Fredslund 2015.
| Trial name or title | Pre‐habilitation of patients with head and neck cancer SYNK |
| Methods | RCT; efficacy study, single‐centre |
| Participants | Age: minimum: 18 years; maximum: N/A
Gender: both Inclusion criteria: ‐ Histological proven cancer in one or more of the following areas: larynx, pharynx, cavi oris, cavi nasi, salivary glands, thyroid, sinuses, head and neck cancer; metastases to the neck lymph nodes, or unknown primary tumour ‐ 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 being able to complete the intervention Sample size: 240 |
| Interventions | Behavioural: swallowing therapy and resistance training |
| Outcomes |
Primary: swallowing function measured by penetration aspiration scale (PAS) during a Fibre‐Endoscopic Evaluation of Swallowing (FEES) (Time frame: participants will be followed up until 12 months after they finalise their radiotherapy, an expected average of 58 weeks from baseline) Secondary: ‐ Anxiety by Symptom Check List (SCL‐92) Anxiety subscale ‐ Body composition by bioimpedance ‐ Depression by Major Depression Inventory (MDI) ‐ Health‐related quality of life by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)‐30 and EORTC QLQ‐H&N35 ‐ Level of fatigue by the EORTC QLQ‐C30 3‐point fatigue subscale. ‐ Level of oral intake by Functional Oral Intake Scale (FOIS) ‐ Maximal inter‐incisal distance (MID) by Therabite range of motion (ROM) scale ‐ Pain by numerical rating scale (NRS) ‐ Performance Status by Eastern Cooperative Oncology Group (ECOG) performance scale ‐ Physical strength by 30 seconds Sit to Stand (STS) test ‐ Subjective symptoms of dysphagia by EAT‐10 (eating assessment tool) ‐ Weight loss by body weight |
| Starting date | May 2015 |
| Contact information | Sara V Fredslund, MSc Danish Cancer Society Rigshospitalet, Denmark sara.vinther.fredslund@regionh.dk Ph: 0045 51908661 |
| Notes | Efficacy study, intervention model: parallel assignment, masking: single blind (outcomes assessor) Primary purpose: supportive care Primary sponsor: Irene Wessel Secondary sponsors:
Identifiers: H‐2‐2014‐074 R108‐A6969‐14‐S31 |