PRIMs: Patient Recorded Indexing Measurements

Sponsor

Academisch Ziekenhuis Maastricht (Other)

Overall Status

Recruiting

CT.gov ID

NCT05899205

Collaborator

Zuyderland Medisch Centrum (Other), Maastricht University (Other)

300

Enrollment

Locations

Anticipated Duration (Months)

150

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cachexia Cancer Weight, Body

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Patient Recorded Indexing Measurements

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Outcome Measures

Primary Outcome Measures

Physical activity [through treatment, average of 5-14 weeks]
Accelerometry data on three axes
Body weight [through treatment, average of 5-14 weeks]
At home measurement with memory integrated weight scale
Treatment outcome [through treatment, average of 5-14 weeks]
Treatment outcome will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST)
Change in body composition (adipose tissue surface and muscular tissue surface) [through treatment, average of 5-14 weeks]
Automated segmentation of body composition on the L3 level of abdominal CT-scans
Number of treatment-related adverse events as assessed by CTCAE v5.0 [through treatment, average of 5-14 weeks]
Chemotoxicity according to Common Toxicity Criteria v5.0
Postoperative complications [30 days postoperatively]
Postoperative complications rated according to Clavien-Dindo classification

Secondary Outcome Measures

Functional mobility/muscle strength [2-4 weeks before treatment start]
Timed up and go test (in sec)
Functional mobility [2-4 weeks before treatment start]
2 minute walking test (in m)
Muscle strength [2-4 weeks before treatment start]
Grip strength analysis (in kg)
Aerobic capacity [2-4 weeks before treatment start]
Steep ramp test (in W)
Nutritional status [2-4 weeks before treatment start]
Weight loss before diagnosis
Overall survival [Up to 5 years after completion]
Overall and recurrence free survival
Recurrence free survival [Up to 5 years after completion]
Recurrence free survival