Patient Recorded Indexing Measurements

Cancer Clinical Trial

— PRIMs  

Official title:

Patient Recorded Indexing Measurements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899205
• Other study ID #: NL65402.068.18
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: Academisch Ziekenhuis Maastricht
• Contact: Nicole Hildebrand, M.D.
• Phone: +31 (0)43-3881584
• Email: nicole.hildebrand[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Cachexia
• Cancer
• Weight, Body

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht
Netherlands	Zuyderland Medical Center	Sittard

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Ziekenhuis Maastricht	Maastricht University, Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Accelerometry data on three axes	through treatment, average of 5-14 weeks
Primary	Body weight	At home measurement with memory integrated weight scale	through treatment, average of 5-14 weeks
Primary	Treatment outcome	Treatment outcome will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST)	through treatment, average of 5-14 weeks
Primary	Change in body composition (adipose tissue surface and muscular tissue surface)	Automated segmentation of body composition on the L3 level of abdominal CT-scans	through treatment, average of 5-14 weeks
Primary	Number of treatment-related adverse events as assessed by CTCAE v5.0	Chemotoxicity according to Common Toxicity Criteria v5.0	through treatment, average of 5-14 weeks
Primary	Postoperative complications	Postoperative complications rated according to Clavien-Dindo classification	30 days postoperatively
Secondary	Functional mobility/muscle strength	Timed up and go test (in sec)	2-4 weeks before treatment start
Secondary	Functional mobility	2 minute walking test (in m)	2-4 weeks before treatment start
Secondary	Muscle strength	Grip strength analysis (in kg)	2-4 weeks before treatment start
Secondary	Aerobic capacity	Steep ramp test (in W)	2-4 weeks before treatment start
Secondary	Nutritional status	Weight loss before diagnosis	2-4 weeks before treatment start
Secondary	Overall survival	Overall and recurrence free survival	Up to 5 years after completion
Secondary	Recurrence free survival	Recurrence free survival	Up to 5 years after completion