Patient Recorded Indexing Measurements

NCT05899205 | Recruiting DMC

• 1 other identifier: NL65402.068.18
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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 central aim of the 'Patient-Recorded Indexing MeasurementS' (PRIMS) study is to improve the accuracy of the diagnosis of cachexia in patients with cancer. This aim will be achieved by focusing on two objectives. The primary objectives are to compare self-reported and objectively measured pre-treatment weight change. The secondary objectives are to define host phenotypes and to investigate longitudinal associations between body weight and physical activity patterns. Study design: Explorative pilot study Study population: Patients ≥18 years old undergoing curative-intent chemotherapy or surgery for cancer. Patients will be included in two referral centers specialized in treatment of patients with upper gastrointestinal, hepatobiliary, pancreatic, colorectal, and ovarian cancer. Main study parameters/endpoints: The primary endpoint is body weight change over time. Objectively measured body weight will be compared to subjectively reported body weight change. Their respective association with treatment-related adverse events and survival will be investigated. Survival will be calculated from date of start of treatment until death. Chemotherapy related adverse event will be recorded using the Common Terminology Criteria for Adverse Events. Postoperative adverse events will be scored according to the Clavien-Dindo classification. Secondary endpoints: The secondary endpoints will be the association between other cachexia-related parameters that are investigated in the study and adverse events / survival. Other parameters include physical activity over time, using accelerometry, baseline physical assessment, anthropometric measurements, body composition, and laboratory results. Besides this, other endpoints that will be assessed are disease-free survival (calculated from the first day of treatment until first recurrence) and response to chemotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Conditions

Cachexia; Cancer; Weight, Body

Keywords

Cancer cachexia; Physical activity; Body weight; Body composition; Functional mobility; Pre-treatment assessment

Outcome Measures

Primary Outcomes (3)

• Body weight

  At home measurement with memory integrated weight scale

  throughout treatment, average of 5-14 weeks

• Number of treatment-related adverse events as assessed by CTCAE v5.0

  Chemotoxicity according to Common Toxicity Criteria v5.0

  throughout treatment, average of 5-14 weeks

• Postoperative complications

  Postoperative complications rated according to Clavien-Dindo classification

  30 days postoperatively

Secondary Outcomes (10)

• Functional mobility/muscle strength

  2-4 weeks before treatment start

• Functional mobility

  2-4 weeks before treatment start

• Change in body composition (adipose tissue surface and muscular tissue surface)

  throughout treatment, average of 5-14 weeks

• Treatment outcome

  after completion of chemotherapy, 5-14 weeks after start of treatment

• Physical activity

  throughout treatment, average of 5-14 weeks

Study Arms (5)

Periampullary and pancreatic cancer

Patients undergoing curative-intent treatment for periampullary or pancreatic cancer.

Upper-GI Cancer

Patients undergoing curative-intent treatment for esophageal or gastric cancer

Lower-GI Cancer

Patients undergoing curative-intent treatment for colorectal cancer or colorectal liver metastases

Hepatic cancer

Patients undergoing curative-intent treatment for hepatocellular carcinoma or intrahepatic or perihilar cholangiocarcinoma

Gynecological cancer

Patients undergoing curative-intent treatment for ovarian, cervical, and endometrial cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults, requiring neo-adjuvant chemotherapy or curative-intent surgery for cancer

You may qualify if:

• Age ≥ 18
• Diagnosed with cancer
• Planned for curative-intent surgery or neo-adjuvant chemotherapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead
• Zuyderland Medisch Centrum: collaborator
• Maastricht University: collaborator

Study Sites (2)

Maastricht University Medical Center+

Maastricht, 6200MD, Netherlands

RECRUITING

Zuyderland Medical Center

Sittard, 6162 BG, Netherlands

RECRUITING

Related Publications (42)

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  PMID: 41087985 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be freezed at -80°C and will be stored for 15 years and analyzed if new insights related to this research should arise.

MeSH Terms

Conditions

Cachexia; Neoplasms; Body Weight; Motor Activity

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Behavior

Study Officials

• Steven Olde Damink, PhD, MSc., M.D.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Hildebrand, M.D.

CONTACT

+31 (0)43-3881584; nicole.hildebrand@mumc.nl

Sander Rensen, PhD

CONTACT

+31 (0)43-3881584; s.rensen@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: June 12, 2023
• Study Start: June 1, 2021
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

NL (2)