Clinical trial NCT03531190: Pre- and Postoperative Nutrition in Head and Neck Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and neck cancer
wound healing
pre and post-surgical nutrition
zinc, arginine, vitamin C, protein, oral supplements
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2018-05-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to intervention. Control is the present treatment in the department + protein supplementation
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)
timeFrame: 2 months
Secondary outcomes:
measure: Appearance of the scar (scale)
timeFrame: 2 months
measure: Ultrasound scanning
timeFrame: 2 months
measure: Biochemical measurements (micromol/l) at start and finish
timeFrame: 2 months
measure: Size of the scar (cm)
timeFrame: 2 months
Other outcomes:
measure: Peripheral oxygen tension (partial pressure, kPa)
timeFrame: 2 months
measure: Difficulty in swallowing (scale)
timeFrame: 2 months
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: University of Copenhagen, Department of Nutrition, Exercise and Sports
name: Jens Rikardt R Andersen, MD,MPA
role: PRINCIPAL_INVESTIGATOR
References: