To examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care.
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective: To examine the impact of a supervised training program on
disease-related quality of life in patient with advanced prostate cancer
compared to usual care.
Secondary outcome
Secondary objective: Assessment of the effectiveness of a supervised training
program on cardiopulmonary fitness and body composition in patients with
metastatic prostate cancer compared to usual care.
Background summary
Past decades, the incidence of prostate cancer has more than tripled with a
prevalence of nearly 90.000 men in the Netherlands. Fifteen percent is
primarily diagnosed with advanced prostate cancer. Androgen Deprivation Therapy
(ADT) is the cornerstone treatment for these patients. However, treatment
exposes patients to a host of important adverse effects such as loss of quality
of life, loss of physical fitness, decrease in muscle and bone mass and
psychological complaints. In addition, patients experience direct negative
effects of the bone metastasis such as fatigue, (bone) pain, hypercalcaemia and
pathological fractures. In patients with localized prostate disease, a
structured, supervised training program is an effective and safe method to
improve quality of life and physical functioning. In vivo research suggests
that physical activity may slow progression of osseous metastatic disease.
Therefore, a structural training program is seen as potentially effective and
meaningful adjuvant therapy in patients with metastatic prostate carcinoma with
an improvement in physical fitness, disease-related quality of life and an
increase in muscle and bone mass.
Study objective
To examine the impact of a supervised training program on disease-related
quality of life and physical fitness in patient with advanced prostate cancer
compared to usual care.
Study design
Patients will be recruited by invitation of their cancer specialist (urologist)
who will provide clinically eligible patients with a study information sheet
and refer these patients to a study coordinator (sport physician).
In a single blinded (investigators blinded to group allocation) randomized
controlled pilot, conducted in the CWZ, 20 patients with advanced prostate
cancer will be randomized across: 1) supervised training program for twelve
weeks + usual care, or 2) usual care.
Intervention
Supervised training program: The training program will be set at the hospital
under the supervision of a physiotherapist. The intervention will consist of
combined aerobic and resistance training twice a week for 3 months (12 weeks).
In addition, patients are advised to walk or cycle for at least half an hour a
day.
Study burden and risks
It will be a burden in particular in terms of time. Patients must come to the
hospital twice a week for a supervised exercise. It has already been shown in
the literature that this patient population can safely participate in
physiotherapy.
Weg door Jonkerbos 100
Nijmegen 6532SZ
NL
Weg door Jonkerbos 100
Nijmegen 6532SZ
NL
Listed location countries
Age
Inclusion criteria
Signed informed consent
Age > 18 years old
Able to read and complete questionnaires in Dutch
Proven histologically and /or radiologically metastatic prostate cancer
(TxNxM1)
Exclusion criteria
Other cancers
Clinicians* judgement
Age >80 years old or not able to walk 400m
Structural exercise (moderate-intensity exercise more than 150 minutes a week)
during the past 3 months
Musculoskeletal, cardiovascular, or neurological disorders that could inhibit
them from exercising
Spinal cord compression, history of pathological fractures
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL80355.091.22 |