An interventional study of Nutritional supplement (Protein + MIX) and Nutritional supplement (Protein) in Head and Neck Cancer, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Treatment
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 42 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Patients are given: Nutritional Supplement of protein 2-3 times a day + MIX once daily for 35 days
Dietary Supplement: Nutritional supplement (Protein + MIX)
Nutritional Supplement of protein as needed 2-3 times a day for 35 days
Dietary Supplement: Nutritional supplement (Protein)
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
POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)
points on POSAS-questionaire (7-70)
Time frame: 2 months
Appearance of the scar (scale)
blind professional rating based on rank (from photographs)(1-10)
Time frame: 2 months
Ultrasound scanning
Number of cavities in the wound
Time frame: 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
Time frame: 2 months
Size of the scar (cm)
measured with ruler
Time frame: 2 months
Peripheral oxygen tension (partial pressure, kPa)
Peripheral oxygen tension measured on the finger tip
Time frame: 2 months
Difficulty in swallowing (scale)
assessed by rank-scale (1-100)
Time frame: 2 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of Copenhagen