This study primarily aims to explore changes in physical activity pattern and energy expenditure in head and neck cancer patients, during and after treatment with surgery with or without (chemo)radiation. The secondary aim of this study is to gain…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
ondervoeding; hoofd-halskanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Daily step count
- Energy expenditure
Secondary outcome
Quantitative study:
Secondary outcome variables:
- Types of physical activity
- Muscle mass/fat-free mass (kg)
- Muscle strength (number of stand ups)
- Estimated energy expenditure (kcal)
Co-variables
- Age
- Gender
- Body weight
- Body Mass Index (BMI)
- Malnutrition (PG-SGA score C)
- Frailty
- Dietary intake (protein in gr/d; energy, in kcal/d)
- Self regulation
- Self efficacy
- Motivation
- Fatigue
- Smoking and drinking habits
- Performance status
- Tumor- or treatment-related symptoms
- Comorbidity
Qualitative study:
The qualitative research will give insight in physical activity and exercise
barriers and facilitators, and preferences by head and neck cancer patients.
Background summary
Head and neck cancer patients lose muscle mass and muscle strength during
treatment with (postoperative) radiotherapy or chemoradiation. Patients lose
about 5% of their fat-free mass, an indicator of muscle mass, and about 10% of
their hand grip strength (Jager-Wittenaar et al., 2011a) in that period.
Malnutrition, characterized by loss of muscle mass and muscle strength, affects
quality of life (Ravasco et al., 2004; Jager-Wittenaar et al., 2011b), and
increases morbidity and mortality. Malnourished patients seem to be prone to
toxic effects of chemotherapy, resulting in dose reductions and treatment
interruptions (Fearon et al., 2011). Furthermore, malnutrition results in a
shorter survival and a prolonged hospital stay and higher health care costs
(Correia & Waitzberg, 2003; Datema e.a., 2011).
Loss of muscle mass and strength during head and neck cancer treatment is
multifactorial. Besides local factors, systemic factors are involved. Local
factors are tumor- and treatment-related oral symptoms, resulting in reduced
food intake (Jager-Wittenaar et al., 2007; Jager-Wittenaar et al., 2011c).
Depending on the type of tumor, patients are treated with either surgery,
radiotherapy or chemoradiation, or combinations. Both surgery and
(chemo)radiation induce problems with chewing and swallowing and especially the
combination of both types of treatment hamper oral food intake. Therefore, head
and neck cancer patients routinely receive dietary counselling by a dietitan,
in order to meet nutritional requirements (e.g. energy and protein).
Systemic factors are disease-related and radiation-induced inflammation
activity (Ehrsson et al., 2009; Ki et al., 2009), which cause breakdown of
muscle protein. Furthermore, the treatment is accompanied by fatigue. As a
result, patients may reduce their daily physical activity (Rogers et al.,
2008). Hence, muscle protein synthesis will decline, resulting in loss of
muscle mass (*disuse atrophy*) (Guadagni & Biolo, 2009). The proportion of head
and neck cancer patients not meeting the public health exercise guidelines
increases from 69% pre-treatment to 91% post-treatment (Rogers et al., 2006).
Given the decreased physical activity and malnutrition, head and neck cancer
patients may have symptoms of frailty as well.
Dietary treatment including a protein and energy enriched diet cannot prevent
loss of muscle mass and strength during and after head and neck cancer
treatment (Jager-Wittenaar et al., 2011a). Furthermore, patients may not regain
body weight lost during treatment, despite sufficient intake (Jager-Wittenaar
et al., 2011b). As not only food intake is an anabolic stimulus (Rennie et al,
1982), but physical exercise is another anabolic stimulus (Chesley at al,
1992), we hypothesize that lack of physical activity may contribute to loss of
muscle mass and strength in head and neck cancer patients.
Until now, little is known about physical activity, intensity and frequency, of
head and neck cancer patients and its relationship with loss of muscle mass and
strength. Insight in physical activity, intensity and frequency, is needed, to
determine whether physical activity needs to be stimulated in these patients,
in order to lower the risk of disuse atrophy contributing to the risk for
malnutrition.
Moreover, to be able offer a tailored exercise intervention in the future, the
interventions should meet specific demands of head and neck cancer patients.
Therefore, insight is needed in which factors hinder and facilitate physical
activity and exercise in head and neck cancer patients, as well as insight in
physical activity and exercise preferences of these patients.
Moreover, measurement of physical activity also enables gain of knowledge on
energy expenditure of head and neck cancer patients. In clinical practice,
total energy expenditure is estimated. However, use of current formulae to
predict energy expenditure results in prediction errors, resulting in over- or
underfeeding. Insight in energy expenditure from physical activity and its
relationship with physical performance status is needed, to reduce prediction
errors.
Study objective
This study primarily aims to explore changes in physical activity pattern and
energy expenditure in head and neck cancer patients, during and after treatment
with surgery with or without (chemo)radiation.
The secondary aim of this study is to gain insight in perceived exercise
barriers and facilitators, and exercise preferences of head and neck cancer
patients.
Study design
The quantitave part of the study has an explorative, longitudinal design.
The qualitative part of the study has a cross-sectional design.
Study burden and risks
Participation in this study is not expected to cause any additional physical
harm to the subjects* health. Wearing the SenseWearPro armband poses no health
risk (Bodymedia, 2010). The most frequently reported side effect, occurring in
less than 1% of users, is a mild to severe skin irritation resulting from
wearing the Armband. This issue is easily resolved by following proper wear and
cleaning guidelines. Participants will receive instructions regarding wear and
cleaning guidelines. Participants will also be instructed to discontinue use
and consult a physician regarding skin irritations in case skin irritation
occurs.
All measurements are considered non-invasive, as no blood samples will be
collected en subjects will not be exposed to radiation.
All study measurements will be conducted three times: 1) one week before start
of treatment, 2) six weeks after end of treatment, and 3) three months after
end of treatment. All study measurements will be planned shortly before or
after a regular control visit to the physician.
Participants will be asked to fast 4 hours before the study measurements.
At the three study measurements, the following non-invasive tests will be
performed within the 90 minutes:
weight, length, mid upper arm circumference, triceps skinfold, calf
circumference, hand grip strength, chair to stand test, bio-electrical
impedance analysis, and indirect calorimetry.
Furthermore, the following questionnaires will be filled in: Patient-Generated
Subjective Global Assessment (PG-SGA), Frailty Instrument for Primary Care of
the Survey of Health, Ageing and Retirement in Europe (SHARE-FI), MVI-20,
Self-Regulation Questionnaire Exercise, Exercise Self Efficacy Scale, WHO
performance score, and EORTC QLQ-HN35.
Moreover, the participants will wear a pedometer during one week, three times.
In that week, the participant will also wear an accelerometer (SenseWearPro
armband) and fill in a food diary during three days.
In addition to the measurements performed during the three study measurements,
participants wil be asked to be interviewd once, six weeks post-treatment. The
duration of this in-depth interview will be 60 minuts at maximum.
If indicated necessary based upon the results of this study, this study will be
followed by an intervention study to evaluate effectiveness of one ore more
interventions. Moreover, insight in energy expenditure will give practitioners
tools to reduce risk of overfeeding and underfeeding.
As the study is not expected to cause any additional physical harm to the
subjects* health, we consider the burden of participation in proportion to the
potential value of the research.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Newly diagnosed T1, T2, T3 or T3 malignancy in the oral cavity, larynx, oro- or hypopharynx, to be treated with surgery with or without (chemo)radiation
- Age: >=18 years
- Able to understand and speak the Dutch language
Exclusion criteria
- Second primary tumor, outside the head and neck region
- Fibula transplantation
- Wheel chair dependency
- Comorbidity with a contra-indication for physical exercise
- Severe cognitive disabilities
- Skin allergy or highly sensitive skin
- Palliative treatment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL39927.042.12 |