To improve normalcy of food intake (food quantity and quality, decrease use of tube feeding/ nutritional supplements) in patients with head and neck cancer with pre-, per- and post treatment radiotherapy due to individually tailored swallowing…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Quality of food intake ( based on food modifications)
-Use of tube feeding/diet supplements
Secondary outcome
-Quality of Life
-Nutritional status
Background summary
Oral nutrition appears to be a challenge for patients with head and neck cancer
(HNC patients) after radiotherapy. Many patients desire to their usual food
intake and to return to oral nutrition with normal consistency (without
modifications) but due to the swallowing problems experienced post treatment
this seems tremendously difficult. Referral to a speech therapist is not a
standard procedure in the RUNMC as part of pre-, -per and post-treatment
radiotherapy. Swallowing intervention might support nutritional intervention
and in that way improve quantity and quality of food intake, reduce the need
for tube feeding.
Study objective
To improve normalcy of food intake (food quantity and quality, decrease use of
tube feeding/ nutritional supplements) in patients with head and neck cancer
with pre-, per- and post treatment radiotherapy due to individually tailored
swallowing therapy by an experienced speech-language therapist in cooperation
Individual dietary councelling by an experienced dietician.
Secondary objectives are:
-patients quality of life
-nutritional status.
Study design
A prospective, randomized study will be carried out at the department of
Radiotherapy, Rehabilitation and Gastroenterology - dietetics, RUNMC. One group
will receive individualized swallowing therapy by a speech-language therapist
(SLT), pre-, per- and post treatment in cooperation with extensive dietary
councelling by a specialized dietician. The other group will have standard
usual care for head and neck cancer patient treated with radiotherapy including
extensive dietary councelling by a specialized dietician.
Intervention
The experimental group will be monitored and treated (when needed) by an
experienced SLT to compensate for any consequence of the tumor or adverse event
of the radiotherapy on the efficiency or safety of oropharyngeal swallowing, as
is recommended by the Dutch guidelines. The monitoring and interventions will
start as soon as the radiotherapy has been decided and planned, until 6 months
after the last radiotherapy session. To further optimize the efficacy and
efficiency of the rehabilitation the SLT cooperates closely with an experienced
dietician by protocol, to ensure that every patient receives the most suitable
nutritional advice at every moment from pre-radiotherapy until 6 month after
radiotherapy.
Study burden and risks
Not applicable
Geert Grooteplein 10
6500 HB Nijmegen
NL
Geert Grooteplein 10
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
1. Patients >= 18 years.
2. Patients with tumor in Oral cavity, nasopharynx, oropharynx, hypopharynx or larynx with tumor stage II-IV (UICC TNM-tumor classification)
3. Eligible for primary curative treatment intentions with (chemo)radiation or adjuvant radiotherapy
4. A signed informed consent.
Exclusion criteria
1. Historical swallowing problems ( neurological or not tumor related).
2. Unable to comprehend and carry out the swallowing intervention.
3. Unable to answer study questionnaires. (illiterate)
4. Radiation or surgery for Head and neck cancer in history.
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 | NL28638.091.09 |