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Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nutritional supplement (Protein + MIX)
Nutritional supplement (Protein)
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and neck cancer, wound healing, pre and post-surgical nutrition, zinc, arginine, vitamin C, protein, oral supplements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nutritional supplement (Protein + MIX)

Nutritional supplement (Protein)

Arm Description

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

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

Outcomes

Primary Outcome Measures

POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)
points on POSAS-questionaire (7-70)

Secondary Outcome Measures

Appearance of the scar (scale)
blind professional rating based on rank (from photographs)(1-10)
Ultrasound scanning
Number of cavities in the wound
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
Size of the scar (cm)
measured with ruler

Full Information

First Posted
April 9, 2018
Last Updated
September 24, 2019
Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03531190
Brief Title
Pre- and Postoperative Nutrition in Head and Neck Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and neck cancer, wound healing, pre and post-surgical nutrition, zinc, arginine, vitamin C, protein, oral supplements

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized to intervention. Control is the present treatment in the department + protein supplementation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional supplement (Protein + MIX)
Arm Type
Experimental
Arm Description
Patients are given: Nutritional Supplement of protein 2-3 times a day + MIX once daily for 35 days
Arm Title
Nutritional supplement (Protein)
Arm Type
Active Comparator
Arm Description
Nutritional Supplement of protein as needed 2-3 times a day for 35 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplement (Protein + MIX)
Intervention Description
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
Intervention Name(s)
Nutritional supplement (Protein)
Intervention Description
Protein supplement as needed
Primary Outcome Measure Information:
Title
POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)
Description
points on POSAS-questionaire (7-70)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Appearance of the scar (scale)
Description
blind professional rating based on rank (from photographs)(1-10)
Time Frame
2 months
Title
Ultrasound scanning
Description
Number of cavities in the wound
Time Frame
2 months
Title
Biochemical measurements (micromol/l) at start and finish
Description
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
Time Frame
2 months
Title
Size of the scar (cm)
Description
measured with ruler
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Peripheral oxygen tension (partial pressure, kPa)
Description
Peripheral oxygen tension measured on the finger tip
Time Frame
2 months
Title
Difficulty in swallowing (scale)
Description
assessed by rank-scale (1-100)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Rikardt R Andersen, MD,MPA
Organizational Affiliation
University of Copenhagen, Department of Nutrition, Exercise and Sports
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Pre- and Postoperative Nutrition in Head and Neck Cancer Patients

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