Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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The purpose of the project is to investigate the effect of wound healing of a combined pre- and postoperative oral supplement, consisting of zinc, vitamin C, arginine and multivitamin, as a supplement for adequate nutrition in patients operated for head and neck cancer.

Detailed Description
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The project will be conducted as an open, randomized intervention study, and includes patients with head and neck cancer that are planned for operation. 40 participants are allocated to the intervention or control group, respectively. For both groups, the experiment will last for five to six weeks, depending on when the trial participants are planned for surgery. The intervention group must take a dietary supplement and a protein drink for 35 days (7 days preoperatively and 28 days postoperatively), which is delivered 7 days preoperatively. The same applies to the control group that only receives protein drinks. The length of the intervention period is based on the design of previous studies. During the project, compliance will be evaluated by counting the amount of remaining dietary supplements and protein drinks that the participants return on a regular basis. The control group receives standard treatment as well as protein drinks. For all participants included in the experiment blood tests and an ultrasound scanning will be performed.

Official Title
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A Randomized Controlled Clinical Trial of Pre- and Postoperative Supplementation With Zinc, Vitamin C, Arginine and Multivitamin Mineral in Patients Treated for Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Dietary Supplement: Nutritional supplement (Protein + MIX)
* Dietary Supplement: Nutritional supplement (Protein)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Authorized/legal age (> 18 years) Patients who understand written and oral Danish, and are able to give written consent Patients diagnosed with head and neck cancer, which are set for surgery Patients operated on the outside of the neck Exclusion Criteria: Patients who do not understand, speak or write Danish Not Authorized/not legal age (<18 years) Pregnant and breastfeeding women Patients previously employed in the field of surgery within the last 5 years (prior years)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized to intervention. Control is the present treatment in the department + protein supplementation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional supplement (Protein + MIX)<br>Patients are given: Nutritional Supplement of protein 2-3 times a day + MIX once daily for 35 days | Dietary Supplement: Nutritional supplement (Protein + MIX)<br>* Protein supplement as needed + 750 mg vitamin C, 15 g. arginine, 35 mg. zinc and two multivitamin tablets, by mouth every day for 35 days.<br>|
| Active Comparator: Nutritional supplement (Protein)<br>Nutritional Supplement of protein as needed 2-3 times a day for 35 days | Dietary Supplement: Nutritional supplement (Protein)<br>* Protein supplement as needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN) | points on POSAS-questionaire (7-70) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of the scar (scale) | blind professional rating based on rank (from photographs)(1-10) | 2 months | 
| Ultrasound scanning | Number of cavities in the wound | 2 months | 
| Biochemical measurements (micromol/l) at start and finish | Changes in the concentrations of micronutrients in the intervention period: p-albumin, p-C-Reactive Protein, p-cobalamin, p-folic acid, p-magnesium, p-ferritin | 2 months | 
| Size of the scar (cm) | measured with ruler | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck cancer, wound healing, pre and post-surgical nutrition, zinc, arginine, vitamin C, protein, oral supplements