Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

NCT ID: NCT03531190

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-10
• Study Completion Date: 2018-11-30

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nutritional supplement (Protein + MIX)

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

Group Type: EXPERIMENTAL

Nutritional supplement (Protein + MIX)

Intervention Type: DIETARY_SUPPLEMENT

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)

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

Group Type: ACTIVE_COMPARATOR

Nutritional supplement (Protein)

Intervention Type: DIETARY_SUPPLEMENT

Protein supplement as needed

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Nutritional supplement (Protein)

Protein supplement as needed

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Rikardt R Andersen, MD,MPA

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen, Department of Nutrition, Exercise and Sports

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-17040654

Identifier Type: -

Identifier Source: org_study_id