Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531190
• Other study ID #: H-17040654
• Status: Completed
• Phase: N/A
• Start date: May 10, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: September 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.
• Nutritional supplement (Protein)
Protein supplement as needed

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peripheral oxygen tension (partial pressure, kPa)	Peripheral oxygen tension measured on the finger tip	2 months
Other	Difficulty in swallowing (scale)	assessed by rank-scale (1-100)	2 months
Primary	POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)	points on POSAS-questionaire (7-70)	2 months
Secondary	Appearance of the scar (scale)	blind professional rating based on rank (from photographs)(1-10)	2 months
Secondary	Ultrasound scanning	Number of cavities in the wound	2 months
Secondary	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
Secondary	Size of the scar (cm)	measured with ruler	2 months