Head and Neck Cancer, Prostate Cancer, Rectum Cancer
Conditions
Brief summary
The aim of this study is to assess the impact of a high-intensity aerobic training and resistance training on fatigue in prostate, head and neck and rectum cancer patients undergoing radiotherapy. A three-arm randomized controlled trial will be conducted. Patients will be randomised into either a high-intensity aerobic training group or a resistance training group or a control group. Participants in the training groups will exercised for five to eight weeks. Exercise sessions will be take place 3 days per week under the supervision of an experienced therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence syndrome, insomnia, depression symptoms.
Interventions
BEHAVIORALHigh-intensity interval training
High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.
BEHAVIORALResistance training
Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * a primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer; * age over 18 years; * no distant metastases and/or disease progression; * at least 25 scheduled radiation treatments (5 weeks); * ability to read, write, and speak French.
Exclusion criteria
: * uncontrolled cardiac, hypertensive or pulmonary diseases, * uncontrolled insulin-dependent diabetes mellitus, * neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation * abnormal electrocardiogram.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue | Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer) | Fatigue is measured by FACIT-fatigue questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer) | Quality of life is measured by Functional Assessment of Cancer Therapy-General |
| Change in sleep disturbances | Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer) | Sleep disturbances are measured by Pittsburgh Sleep Quality Index |
| Change in somnolence syndrome | Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer) | Somnolence syndrome is measured by Epworth Sleepiness Scale |
| Change in insomnia | Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer) | Insomnia is measured by Insomnia Severity Index |
| Change in functional capacity | Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer) | Functional capacity is measured by 6-minute walk test |
| Change in executive functions | Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer) | Executive functions is measured by the Trail Making Test |
| Change in dyspnea | Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer) | Dyspnea is measured by Multidimensional Dyspnea Profile |
| Adherence | Weekly through the intervention (during 8 weeks) | Percentage of completed sessions |
| Change in depression symptoms | Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer) | Depression symptoms are measured by Center for Epidemiologic Studies Depression Scale |
Countries
Belgium
Outcome results
None listed