Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Dietary Supplement: Nutritional supplement (Protein); Dietary Supplement: Nutritional supplement (Protein + MIX)

• Registration Number: NCT03531190
• Lead Sponsor: University of Copenhagen

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-04-09
• Study Start: 2018-05-10
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-21
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional supplement (Protein)	Nutritional supplement (Protein)	Nutritional Supplement of protein as needed 2-3 times a day for 35 days
Nutritional supplement (Protein + MIX)	Nutritional supplement (Protein + MIX)	Patients are given: Nutritional Supplement of protein 2-3 times a day + MIX once daily for 35 days

Primary Outcome Measures

Name	Time	Method
POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)	2 months	points on POSAS-questionaire (7-70)

Secondary Outcome Measures

Name	Time	Method
Ultrasound scanning	2 months	Number of cavities in the wound
Appearance of the scar (scale)	2 months	blind professional rating based on rank (from photographs)(1-10)
Size of the scar (cm)	2 months	measured with ruler
Biochemical measurements (micromol/l) at start and finish	2 months	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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark