Head and Neck CancerNCT03531190
Pre- and Postoperative Nutrition in Head and Neck Cancer Patients
A study testing Nutritional supplement (Protein + MIX) and Nutritional supplement (Protein) in people with Head and Neck Cancer, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Nutritional supplement (Protein + MIX) and Nutritional supplement (Protein)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 10 May 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Nutritional supplement (Protein + MIX), Nutritional supplement (Protein)
- Keywords
- Head and neck cancer, wound healing, pre and post-surgical nutrition, zinc, arginine, vitamin C, protein, oral supplements
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplement (Protein + MIX) | Experimental | Patients are given: Nutritional Supplement of protein 2-3 times a day + MIX once daily for 35 days Receives: 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 Receives: Dietary Supplement: Nutritional supplement (Protein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)
points on POSAS-questionaire (7-70)
Measured: 2 months
Secondary outcomes (4)
Appearance of the scar (scale)
blind professional rating based on rank (from photographs)(1-10)
Measured: 2 months
Ultrasound scanning
Number of cavities in the wound
Measured: 2 months
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
Measured: 2 months
Size of the scar (cm)
measured with ruler
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start10 May 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to intervention. Control is the present treatment in the department + protein supplementation
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens Rikardt R Andersen, MD,MPA, Principal investigator, University of Copenhagen, Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531190
- Sponsor's protocol ID
- H-17040654
- Status last verified
- Sep 2019
- First submitted
- 9 Apr 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03531190
- Acronym / sponsor ID
- H-17040654
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer, wound healing, pre and post-surgical nutrition, zinc, arginine, vitamin C, protein, oral supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 10 May 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized to intervention. Control is the present treatment in the department + protein supplementation
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplement (Protein + MIX) | Experimental | Dietary Supplement: Nutritional supplement (Protein + MIX)Patients are given: Nutritional Supplement of protein 2-3 times a day + MIX once daily for 35 days |
| Nutritional supplement (Protein) | Active comparator | Dietary Supplement: Nutritional supplement (Protein)Nutritional Supplement of protein as needed 2-3 times a day for 35 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Nutritional supplement (Protein + MIX) |
| Nutritional supplement (Protein)Protein supplement as needed | Dietary supplement | Nutritional supplement (Protein) |
Primary outcome
POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)
Time frame: 2 months
points on POSAS-questionaire (7-70)
4 secondary outcomes
Appearance of the scar (scale)
Time frame: 2 months
Ultrasound scanning
Time frame: 2 months
Biochemical measurements (micromol/l) at start and finish
Time frame: 2 months
Size of the scar (cm)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Rikardt R Andersen, MD,MPA principal investigator
University of Copenhagen, Department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplement (Protein + MIX) and Nutritional supplement (Protein) in people with Head and Neck Cancer, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.