Head and Neck Cancer
Conditions
Brief summary
Head and neck cancer patients often experience a critical weight loss of around 10% following radiation therapy. Of this up to 70% is muscle mass and is an independent predictor of mortality, lowers muscle strength and functional performance. The purpose of this study is in a randomized controlled trial to investigate the effects of progressive resistance training (PRET) on changes in muscle mass, muscle strength and functional performance in head and neck cancer survivors. The investigators hypothesize that PRET has a positive effect on all primary endpoints and increases muscle mass, muscle strength and functional performance.
Interventions
12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training
Sponsors
Danish Head and Neck Cancer Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically diagnosed with squamous cell carcinomas of the larynx (no glottis stage I+II), pharynx, oral cavity or in lymph nodes from an unknown primary tumour (stage I-IV and tumour node metastasis (TNM) classification, UICC, Geneva, 1987) * Terminated curative radiotherapy treatment with/without chemotherapy; * No metastases * Complete tumour remission * No current or previous malignancies that could prevent participation and training * No excessive alcohol intake (men \> 21 and women \> 14 units/wk) * No recent systematic resistance training or creatine ingestion (within 2 months) * If woman, not pregnant * WHO performance status of 0-1 * No psychological, social or geographical conditions that could disturb participation * Written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | Baseline, 3 months and 6 months | Lean body mass and fat mass assessed by DEXA scanning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal gait speed | Baseline, 3 months and 6 months | 10 m walk time |
| Patient reported outcomes | Baseline, 3 months and 6 months | Questionaires on Quality of Life, Fatigue and Mood |
| Blood sampling | Baseline, 3 months and 6 months | Investigation of changes in serum level of markers related to weight loss, inflammation and muscle hypertrophy |
| Maximal muscle strength | Baseline, 3 months and 6 months | Isometric and isokinetic muscle dynamometry |
| Stair climbing capacity | Baseline, 3 months, 6 months | — |
| Jumping capacity | Baseline, 3 months, 6 months | Counter Movement Jumps |
| Chair rise capacity | Baseline, 3 months, 6 months | 30 s chair rise |
| 30 s arm curl capacity | Baseline, 3 months, 6 months | — |
Countries
Denmark
Outcome results
None listed