Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: OBSERVATIONAL
Official Title: Patient Recorded Indexing Measurements
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.