The aim of this study is both a feasibility study to gain a comprehensive understanding of the feasibility, satisfaction and impact, and trends of the effects of a physical exercise and nutritional intervention in patients who will be treated by a…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adherence and compliance of the physical exercise intervention and the
participants* experiences of the physical exercise intervention.
Secondary outcome
* Recruitment of patients
* Retention rate
* Compliance with nutritional prescription
* Physical fitness (6MWT, SRT)
* Physical muscle strength (grip strength, lower and upper muscle strength,
30s-SCT, 8-RM).
* Physical activity (SQUASH)
* Body composition (FFM by BIA, BMI)
* Nutritional status (PG-SGA).
* Quality of life (EORTC-QLQ-C30, EORTC-QLQ-H&N35, EQ-5D-5L)
* Fatigue (MFI)
* Surgical complications and adverse events (Clavien-Dindo classification and
adverse events until 3 to 4 weeks after laryngectomy, CTCAE).
Background summary
In people with cancer, sarcopenia is often present at the time of diagnosis,
typically due to a combination of factors such as disease activity, inactivity
and malnutrition. In individuals undergoing surgical treatment for their
cancer, those with sarcopenia experience more postoperative complications,
longer hospital stays, and shorter overall survival. It is of importance to
address the degree of sarcopenia before a laryngectomy.
Study objective
The aim of this study is both a feasibility study to gain a comprehensive
understanding of the feasibility, satisfaction and impact, and trends of the
effects of a physical exercise and nutritional intervention in patients who
will be treated by a total laryngectomy.
Study design
Prospective feasibility study
Intervention
A moderate to high-intensity personalized physical exercise intervention
combined with a nutritional intervention will take place in 7 patients 3 to 5
weeks prior to their total laryngectomy.
Study burden and risks
Visits scheduled for assessments will be combined with the laryngectomy
treatment-related visits as much as possible. Dietary treatment follow-up
visits will be done by telephone. The physical exercise program will be
supervised three times per week by an oncology physiotherapist at private
physiotherapy practices as close as possible to home and three other days of
that week the patient will be active for at least 30 minutes.
The patient will be asked two times to spend, at most, 30 minutes completing
questionnaires and two times to spend at most 90 minutes performing physical
and nutritional tests and keep an activity and food diary (weekly) and to
participate in one semi-structured interview (30 minutes). These tests, diaries
and questionnaires have been used in an exercise intervention study during head
and neck cancer related radiotherapy.
As in any exercise situation, injuries due to exercise can occur; to minimize
the risk, the intensity of the exercise program will be gradually increased
during the study and the program will be supervised by a physiotherapist. The
estimated extra risk for the patient while participating in this study is low.
Possible benefits for participants are a reduction in fatigue, an increase of
physical fitness and less total laryngectomy related complications possibly
leading to prosperous recovery and better quality of life.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
• Subject must undergo a laryngectomy
• Low skeletal muscle mass (SMM) (see also paragraph 8.1.3), based on CT or MRI
scans of the head and neck area at level C3.
• Karnofsky Performance status >60
• Able to walk >=6 m without a mobility aid
• >=18 years
• Sufficient Dutch writing and reading skills
Exclusion criteria
• Patients exercising more than in the prescribed physical exercise
intervention of this study
• For patients participating in the physical exercise and nutritional
intervention: <3 weeks to participate in the study intervention
Design
Recruitment
Medical products/devices used
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 | NL87134.041.24 |