Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

University of Copenhagen

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Dietary Supplement: Nutritional supplement (Protein); Dietary Supplement: Nutritional supplement (Protein + MIX)

Study type: Interventional

Funder types: Other

Identifiers

NCT03531190

H-17040654

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Nutritional supplement (Protein + MIX)

Experimental group

Description:

Patients are given: Nutritional Supplement of protein 2-3 times a day + MIX once daily for 35 days

Treatment:

Dietary Supplement: Nutritional supplement (Protein + MIX)

Nutritional supplement (Protein)

Active Comparator group

Description:

Nutritional Supplement of protein as needed 2-3 times a day for 35 days

Treatment:

Dietary Supplement: Nutritional supplement (Protein)