Head and Neck Cancer Clinical Trial
— SYNKOfficial title:
Bimodal Pre-habilitation Program to Improve Symptom Control After Treatment for Head and Neck Cancer
Verified date | March 2020 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | November 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen | |
Denmark | Næstved Sygehus | Næstved | Region Zealand |
Lead Sponsor | Collaborator |
---|---|
Irene Wessel | Danish Association of Occupational Therapist, Danish Cancer Research Foundation, Danish Cancer Society, Rigshospitalet, Denmark |
Denmark,
Fredslund SV, Høgdal 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). pii: A5067. — View Citation
Hajdú 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. — View Citation
Hajdú 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Swallowing function measured by penetration aspiration scale (PAS) during a Fiber Endoscopic Evaluation of Swallowing (FEES). | To investigate the change in swallowing function among patients in intervention- and the control group from baseline to 14 and 58 weeks follow up and the difference in change between intervention - and the control group. | 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 | Level of fatigue by the EORCT QLQ-C30 3-point fatigue subscale. | To investigate the change in fatigue among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Maximal Interincisal Distance (MID) by Therabite Range of Motion (ROM) scale | To investigate the change in mouth opening and the development of trismus (defined as MID = 35mm) among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Dysphagia related quality of life by M.D. Anderson Dysphagia Inventory (MDADI) | To investigate the change in patient reported quality of life related to dysphagia among patients in intervention- and the control group from baseline to 6, 14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. We will also use this outcome to evaluate correlation or deviations in patient vs observer rated outcomes by comparing the MDADI to the PAS score (primary outcome). | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | 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 | To investigate the change in health related quality of life among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Level of oral intake by Functional Oral Intake Scale (FOIS) | To investigate the change in oral intake and tube dependency among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Weight loss by body weight | To investigate the change in weight loss among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Physical strength by 30 seconds Sit to Stand (STS) test. | To investigate the change in lower extremities' strength as an expression of the overall physical strength among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Pain by numerical rating scale (NRS) | To investigate the change in pain among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Depression by Major Depression Inventory (MDI) | To investigate the change in depressive symptoms among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Anxiety by Symptom Check List (SCL-92) Anxiety subscale | To investigate the change in anxiety among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Performance Status by Eastern Cooperative Oncology Group (ECOG) performance scale | To investigate the change in performance status among patients in intervention- and the control group from baseline to 6,14, 28 and 58 weeks follow up and the difference in change between intervention - and the control group. | baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks. | |
Secondary | Subjective symptoms of dysphagia by Eating Assessment Tool (EAT-10) | EAT-10 is a questionnaire screening tool used to evaluate patient-experienced symptoms of dysphagia and measures the level of ten specific difficulties related to swallowing. We will measure this outcome at the same time as our primary outcome to analyze the correlation between the subjective and objective measures of oropharyngeal dysphagia. | Participants will be followed up till 12 months after they finalize their radiotherapy, an expected average of 58 weeks from baseline. |
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