Clinical trial NCT03909256: NUTRI-HAB - Posttreatment Rehabilitation of Nutrition Impact Symptoms in Head and Neck Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Rehabilitation
Nutrition impact symptoms
Quality of life
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
name: University of Southern Denmark
name: University College Copenhagen
name: Odense Patient Data Explorative Network
name: Rigshospitalet, Denmark
First posted: 2019-04-09
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

1. 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
2. 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Active cancer disease at the time of recruitment
* Not being able to speak and understand Danish
* No permanent residence in Denmark

Primary outcomes:
measure: Percentage change in body weight from baseline to follow up
timeFrame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Secondary outcomes:
measure: Change in health-related quality of life (EORTC QLQ-C30) from baseline to follow up
timeFrame: Difference between measurements at baseline and at follow-up after 3 and 6 months
measure: Change in health-related quality of life (EORTC QLQ-H&N35) from baseline to follow up
timeFrame: Difference between measurements at baseline and at follow-up after 3 and 6 months
measure: Change in health-related quality of life (EQ-5D-5L) from baseline to follow up
timeFrame: Difference between measurements at baseline and at follow-up after 3 and 6 months
measure: Percentage change in hand grip strength from baseline to follow up
timeFrame: Difference between measurements at baseline and at follow-up after 3 and 6 months
measure: Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up
timeFrame: Difference between measurements at baseline and at follow-up after 3 and 6 months
measure: Percentage change in '6 minutes walk test' from baseline to follow up
timeFrame: Difference between measurements at baseline and at follow-up after 3 and 6 months
measure: Percentage change in mouth opening from baseline to follow up
timeFrame: Difference between measurements at baseline and at follow-up after 3 and 6 months
measure: Change in symptoms of anxiety and depression from baseline to follow up
timeFrame: Difference between measurements at baseline and at follow-up after 3 and 6 months
Other outcomes:
Locations:
city: Nyborg
country: Denmark
facility: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Study officials:
affiliation: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
name: Ann-Dorthe Zwisler, Professor
role: STUDY_DIRECTOR
References:
citation: 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.