Clinical trial · Interventional
Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer
Perioperative Nutritional Optimization in Head and Neck Cancer Patients
NCT03261180CI-TRIAL-00043642withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Nutritional Intervention | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (Nestle Impact AR)
- description
- Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Dietary Supplement: Nutritional Intervention
- type
- ACTIVE_COMPARATOR
- label
- Group II (regular diet)
- description
- Patients receive regular diet.
- interventionNames
- Other: Best Practice
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Rate of post-operative wound complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.