Head and Neck CarcinomaNCT03261180
Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer
A study testing Best Practice, Laboratory Biomarker Analysis and Nutritional Intervention in people with Head and Neck Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in improving surgery recovery in patients with head and neck cancer. Adding a nutritional supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head and neck cancer surgery may help to decrease the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Best Practice, Laboratory Biomarker Analysis and Nutritional Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 9 Aug 2021
- 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
- Members of all races and ethnic groups will be included
- Patients must be diagnosed with cancer of the head and neck and must be surgical candidates
- Patients must be indicated for major head and neck surgery, defined as surgeries with an anticipated post-surgical hospital stay of 4 or more days; examples of major surgeries include, but are not limited to, total laryngectomy, large oral cavity, oropharyngeal, salivary gland, or soft tissue resections requiring free flap or major regional flap (e.g. pectoralis major flap), and large skull base procedures requiring extensive skull base reconstruction
- Patients must have cross-sectional body imaging (positron emission tomography [PET]-computed tomography [CT] or equivalent) performed within 4 weeks of study enrollment and available for review
- Patient must be willing to receive Nestle IMPACT Advance Recovery for five days prior to planned surgery as well as for 5 days after surgery
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with known distant metastases or other malignancies
- Patients unable to tolerate oral intake by mouth or per enteral feeding tube
- Patients with galactosemia
- Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
- Patients currently taking IMPACT or other immunonutrition products (arginine-containing supplements) will be excluded; other forms of nutritional supplementation, such as caloric supplementation, tube feeding, or other dietary supplements are allowed on study
- Patients currently taking anabolic steroids will be excluded; patients taking corticosteroids are allowed on study
- Psychiatric illness/social situations that would limit compliance with study requirements
- Excluded patients will be allowed to participate in the trial on an observational basis only
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Perioperative Nutritional Optimization in Head and Neck Cancer Patients
This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in improving surgery recovery in patients with head and neck cancer. Adding a nutritional supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head and neck cancer surgery may help to decrease the number of wound complications after surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the effect of perioperative use of Nestle Impact Advanced Recovery (AR) on the rate of post-operative wound complications within 30 days after major head and neck surgery.
SECONDARY OBJECTIVES:
- Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications.
II. Assess whether Nestle IMPACT AR decreases the rate of other post-operative complications such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile colitis within 30 days of surgery, as well as length of hospital stay.
TERTIARY OBJECTIVES:
- Assess changes in muscle metabolic gene expression at the time of surgery associated with sarcopenia and IMAPCT treatment.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet.
GROUP I: Patients receive regular diet.
After completion of study, patients are followed up for 30 days post-surgery.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Best Practice, Laboratory Biomarker Analysis, Nutritional Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive regular diet
Laboratory Biomarker AnalysisOther
Correlative studies
Nutritional InterventionDietary supplement
Receive Nestle Impact AR
| Study group | Role | What they receive |
|---|---|---|
| Group I (Nestle Impact AR) | Experimental | Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet. Receives: Other: Laboratory Biomarker Analysis; Dietary Supplement: Nutritional Intervention |
| Group II (regular diet) | Active comparator | Patients receive regular diet. Receives: Other: Best Practice; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative wound complications
A patient is found to have a post-operative complication is one of the following is observed: wound infection, seroma, wound dehiscence, fistula formation, free tissue flap loss. A 2-sided 95% confidence interval will also be calculated for each arm, using exact methods, and chi square testing will be performed to compare the incidence of wound complications within 30 days after surgery between control and experimental groups. A multivariate analysis of the primary endpoint will be performed with logistic regression to include study treatment, presence of sarcopenia, prior radiation therapy, a
Measured: Within 30 days after major head and neck surgery
Secondary outcomes (2)
Rate of other post-operative complications
Will assess whether Nestle IMPACT Advanced Recovery (AR) decreases the rate of other post-operative complications within 30 days after surgery such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile colitis as well as length of hospital stay. Will be analyzed using chi square testing. The analysis of the length of the stay (LOS) for patients in each arm will be analyzed using the Kaplan Meier method for estimation of summary statistics including the 25th, 50th (median), and 75th percentiles and associated 95% confidence intervals. Patients that die prior to
Measured: Within 30 days after surgery
Sarcopenia
Will assess whether sarcopenia is an independent risk factor for the development of 30-day post-operative wound complications. Will be analyzed using chi square testing.
Measured: Within 30 days after major head and neck surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start30 Nov 2017
- Primary completion10 Aug 2020 (estimated)
- Study completion9 Aug 2021 (estimated)
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Daniel Clayburgh, OHSU Knight Cancer Institute
- Investigators
- Daniel Clayburgh, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261180
- Sponsor's protocol ID
- STUDY00015929
- Other IDs
- NCI-2017-01480, IRB00015929, P30CA069533
- Status last verified
- Feb 2020
- First submitted
- 22 Aug 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Nutritional Optimization in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT03261180
- Acronym / sponsor ID
- STUDY00015929
- Conditions
- Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 10 Aug 2020 (estimated)
- Study completion
- 9 Aug 2021 (estimated)
- First posted
- 24 Aug 2017 (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 randomized clinical trial studies how well Nestle Impact Advanced Recovery works in improving surgery recovery in patients with head and neck cancer. Adding a nutritional supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head and neck cancer surgery may help to decrease the number of wound complications after surgery.
Detailed description
PRIMARY OBJECTIVES:
- Assess the effect of perioperative use of Nestle Impact Advanced Recovery (AR) on the rate of post-operative wound complications within 30 days after major head and neck surgery.
SECONDARY OBJECTIVES:
- Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications.
II. Assess whether Nestle IMPACT AR decreases the rate of other post-operative complications such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile colitis within 30 days of surgery, as well as length of hospital stay.
TERTIARY OBJECTIVES:
- Assess changes in muscle metabolic gene expression at the time of surgery associated with sarcopenia and IMAPCT treatment.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet.
GROUP I: Patients receive regular diet.
After completion of study, patients are followed up for 30 days post-surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Nestle Impact AR) | Experimental | Other: Laboratory Biomarker Analysis, Dietary Supplement: Nutritional InterventionPatients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet. |
| Group II (regular diet) | Active comparator | Other: Best Practice, Other: Laboratory Biomarker AnalysisPatients receive regular diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Members of all races and ethnic groups will be included
- Patients must be diagnosed with cancer of the head and neck and must be surgical candidates
- Patients must be indicated for major head and neck surgery, defined as surgeries with an anticipated post-surgical hospital stay of 4 or more days; examples of major surgeries include, but are not limited to, total laryngectomy, large oral cavity, oropharyngeal, salivary gland, or soft tissue resections requiring free flap or major regional flap (e.g. pectoralis major flap), and large skull base procedures requiring extensive skull base reconstruction
- Patients must have cross-sectional body imaging (positron emission tomography [PET]-computed tomography [CT] or equivalent) performed within 4 weeks of study enrollment and available for review
- Patient must be willing to receive Nestle IMPACT Advance Recovery for five days prior to planned surgery as well as for 5 days after surgery
Key exclusion criteria (8 listed)
- Patients with known distant metastases or other malignancies
- Patients unable to tolerate oral intake by mouth or per enteral feeding tube
- Patients with galactosemia
- Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
- Patients currently taking IMPACT or other immunonutrition products (arginine-containing supplements) will be excluded; other forms of nutritional supplementation, such as caloric supplementation, tube feeding, or other dietary supplements are allowed on 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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive regular diet | Other | Group II (regular diet) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (Nestle Impact AR), Group II (regular diet) |
| Nutritional InterventionReceive Nestle Impact AR | Dietary supplement | Group I (Nestle Impact AR) |
Primary outcome
Rate of post-operative wound complications
Time frame: Within 30 days after major head and neck surgery
A patient is found to have a post-operative complication is one of the following is observed: wound infection, seroma, wound dehiscence, fistula formation, free tissue flap loss. A 2-sided 95% confidence interval will also be calculated for each arm, using exact methods, and chi square testing will be performed to compare the incidence of wound complications within 30 days after surgery between control and experimental groups. A multivariate analysis of the primary endpoint will be performed with logistic regression to include study treatment, presence of sarcopenia, prior radiation therapy, a
2 secondary outcomes
Rate of other post-operative complications
Time frame: Within 30 days after surgery
Sarcopenia
Time frame: Within 30 days after major head and neck surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 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.
Daniel Clayburgh principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Laboratory Biomarker Analysis and Nutritional Intervention in people with Head and Neck Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
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 6 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: withdrawn, as of the sponsor's last update on 25 Feb 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of post-operative wound complications (time frame: Within 30 days after major head and neck 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 25 Feb 2020.