Head and Neck Cancer Clinical Trial
Official title:
Bimodal Pre-habilitation Program to Improve Symptom Control After Treatment for Head and Neck Cancer
The purpose of this study is to explore whether early initiated physical exercise concurrent with a swallowing and mouth opening exercise program will have a positive effect on swallowing function and other quality of life aspects in patients treated with radiotherapy for head and neck cancer. The investigators hypothesize that patients who complete the program will have improved swallowing function and physical function one year after completing their treatment compared to patients who do not participate in the training program.
Although the potential negative impact of head and neck cancer (HNC) and its treatment on
eating ability and quality of life is well documented there is no evidence based and
standardized rehabilitation program available for Danish patients affected by HNC while going
through radiotherapy (with or without concurrent chemotherapy). This study proposal is based
on a thorough literature review on HNC treatment and late effects, and interventions
targeting dysphagia and physical functioning.
Traditionally, rehabilitation is initiated when loss of function is already established.
Emerging evidence suggests, however, that it can be of benefit to the patient to initiate an
early rehabilitation process (prehabilitation) starting before initiation of treatment and
during treatment. Prehabilitation aims to enhance pre-treatment functional capacity for
better tolerance of treatment, facilitate general recovery, and prevent development of
functional impairment or reduce the extent of these problems in a long-term perspective. HNC
patients have a unique set of functional challenges such as pre- and post-treatment
dysphagia, pain, and weight loss and often also high baseline levels of alcohol and tobacco
consumption. In addition, studies have shown that only 31 % and 9 % of HNC patients are
meeting public health guidelines for physical activity before and after diagnosis,
respectively, and that weight loss in HNC patients treated with chemoradiation begin after
only 1 week of therapy. Most of the weight loss was lean body mass (LBM) rather than fat
loss. Loss of LBM is significantly associated with physical performance and increased
functional dependence. The level of physical activity typically decreases significantly
during treatment.
Dysphagia is considered the most prominent complication to HNC and its treatment, affecting
physical function and quality of life. Post treatment dysphagia occurs in a significant
proportion of patients and results from multiple factors such as xerostomia, taste loss,
decreased sensory function, fibrosis and trismus. Disuse of swallowing muscles due to acute
radiation effects or tube feeding can contribute to decline in swallowing function. Often,
difficulties in swallowing and mouth opening are presenting features of HNC even at the time
of diagnosis. To reduce these problems, patients may do a series of exercises before and
during treatment to promote strength, mobility, and endurance of base of tongue, pharyngeal
constrictors, and suprahyoid strap muscles. Although no definitive trials have yet been
carried out, small randomized controlled trials (RCTs) and observational studies
investigating pre-treatment swallowing and/or mouth opening exercise programs show promising
benefits. Further, the few studies of resistance and cardio training on functional capacity
in HNC patients are generally promising with medium to large effects on fatigue and physical
function measures. For weight loss it seems as if progressive resistance training (PRT) is
able to almost reverse the loss of LBM in HNC patients.
Generally studies on swallowing therapy for HNC patients have relied greatly on
self-practice, and thus report low compliance. In view of this knowledge the investigators
determine that there is a need for studies that include patients with HNC undergoing
(chemo)radiation therapy focusing on i) prevention of dysphagia and loss of muscle strength
and ii) improvement of compliance to mouth opening and swallowing exercises.
The purpose of the SYNK study is a randomized design to test the effect of theory based
intervention on eating dysfunctions secondary to radiation treatment for HNC. The SYNK
intervention consists of: i) individual instructions in swallowing and mouth opening
exercises 3 days per week by occupational therapist throughout radiotherapy, ii) progressive
resistance training twice weekly by physiotherapist, either individually or group based,
throughout radiotherapy, iii) daily home-based swallowing and mouth opening exercises from
beginning of treatment until 2 months after end-of-treatment (self-practice), and iv) weekly
follow-up phone contacts with occupational therapists from end-of-treatment and 2 months
onwards.
The investigators will enroll patients from the Oncological Department Rigshospitalet and
randomize 240 patients. Patients will be randomized (1:1) to standard care plus the SYNK
intervention and to standard care (control group).
The proposed study has the potential to support the general health status of HNC patients as
well as to minimize adverse late effects of treatment (i.e. swallowing and mouth opening
difficulties, general physical deterioration due to physical inactivity and problems with
eating, and reduced QoL). The design of the intervention, being early, intensive and bimodal
adds a new dimension to research in the prevention of devastating late effects in this
particularly vulnerable patient group.
The investigators hypothesize that the SYNK intervention will:
- Improve swallowing function
- Improve physical function to stop the loss of muscle strength
- Improve quality of life and lessen the symptoms of anxiety and depression
;
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