Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Dietary supplement: Nutritional supplement (Protein + MIX); Dietary supplement: Nutritional supplement (Protein)

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional supplement (Protein + MIX); Patients are given: Nutritional Supplement of protein 2-3 times a day + MIX once daily for 35 days	Dietary supplement: Nutritional supplement (Protein + MIX); 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.
Active Comparator: Nutritional supplement (Protein); Nutritional Supplement of protein as needed 2-3 times a day for 35 days	Dietary supplement: Nutritional supplement (Protein); Protein supplement as needed

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral oxygen tension (partial pressure, kPa)	Peripheral oxygen tension measured on the finger tip	2 months
Difficulty in swallowing (scale)	assessed by rank-scale (1-100)	2 months

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Jens Rikardt R Andersen, MD,MPA, University of Copenhagen, Department of Nutrition, Exercise and Sports

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: wound healing; Head and neck cancer; pre and post-surgical nutrition; zinc, arginine, vitamin C, protein, oral supplements
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: H-17040654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No