Trial Title:
Patient Recorded Indexing Measurements
NCT ID:
NCT05899205
Condition:
Cachexia
Cancer
Weight, Body
Conditions: Official terms:
Wasting Syndrome
Cachexia
Body Weight
Conditions: Keywords:
Cancer cachexia
Physical activity
Body weight
Body composition
Functional mobility
Pre-treatment assessment
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Rationale: One of the greatest challenges in the field of cancer treatment is cachexia, a
multifactorial syndrome characterized by substantial loss of body weight (muscle and fat
mass), leading to progressive functional impairment. Cancer cachexia significantly
impairs quality of life and survival as well as treatment outcome. Despite its
considerable relevance for the prognosis of cancer patients, the diagnosis of cachexia is
problematic. The current consensus definition of cancer cachexia is based on weight loss
over the last six months. In practice, this is assessed by subjective reporting by the
patient, which is subject to error and bias. Novel technologies enable accurate,
standardized, and objective assessment of body weight and physical activity by newly
diagnosed cancer patients in the home situation. Because of the increasing implementation
of neo-adjuvant treatment strategies that offer an extended time-window for the
collection of these data, there is a great opportunity to use this information in risk
analyses by treating physicians, optimization of pre-habilitation programs, and in the
shared-decision making process with the patient.
Objective: The primary objective of this study is to obtain accurate data regarding
physical activity, body composition, and body weight loss over time in patients with
gastric, esophageal, rectal, pancreatic, or ovarian cancer in relation to treatment
outcome, adverse events (chemotoxicity and/or surgical complications), and survival.
Study design: Explorative pilot study
Study population: Patients between 18 and 80 years old undergoing surgical resection or
neo-adjuvant chemotherapy for the treatment of gastric, esophageal, rectal, ovarian, or
pancreatic cancer.
Main study parameters/endpoints: Objective data acquisition on activity (three axis
acceleromotion using a wrist-worn accelerometer), body weight (at home measurement with
memory integrated weight scale), and body composition in relation to treatment outcome,
evaluated using RECIST, adverse events, assessed via chemotoxicity and surgical
complications using the Clavien-Dindo classification, and length of hospital stay in
gastric, esophageal, rectal, pancreatic, and ovarian cancer patients.
Secondary endpoints: To assess body weight changes and physical activity in relation to
survival.
Detailed description:
Patients requiring neo-adjuvant chemotherapy or primary surgery for pancreatic,
esophageal, gastric, ovarian, or colorectal cancer will be included. Patients will
undergo extensive pre-treatment screening, and then receive a weight scale for daily
at-home measurements of body weight and an accelerometer for assessing physical activity.
Body weight data will be collected using an electronic weight scale with integrated
memory SD cards for automated autonomous storage of data (CE licensed). Physical activity
will be monitored through a research grade wrist-worn accelerometer that records movement
in three axes as well as body position (sedentary versus standing position). Data on
frequency, intensity, and duration of activity will be collected. Activity can be
summarized into light, moderate and (very) vigorous activity. Additionally, data on
sedentary behavior will be collected.
Monitoring plan for patients treated with chemotherapy:
T0 Start of monitoring: When patients first present at the outpatient clinic, they will
receive extensive physical analysis by a trained physiotherapist. The screening will
consist of the following: Timed Up and Go test, Chair stand test, 2-minute walking test,
hand grip strength test, steep ramp test, and short nutritional assessment procedure.
This screening is already part of clinical routine and pre-operative screening for
extensive abdominal surgery at the MUMC+. Additionally, the investigators will collect
one blood sample. Patients will receive equipment (weight scale and accelerometer) for at
home monitoring. The patient will start using the weight scale daily and wear the
accelerometer continuously after screening.
T1: Start of chemotherapy: During chemotherapy, the body weight and physical activity
measurements will continue. Patients will use the scale once daily and the accelerometer
continuously. Chemotherapy related outcomes will be recorded during routine patient
contacts, including treatment toxicity, intensity, and outcome as monitored according to
the Common Toxicity Criteria version 5.0 and by assessing dose index (received cumulative
dose/planned cumulative dose) and time index (planned duration of therapy/actual duration
of therapy). Treatment outcome will be evaluated using the Response Evaluation Criteria
In Solid Tumors (RECIST).
T2: End of chemotherapy: The monitoring will continue until two weeks after chemotherapy.
T3: End of monitoring (at routine follow-up by senior surgeon, usually 2-3 weeks after
completion of chemotherapy). A routine CT-scan to assess the effect of the chemotherapy
will be performed. Body composition analysis at the L3-level will be used to assess the
cross-sectional area and radiation attenuation of skeletal muscle (SM), subcutaneous
adipose tissue (SAT), visceral adipose tissue (VAT), and intramuscular adipose tissue.
This will be done using automated segmentation. Patients will hand in all equipment to
the researcher during regular follow-up.
Monitoring plan for patients treated with surgery:
T0 start of monitoring: When patients first present at the outpatient clinic, they will
receive extensive physical analysis by a trained physiotherapist. The screening will
consist of the following: Timed Up and Go test, Chair stand test, 2-minute walking test,
hand grip strength analysis, steep ramp test, and short nutritional assessment procedure.
This screening is already part of clinical routine and pre-operative screening for
extensive abdominal surgery at the MUMC+. Additionally, the investigators will collect
one blood sample. Patients will receive equipment (weight scale and accelerometer) for at
home monitoring. The patient will start using the weight scale daily and wear the
accelerometer continuously.
T1: Hospital admission:
At the day of admission, the patient will not bring the weight scale and accelerometer to
the hospital. Monitoring will be paused for the length of hospital stay for primary
surgery. Postoperative complications will be recorded according to the Clavien-Dindo
classification.
T2: Discharge from hospital:
At the day of discharge after primary surgery, length of stay at the hospital will be
recorded. The patient will be reminded to restart monitoring and use the weight scale
daily and wear the accelerometer continuously.
T3: End of monitoring:
During the regular follow-up visit 2-3 weeks after discharge, monitoring will end.
Patients will hand in all equipment to the researcher during the regular follow-up visit.
Over the course of the oncological follow-up, a routine CT-scan will be performed. Body
composition analysis at the L3-level will be used to assess the cross-sectional area and
radiation attenuation of skeletal muscle (SM), subcutaneous adipose tissue (SAT),
visceral adipose tissue (VAT), and intramuscular adipose tissue. This will be done using
automated segmentation.
The investigators will obtain blood samples twice during this period at T0 and just prior
to incision on the day of surgery (T1) to analyse HbA1c, haemoglobin, CRP, TNF-α,
interleukin-6, blood lipids, and additional parameters related to inflammation. No
diagnostic procedures or treatment will be postponed.
Criteria for eligibility:
Study pop:
Adults, requiring neo-adjuvant chemotherapy or primary surgery for pancreatic,
colorectal, ovarian, gastric, or esophageal cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥ 18
- Diagnosed with gastric, esophageal, colorectal, ovarian, or pancreatic cancer
- Planned for primary surgery or neo-adjuvant 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Maastricht University Medical Center+
Address:
City:
Maastricht
Zip:
6200MD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Nicole Hildebrand, M.D.
Email:
nicole.hildebrand@mumc.nl
Facility:
Name:
Zuyderland Medical Center
Address:
City:
Sittard
Zip:
6162 BG
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Misha Sier, M.D.
Email:
m.sier@zuyderland.nl
Start date:
June 1, 2021
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Academisch Ziekenhuis Maastricht
Agency class:
Other
Collaborator:
Agency:
Zuyderland Medisch Centrum
Agency class:
Other
Collaborator:
Agency:
Maastricht University
Agency class:
Other
Source:
Academisch Ziekenhuis Maastricht
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05899205
