Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

NCT03531190 | Completed DMC

• 1 other identifier: H-17040654
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer; wound healing; pre and post-surgical nutrition; zinc, arginine, vitamin C, protein, oral supplements

Outcome Measures

Primary Outcomes (1)

• POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)

  points on POSAS-questionaire (7-70)

  2 months

Secondary Outcomes (4)

• Appearance of the scar (scale)

  2 months

• Ultrasound scanning

  2 months

• Biochemical measurements (micromol/l) at start and finish

  2 months

• Size of the scar (cm)

  2 months

Other Outcomes (2)

• Peripheral oxygen tension (partial pressure, kPa)

  2 months

• Difficulty in swallowing (scale)

  2 months

Study Arms (2)

Nutritional supplement (Protein + MIX)

EXPERIMENTAL

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 (Protein)

ACTIVE COMPARATOR

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

Dietary Supplement: Nutritional supplement (Protein)

Interventions

Nutritional supplement (Protein + MIX) 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 + MIX)

Nutritional supplement (Protein) DIETARY_SUPPLEMENT

Protein supplement as needed

Nutritional supplement (Protein)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Copenhagen: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Dietary Supplements; Proteins

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Amino Acids, Peptides, and Proteins

Study Officials

• Jens Rikardt R Andersen, MD,MPA

  University of Copenhagen, Department of Nutrition, Exercise and Sports

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized to intervention. Control is the present treatment in the department + protein supplementation

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 21, 2018
• Study Start: May 10, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)