To investigate the effect of nutritional prehabilitation on adverse events in patients with locoregionally advanced head and neck cancer, with low to medium risk of malnutrition and with radiological sarcopenia. To evaluate its effect on patient-…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adverse events (i.e., intra- and postoperative complications and
(chemo)radiotherapy toxicity). Complications will be measured within 30 days
after surgery using the Clavien-Dindo classification. Toxicity will be
evaluated using the Common Terminology Criteria for Adverse Events (CTCAE),
version 4.0, 6 weeks after the start of (chemo)radiotherapy.
Secondary outcome
Patient-reported quality of life (i.e., the EAT-10, EORTC H&N35 and EORTC C30
questionnaires), recurrence, (disease-specific and overall) survival, and
cost-utility and cost-effectiveness (measured using the EQ-5D-5L, adverse
events, iMCQ and iPCQ).
Background summary
Up to 60% of patients with head and neck cancer are malnourished upon first
presentation. Malnutrition has been associated with more adverse events and
lower quality of life and survival. According to current Dutch guidelines,
patient with high risk of malnutrition receive pretreatment dietary treatment.
A recent study has shown that patients with low to medium risk of malnutrition,
may benefit from additional screening and subsequent nutritional
prehabilitation.
Study objective
To investigate the effect of nutritional prehabilitation on adverse events in
patients with locoregionally advanced head and neck cancer, with low to medium
risk of malnutrition and with radiological sarcopenia. To evaluate its effect
on patient-reported quality of life outcome measures, recurrence and
(disease-specific and overall) survival. To evaluate the cost-effectiveness of
nutritional prehabilitation compared to standard care.
Study design
A single-center, non-blinded, randomized controlled trial.
Intervention
One group will receive nutritional prehabilitation and one group will receive
standard care (which means they will not receive nutritional prehabilitation).
Study burden and risks
Patients will be asked to undergo several measurements that are not part of our
current standard practice. These measurements entail one grip strength
measurement, three BIA-measurements and the following questionnaires: EAT-10,
iMCQ and iPCQ at respectively six time points, four time points and four time
points. Furthermore, the intervention itself will require three sessions with a
dietitian, either during a regular visit at the outpatient department or
through a telephone/video call. The time burden of these extra measurements and
the intervention is 185 minutes on average.
There are no risks associated with the investigational treatment.
We expect that nutritional prehabilitation will lead to fewer (serious)
complications and side effects compared to no nutritional prehabilitation. We
expect a higher quality of life, equal chance of recurrence and better
survival.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Primary mucosal squamous cell carcinoma;
- Located in the oral cavity, oropharynx, hypopharynx or larynx;
- Locoregionally advanced disease defined as stage III and stage IV disease;
- Treated with curative intent;
- Low or medium risk of malnutrition based on the MUST;
- Low skeletal muscle mass determined by CT defined as LSMI lower than 46.5
cm2/m2 for men and lower than 37.9 cm2/m2 for women;
- Pre-treatment CT scan performed up to 30 days before treatment;
- Age >=18 years;
- Written informed consent.
Exclusion criteria
- Previous surgical or radiotherapeutic treatment of the neck;
- Multiple simultaneous primary malignancies;
- Disability that could interfere with questionnaire fulfillment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87676.042.24 |