri-operative enteral administration of a proprietary immune-enhancing feed (IMPACT) will not reduce post-operative infective complications in patients undergoing major surgery for squamous cell carcinoma of the Head and neck (SCCHN).
Patients who present with SCCHN for whom surgery is the recommended treatment will, assuming they fulfill the eligibility criteria, be block randomised into a two-group, double-blind randomised controlled trial. One group will receive IMPACT, the other an iso-caloric, iso-nitrogenous control feed for 5 days pre and 7 days post-operatively. In both groups patients will be fed enterally. The feeds will be prepared in identical bottles to facilitate blinding. Primary outcome measures include major systemic infection, whilst secondary outcome measures include local infection and length of hospital stay. Follow-up will be for 30 days postsurgery.
Read the detailed description
As above
- Conditions
- Squamous Cell Carcinoma of Mouth, Squamous Cell Carcinoma of Oropharynx, Laryngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Hypopharynx
- Being tested
- IMPACT, An iso-caloric, iso-nitrogenous control feed
- Keywords
- Head and Neck neoplasm, Nutrition, Carcinoma, Infection, Post-operative, Surgery, Immune-enhancing
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Carcinoma, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACTDietary supplement
IMPACT (Nestlé Healthcare Nutrition, Minnetonka, MN, 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.
An iso-caloric, iso-nitrogenous control feedDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| immune-enhancing feed IMPACT | Experimental | immune-enhancing feed IMPACT Receives: Dietary Supplement: IMPACT |
| control arm | Active comparator | iso-nitrogenous, iso-caloric control feed Receives: Dietary Supplement: An iso-caloric, iso-nitrogenous control feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic infection
Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.
Measured: 30 days post surgery
Secondary outcomes (2)
Local/wound site infection
Local/wound site infection
Measured: Within 30 days post-surgery
Length of post-operative hospital stay
Length of post-operative hospital stay
Measured: Up to 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startNov 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of MouthStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- either Impact or an iso-nitrogenous, iso-caloric control feed for five days pre and seven days post-surgery
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terrence Jones
- Sponsor type
- Other government
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor-investigator, Terrence Jones, Liverpool University Hospitals NHS Foundation Trust
- Investigators
- Terence M Jones, MD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314755
- Sponsor's protocol ID
- EC.73.03
- Acronym
- IMPACTHN
- Status last verified
- Aug 2020
- First submitted
- 14 Mar 2011
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomised, Placebo Controlled, Feasibility Phase III Clinical Trial of Peri-operative Immune-enhancing Feed in Patients Undergoing Surgery for Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01314755
- Acronym / sponsor ID
- IMPACTHN / EC.73.03
- Conditions
- Squamous Cell Carcinoma of Mouth, Squamous Cell Carcinoma of Oropharynx, Laryngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Hypopharynx
- Keywords
- Head and Neck neoplasm, Nutrition, Carcinoma, Infection, Post-operative, Surgery, Immune-enhancing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Terrence JonesOther government
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Nov 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Mar 2011 (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.
Study Hypothesis: The peri-operative enteral administration of a proprietary immune-enhancing feed (IMPACT) will not reduce post-operative infective complications in patients undergoing major surgery for squamous cell carcinoma of the Head and neck (SCCHN).
Patients who present with SCCHN for whom surgery is the recommended treatment will, assuming they fulfill the eligibility criteria, be block randomised into a two-group, double-blind randomised controlled trial. One group will receive IMPACT, the other an iso-caloric, iso-nitrogenous control feed for 5 days pre and 7 days post-operatively. In both groups patients will be fed enterally. The feeds will be prepared in identical bottles to facilitate blinding. Primary outcome measures include major systemic infection, whilst secondary outcome measures include local infection and length of hospital stay. Follow-up will be for 30 days postsurgery.
Detailed description
As above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- either Impact or an iso-nitrogenous, iso-caloric control feed for five days pre and seven days post-surgery
| Arm | Type | Receives |
|---|---|---|
| immune-enhancing feed IMPACT | Experimental | Dietary Supplement: IMPACTimmune-enhancing feed IMPACT |
| control arm | Active comparator | Dietary Supplement: An iso-caloric, iso-nitrogenous control feediso-nitrogenous, iso-caloric control feed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who were to undergo either of the following procedures
- partial (external approach) or total laryngectomy
- partial pharyngectomy with primary closure or free-flap reconstruction
- total pharyngectomy (gastric (or colonic) transposition, other free flap reconstruction, or other pedicled flap reconstruction)
- oral cavity or oropharyngeal resection requiring reconstruction with a free flap or pedicled flap
Key exclusion criteria (8 listed)
- Patients with
- malabsorption syndromes
- primary immune disorders
- active infection on presentation
- patients undergoing secondary surgical reconstruction
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 |
|---|---|---|
| IMPACTIMPACT (Nestlé Healthcare Nutrition, Minnetonka, MN, 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 | immune-enhancing feed IMPACT |
| An iso-caloric, iso-nitrogenous control feed | Dietary supplement | control arm |
Primary outcome
Systemic infection
Time frame: 30 days post surgery
Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.
2 secondary outcomes
Local/wound site infection
Time frame: Within 30 days post-surgery
Length of post-operative hospital stay
Time frame: Up to 30 days post surgery
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 Aug 2020.
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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.
Terence M Jones, MD principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT in people with Squamous Cell Carcinoma of Mouth and Squamous Cell Carcinoma of Oropharynx, run by Terrence Jones at 1 site in United Kingdom.
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 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 7 Aug 2020. 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 United Kingdom. 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.
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?
Systemic infection (time frame: 30 days post 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 Aug 2020.