The primary objective of this study is to obtain accurate data regarding physical activity and body weight loss over time in patients with cancer who are undergoing primary curative cancer treatment (chemotherapy or surgery) and relate this to…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to obtain accurate data regarding
physical activity and body weight loss over time in patients with cancer, who
are undergoing primary curative cancer therapy (surgery or chemotherapy), and
relate this to adverse events of their treatment (postoperative complications
and/or chemotoxicity).
Secondary outcome
1) Evaluation of the association between body weight and physical activity in
patients with cancer receiving primary curative cancer treatment.
2) evaluation of the association between body weight changes, physical activity
and body composition analysis in relation to survival in patients with cancer.
3) Evaluation of the association between body weight changes, physical activity
and body composition analysis in relation to radiological or pathological
treatment response in patients with cancer
Background summary
Cancer induced cachexia is a complex condition comprising adipose tissue- and
muscle wasting due to several metabolic imbalances. Cachexia has been
associated with higher mortality, higher chemotherapy induced toxicity and
worse outcome after surgery, thus impacting cancer treatment and outcome
vastly. In cancer patients, cachexia is hallmarked by a rise in energy
expenditure. Sadly, combatting cancer cachexia-related wasting with nutritional
supplementation and dietary counseling has proven to be unsuccessful.
Furthermore, due to bias related to inherent subjective self-reporting,
currently available data on body weight-loss are inaccurate. Developing a
detailed and accurate understanding of patient activity and weight loss are
paramount as they form the basis of the consensus definition of cancer
cachexia. Moreover, this understanding will supply a blueprint for the
development of an effective treatment algorithm for cancer induced cachexia. By
investigating the relationship between these data and adverse events of
treatment (postoperative complications and/or chemotoxicity), future research
might be able to prevent these problems.
Study objective
The primary objective of this study is to obtain accurate data regarding
physical activity and body weight loss over time in patients with cancer who
are undergoing primary curative cancer treatment (chemotherapy or surgery) and
relate this to adverse events of treatment (postoperative complications and/or
chemotoxicity).
Study design
Observational
Study burden and risks
There are some small risks involved in participating in this study. One blood
sample will be taken. A venipuncture has a small risk of a small local
hematoma. Patients are screened during regular pre-operative consultation of
their physician. Screening consists of the Timed Up and GO test, Chair stand
test, 2 minute walking test, grip strength analysis, steep ramp test and short
nutritional assessment procedure. Screening is done by an experienced
physiotherapist to acquire accurate baseline data. Since this procedure is
already part of regular treatment and is supervised by an experienced
physiotherapist there is no risk nor extra burden associated with these tests.
Patients will be monitored for activity and weight in their home situation. A
wrist-worn accelerometer, memory integrated weight scale and food diary will be
used to acquire data on physical activity and weight. There is no risk
associated with this monitoring. There is however a slight burden for patients
participating. The wrist-worn accelerometer will be worn 24/7.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18
• Diagnosed with cancer
• Planned for primary curative cancer treatment (surgery or chemotherapy)
Exclusion criteria
• ASA-classification V,
• severe liver cirrhosis Child grade C,
• end stage renal disease requiring dialysis,
• severe heart disease New York Heart Association class IV,
• chronic obstructive pulmonary disease (COPD) requiring (home)oxygen therapy,
• Patients must be *mobile*. They may not be bedridden or in a wheelchair.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL65402.068.18 |