Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT03531190
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Protein supplement as needed
Time frame: 2 months
points on POSAS-questionaire (7-70)
Time frame: 2 months
blind professional rating based on rank (from photographs)(1-10)
Time frame: 2 months
Number of cavities in the wound
Time frame: 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
Time frame: 2 months
measured with ruler
Time frame: 2 months
Peripheral oxygen tension measured on the finger tip
Time frame: 2 months
assessed by rank-scale (1-100)
University of Copenhagen
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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