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.

Conditions

• Cachexia
• Cancer
• Weight, Body

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

Countries

Netherlands

Locations and Investigators

• Maastricht University Medical Center+, Maastricht, Netherlands (Recruiting)
  • Nicole Hildebrand, M.D.
• Zuyderland Medical Center, Sittard, Netherlands (Recruiting)
  • Misha Sier, M.D.

Study Officials

• Steven Olde Damink, PhD, MSc., M.D. (Principal Investigator) — Maastricht University Medical Center