Clinical trial · Interventional
Rehabilitation for Head and Neck Cancer
Rehabilitation During Versus After Radiotherapy in Head and Neck Cancer - a Pilot Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight loss is attributed to lean muscle wasting that is associated with decline in physical function, substantial fatigue and significantly decreased quality of life. Rehabilitation that includes physical exercise, nutritional counselling and oral nutritional supplements (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot randomised trial is to assess feasibility, evaluate patient experiences and assess preliminary effects on muscle mass, physical function, nutritional status and quality of life of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC patients referred for curative RT with or without chemotherapy, will be randomised to a) rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be carried out at an outpatient facility during the treatment period (6-7 weeks) and rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise and nutrition during radiotherapy | Behavioral | — | UNRESOLVED |
| Multidimensional rehabilitation after radiotherapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early rehabilitation
- description
- Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements.
- interventionNames
- Behavioral: Exercise and nutrition during radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Late rehabilitation
- description
- Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education
- interventionNames
- Behavioral: Multidimensional rehabilitation after radiotherapy
Primary outcomes (1)
- measure
- Feasibility of interventions tracked by number of patients ineligible or refusing to participate, completion of interventions and attrition, adverse events and exercise/nutritional adherence.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of squamous cell cancer (SCC) originated in the head/neck (naso, oro, hypo pharynx, larynx and oral cavity) * Due to commence curative radiotherapy (RT) or chemoradiotherapy (CRT) * All baseline assessments can be completed within 4 weeks prior to first cycle of RT or CRT * Written informed consent is present * willing to comply with study procedures Exclusion Criteria: * stage T1N0M0 laryngeal cancer
References
Publications (2)
- RESULTSandmael JA, Bye A, Solheim TS, Stene GB, Thorsen L, Kaasa S, Lund JA, Oldervoll LM. Feasibility and preliminary effects of resistance training and nutritional supplements during versus after radiotherapy in patients with head and neck cancer: A pilot randomized trial. Cancer. 2017 Nov 15;123(22):4440-4448. doi: 10.1002/cncr.30901. Epub 2017 Jul 31. PMID 28759113
- RESULTSandmael JA, Bye A, Solheim TS, Balstad TR, Thorsen L, Skovlund E, Kaasa S, Lund JA, Oldervoll L. Physical rehabilitation in patients with head and neck cancer: Impact on health-related quality of life and suitability of a post-treatment program. Laryngoscope Investig Otolaryngol. 2020 Mar 17;5(2):330-338. doi: 10.1002/lio2.368. eCollection 2020 Apr. PMID 32337365