Head and Neck CancerNCT03909256
NUTRI-HAB - Posttreatment Rehabilitation of Nutrition Impact Symptoms in Head and Neck Cancer Survivors
A study testing NUTRI-HAB in people with Head and Neck Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The study is a randomised controlled trial that aims to test the effect of a residential rehabilitation program with a focus on eating problems after treatment in head and neck cancer survivors. 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?
- NUTRI-HAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Apr 2019to 9 Dec 2019
- 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
- Cancer of the larynx, pharynx or oral cavity
- Treatment with radiation therapy completed 1-5 years before inclusion
- Curatively treated
- Expression of interest in participating in the rehabilitation program in a preceding survey
- Self-reliant and no need for assistance with personal hygiene etc.
Who cannot join
- Active cancer disease at the time of recruitment
- Not being able to speak and understand Danish
- No permanent residence in Denmark
Trial locations and contacts
1 site in 1 country.
Denmark1 site
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Nyborg, 5800
About this study
Official title: NUTRI-HAB - A Randomised Controlled Trial on the Effect of a Targeted Residential Rehabilitation Program With a Focus on Eating Problems After Treatment for Head and Neck Cancer
The study is a randomised controlled trial that aims to test the effect of a residential rehabilitation program with a focus on eating problems after treatment in head and neck cancer survivors. The study will furthermore investigate whether selected nutrition screening and assessment tools can be used to identify head and neck cancer survivor who benefit from the program.
Read the detailed description
This study is a randomised controlled trial with following objectives:
- To test the effect of a targeted residential rehabilitation program with focus on the physical, psychological and social aspects of eating problems on body weight, health-related quality of life and physical function in curatively treated head and neck cancer survivors 1-5 years after completion of radiation therapy
- To test whether a potential effect of the program is associated with/dependent of the participants' score in Scores Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF), Nutrition Risk Screening 2002 (NRS 2002) or M.D. Anderson Dysphagia Inventory (MDADI) at baseline
- Conditions
- Head and Neck Cancer
- Being tested
- NUTRI-HAB
- Keywords
- Rehabilitation, Nutrition impact symptoms, Quality of life
- 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.
NUTRI-HABOther
The rehabilitation program is a coordinated multidisciplinary effort involving several specialists e.g. clinical dietitians, nurses, physiotherapists, occupational therapists (responsible for dysphagia management in Denmark), psychologists and social workers.
The program includes group sessions with patient education on how to handle the different aspects of living with eating problems and other late effects. Practical kitchen exercises, physical activity sessions and instruction in swallowing training are included. Individual counseling sessions with clinical dietitians and other health professionals (e.g. physicians) are offered depending on participants' needs.
Participants stay at the premises and all meals throughout the day are served in the dining room or in the café. Foods of different textures and flavors are served to inspire participants and to allow them to experiment.
Between the initial stay and follow-up participants are contacted twice by a clinical dietitian.
| Study group | Role | What they receive |
|---|---|---|
| NUTRI-HAB | Experimental | The intervention group participates in a targeted rehabilitation program 'NUTRI-HAB' with a focus on eating problem after treatment for head and neck cancer. The program comprises:
* a five day residential stay with patient education
* a two day follow-up residential stay after 3 months
* two telephone consultations with clinical dietitian between the two residential stays. Receives: Other: NUTRI-HAB |
| Control group | No intervention | The control group receives no intervention other than usual care in the study period. After 3 months, the control group will be offered participation in the same residential rehabilitation program as the intervention group parcitipated in. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline to follow up
Body weight will be measured with a calibrated scale at baseline and at follow up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant and be used as the primary outcome.
Measured: Difference between measurements at baseline and at follow-up after 3 and 6 months
Secondary outcomes (8)
Change in health-related quality of life (EORTC QLQ-C30) from baseline to follow up
Health-related quality of life (QOL) is measured using the generic EORTC QLQ-C30 questionnaire for cancer patients. Questionnaires will be scored according to EORTC's scoring manual, and changes from baseline to follow-up in the QOL-subscales will be calculated for each individual participant.
The questionnaire consist of 30 items that are further divided into 15 subscales/items: a global health status/QOL scale; the functional scales: physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and the symptom scales/items: fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties.
All scales and single-item measures range in score from 0 to 100. A high score represents a higher response level. Thus a high score for a functional scale or global QOL represents a high level of functioning/QOL whereas a high score on a symptom scale represents a high level of symptoms.
Measured: Difference between measurements at baseline and at follow-up after 3 and 6 months
Change in health-related quality of life (EORTC QLQ-H&N35) from baseline to follow up
Health-related quality of life (QOL) is measured using the questionnaire EORTC QLQ-H\&N35 specific for head and neck cancer. Questionnaires will be scored according to EORTC's scoring manual, and changes from baseline to follow-up in the QOL-subscales will be calculated for each individual participant.
The EORTC QLQ-H\&N35 consists of 35 items that are further divided into the following symptom scales/items: pain, swallowing, sensory problems, speech problems, trouble with social eating, trouble with social contact, less sexuality, teeth, opening mouth, dry mouth, sticky saliva, coughing, felt ill, pain killers, nutritional supplements, feeding tube, weight loss, weight gain.
All scales and single-item measures range in score from 0 to 100. A high score represents a higher response level. Thus a high score for symptom scale represents a high level of symptoms.
Measured: Difference between measurements at baseline and at follow-up after 3 and 6 months
Change in health-related quality of life (EQ-5D-5L) from baseline to follow up
Health-related quality of life (QOL) is measured using EQ-5D-5L. Questionnaires will be scored according to manual, and changes from baseline to follow-up in the QOL-subscales will be calculated for each individual participant.
Measured: Difference between measurements at baseline and at follow-up after 3 and 6 months
Percentage change in hand grip strength from baseline to follow up
Hand grip strength will be measured with a calibrated hand dynamometer at baseline and at follow up. Measurements will be performed by trained health professionals and standardised protocols will be followed. Three measurements will be performed for each participant and the mean will be calculated. The change in percent will be calculated for each individual participant.
Measured: Difference between measurements at baseline and at follow-up after 3 and 6 months
Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up
'30 seconds sit-to-stand-test' will be performed at baseline and follow-up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant.
Measured: Difference between measurements at baseline and at follow-up after 3 and 6 months
Percentage change in '6 minutes walk test' from baseline to follow up
'6 minutes walk test' will be performed at baseline and follow-up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant.
Measured: Difference between measurements at baseline and at follow-up after 3 and 6 months
Percentage change in mouth opening from baseline to follow up
Mouth opening will be measured at baseline and follow-up with TheraBite® Range-Of-Motion ROM Scale. The Therabite® ROM Scale is a disposable paper scale that measures the distance (in millimeters) between the upper and lower front teeth on maximal mouth opening. Lower values indicates trismus and increase indicates improvement. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant.
Measured: Difference between measurements at baseline and at follow-up after 3 and 6 months
Change in symptoms of anxiety and depression from baseline to follow up
Symptoms of anxiety and depression is measured with the Hospital Anxiety and Depression Scale
Measured: Difference between measurements at baseline and at follow-up after 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start15 Apr 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, University of Southern Denmark, University College Copenhagen, Odense Patient Data Explorative Network, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Marianne Boll Kristensen, Odense University Hospital
- Investigators
- Ann-Dorthe Zwisler, Professor, Study director, REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909256
- Sponsor's protocol ID
- 18/14847
- Status last verified
- Dec 2019
- First submitted
- 5 Apr 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Within the confines of Danish legislation, anonymised data from the trial will be available for other researchers upon reasonable request when results have been published.
Publications
Kristensen MB, Wessel I, Beck AM, Dieperink KB, Mikkelsen TB, Moller JK, Zwisler AD. Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial). Nutr J. 2020 Mar 17;19(1):21. doi: 10.1186/s12937-020-00539-7.
PubMed 32183835
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRI-HAB - A Randomised Controlled Trial on the Effect of a Targeted Residential Rehabilitation Program With a Focus on Eating Problems After Treatment for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03909256
- Acronym / sponsor ID
- 18/14847
- Conditions
- Head and Neck Cancer
- Keywords
- Rehabilitation, Nutrition impact symptoms, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, University of Southern Denmark, University College Copenhagen, Odense Patient Data Explorative Network, Copenhagen University Hospital, Rigshospitalet
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 9 Apr 2019 (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 study is a randomised controlled trial that aims to test the effect of a residential rehabilitation program with a focus on eating problems after treatment in head and neck cancer survivors. The study will furthermore investigate whether selected nutrition screening and assessment tools can be used to identify head and neck cancer survivor who benefit from the program.
Detailed description
This study is a randomised controlled trial with following objectives:
- To test the effect of a targeted residential rehabilitation program with focus on the physical, psychological and social aspects of eating problems on body weight, health-related quality of life and physical function in curatively treated head and neck cancer survivors 1-5 years after completion of radiation therapy
- To test whether a potential effect of the program is associated with/dependent of the participants' score in Scores Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF), Nutrition Risk Screening 2002 (NRS 2002) or M.D. Anderson Dysphagia Inventory (MDADI) at baseline
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NUTRI-HAB | Experimental | Other: NUTRI-HABThe intervention group participates in a targeted rehabilitation program 'NUTRI-HAB' with a focus on eating problem after treatment for head and neck cancer. The program comprises: * a five day residential stay with patient education * a two day follow-up residential stay after 3 months * two telephone consultations with clinical dietitian between the two residential stays. |
| Control group | No intervention | –The control group receives no intervention other than usual care in the study period. After 3 months, the control group will be offered participation in the same residential rehabilitation program as the intervention group parcitipated in. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cancer of the larynx, pharynx or oral cavity
- Treatment with radiation therapy completed 1-5 years before inclusion
- Curatively treated
- Expression of interest in participating in the rehabilitation program in a preceding survey
- Self-reliant and no need for assistance with personal hygiene etc.
Key exclusion criteria (3 listed)
- Active cancer disease at the time of recruitment
- Not being able to speak and understand Danish
- No permanent residence in Denmark
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 |
|---|---|---|
| NUTRI-HABThe rehabilitation program is a coordinated multidisciplinary effort involving several specialists e.g. clinical dietitians, nurses, physiotherapists, occupational therapists (responsible for dysphagia management in Denmark), psychologists and social workers. The program includes group sessions with patient education on how to handle the different aspects of living with eating problems and other late effects. Practical kitchen exercises, physical activity sessions and instruction in swallowing training are included. Individual counseling sessions with clinical dietitians and other health professionals (e.g. physicians) are offered depending on participants' needs. Participants stay at the premises and all meals throughout the day are served in the dining room or in the café. Foods of different textures and flavors are served to inspire participants and to allow them to experiment. Between the initial stay and follow-up participants are contacted twice by a clinical dietitian. | Other | NUTRI-HAB |
Primary outcome
Percentage change in body weight from baseline to follow up
Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Body weight will be measured with a calibrated scale at baseline and at follow up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant and be used as the primary outcome.
8 secondary outcomes
Change in health-related quality of life (EORTC QLQ-C30) from baseline to follow up
Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Change in health-related quality of life (EORTC QLQ-H&N35) from baseline to follow up
Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Change in health-related quality of life (EQ-5D-5L) from baseline to follow up
Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Percentage change in hand grip strength from baseline to follow up
Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up
Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Percentage change in '6 minutes walk test' from baseline to follow up
Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Percentage change in mouth opening from baseline to follow up
Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Change in symptoms of anxiety and depression from baseline to follow up
Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 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 17 Dec 2019.
- Derived from this study: PubMed 32183835Kristensen MB, Wessel I, Beck AM, Dieperink KB, Mikkelsen TB, Moller JK, Zwisler AD. Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial). Nutr J. 2020 Mar 17;19(1):21. doi: 10.1186/s12937-020-00539-7.
- Individual participant dataSharing planned: No. Within the confines of Danish legislation, anonymised data from the trial will be available for other researchers upon reasonable request when results have been published.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Ann-Dorthe Zwisler, Professor study director
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUTRI-HAB in people with Head and Neck Cancer, run by Odense University Hospital 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 5 inclusion and 3 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 17 Dec 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?
Percentage change in body weight from baseline to follow up (time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909256, which also lists 1 linked publication.
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 17 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.