Clinical trial NCT02385929: Pre-habilitation of Patients With Head and Neck Cancer
Official title: Bimodal Pre-habilitation Program to Improve Symptom Control After Treatment for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Intervention
Rehabilitation
Late Effects
Dysphagia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Danish Association of Occupational Therapist
name: Rigshospitalet, Denmark
name: Danish Cancer Research Foundation
First posted: 2015-03-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Histological proven cancer in one or more of the following areas: larynx, hypopharynx, oropharynx, cavi oris, or unknown primary tumor
* Set to curative radiotherapy with or without concurrent chemotherapy for treatment of cancer in the head and neck region in accordance with the Danish Head and Neck Cancer Group (DAHANCA) guidelines
* Fully self-reliant
* Danish skills, oral and written
* Informed consent

Exclusion Criteria:

* Previously received treatment for head and neck cancer (radiotherapy, chemotherapy and/or surgery).
* Pregnancy
* ECOG performance status \> 2
* Presence of psychological-, family-, sociological- or geographical issues that could prevent the patient from completing the intervention
* Simultaneous or previous illness or conditions that could prevent the patient's ability to complete the intervention.

Primary outcomes:
measure: Swallowing function measured by penetration aspiration scale (PAS) during a Fiber Endoscopic Evaluation of Swallowing (FEES).
timeFrame: Baseline, 14 weeks and 58 weeks. Participants will be followed up till 12 months after they finalize their radiotherapy, an expected average of 58 weeks from baseline.
Secondary outcomes:
measure: Level of fatigue by the EORCT QLQ-C30 3-point fatigue subscale.
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Maximal Interincisal Distance (MID) by Therabite Range of Motion (ROM) scale
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Dysphagia related quality of life by M.D. Anderson Dysphagia Inventory (MDADI)
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Health related quality of Life by the European Organisation for Research and Treatment of Cancer (EORCT) Quality if Life Questionnaire (QLQ)-30 and EORCT QLQ - H&N35
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Level of oral intake by Functional Oral Intake Scale (FOIS)
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Weight loss by body weight
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Physical strength by 30 seconds Sit to Stand (STS) test.
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Pain by numerical rating scale (NRS)
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Depression by Major Depression Inventory (MDI)
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Anxiety by Symptom Check List (SCL-92) Anxiety subscale
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Performance Status by Eastern Cooperative Oncology Group (ECOG) performance scale
timeFrame: baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.
measure: Subjective symptoms of dysphagia by Eating Assessment Tool (EAT-10)
timeFrame: Participants will be followed up till 12 months after they finalize their radiotherapy, an expected average of 58 weeks from baseline.
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Næstved Sygehus
state: Region Zealand
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Sara F Hajdú, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Cancer Society
name: Susanne O Dalton, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Christoffer Johansen, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Irene Wessel, MD, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hajdu SF, Wessel I, Johansen C, Kristensen CA, Kadkhoda ZT, Plaschke CC, Dalton SO. Swallowing therapy and progressive resistance training in head and neck cancer patients undergoing radiotherapy treatment: randomized control trial protocol and preliminary data. Acta Oncol. 2017 Feb;56(2):354-359. doi: 10.1080/0284186X.2016.1269193.
citation: Hajdu SF, Plaschke CC, Johansen C, Dalton SO, Wessel I. Cross-Cultural Translation, Adaptation and Reliability of the Danish M. D. Andeson Dysphagia Inventory (MDADI) in Patients with Head and Neck Cancer. Dysphagia. 2017 Aug;32(4):472-479. doi: 10.1007/s00455-017-9785-3. Epub 2017 Mar 7.
citation: Fredslund SV, Hogdal N, Christensen MB, Wessel I. Dysphagia training after head and neck cancer fails to follow legislation and national recommendations. Dan Med J. 2015 May;62(5):A5067.
citation: Hajdu SF, Christensen MB, Kristensen MO, Wessel I, Johansen C, Dalton S. Adherence to preventive swallowing exercises for head and neck cancer patients undergoing (chemo)radiotherapy treatment. Acta Oncol. 2019 May;58(5):658-664. doi: 10.1080/0284186X.2018.1563715. Epub 2019 Jan 30.