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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- University of Copenhagen
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Jens Rikardt Andersen
Associate Professor
University of Copenhagen
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)
Outcomes
Primary Outcomes
POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)
Time Frame: 2 months
points on POSAS-questionaire (7-70)
Secondary Outcomes
- Ultrasound scanning(2 months)
- Appearance of the scar (scale)(2 months)
- Size of the scar (cm)(2 months)
- Biochemical measurements (micromol/l) at start and finish(2 months)