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Completed

NCT Number: NCT03531190

Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Dietary Supplement

Protein supplement as needed

Primary outcomes

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

    Time frame: 2 months

    points on POSAS-questionaire (7-70)

Secondary outcomes

  1. Appearance of the scar (scale)

    Time frame: 2 months

    blind professional rating based on rank (from photographs)(1-10)

  2. Ultrasound scanning

    Time frame: 2 months

    Number of cavities in the wound

  3. Biochemical measurements (micromol/l) at start and finish

    Time frame: 2 months

    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

  4. Size of the scar (cm)

    Time frame: 2 months

    measured with ruler

Other outcomes

  1. Peripheral oxygen tension (partial pressure, kPa)

    Time frame: 2 months

    Peripheral oxygen tension measured on the finger tip

  2. Difficulty in swallowing (scale)

    Time frame: 2 months

    assessed by rank-scale (1-100)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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