Personalized Cooking and Nutrition Guidance and Physical Activities Program to Reduce Muscle Loss in Advanced Cancer

Official title

CuliCan Study A Multimodal Approach to Mitigate Muscle Mass Loss in Advanced Cancer Patients: Personalized Culinary Advice Addressing Mild to Moderate Muscle Mass Loss

Overview

People with advanced cancer often lose muscle over time. This can make them weaker, more tired, and reduce their quality of life. Many patients also struggle to eat because of changes in taste, smell, or appetite. This study evaluates a new way to help slow muscle loss and support daily functioning. The approach combines personalized food and cooking guidance with close nutrition demands support. The goal is to help patients eat better in a way that fits their personal needs. It is hypothesized that this close, personalized treatment improves muscle loss and the quality of life of adults with advanced cancer who are receiving chemotherapy. The study focuses on people with mild to moderate muscle mass loss currently undergoing or about to start chemotherapy and aims to slow further decline in their muscle mass. The approach is designed to be practical and suitable for everyday life during cancer treatment. About 200 adults with advanced cancer who are receiving, or about to receive, chemotherapy will take part in this study. The study will take place at the Davidoff Cancer Center in Israel and will last 6 months. Participants will be randomly assigned to one of two groups. One group will receive standard nutrition care from dietitians as well as ongoing physical activities programing and monitoring. The other group will receive the same care, plus personalized cooking and food guidance tailored to their taste and smell changes. This group will also receive care based on careful measurements of their body's energy needs, body composition, and muscle strength. These measurements will help the dietitian to offer more precise and personalized nutrition guidance over time. Both groups will also receive advice about physical activity. Researchers will follow changes in muscle strength, physical function, nutrition status, and quality of life during the study. The results will help determine whether personalized food and cooking support can better protect muscle mass and well-being in people with advanced cancer.

Detailed description

After the completion of 20 patients in each group, an interim analysis will be performed to evaluate the safety and efficacy of the study. The following committee members will evaluate the results and determine whether the study should continue: Prof. Ilya Kagan, MD, Prof. Carla Prado, PhD, RD, FCAHS and Dr. Noa Gordon, PhD.

Interventions

• Behavioral Oncology Dietitian's Standard of Care
  Standard-of-care dietary management for cancer patients.
• Behavioral Personalized Culinary and Nutrition Therapy
  Personalized culinary advice based on each patient's specific taste and smell profile, along with close monitoring and management of the patient's metabolism (resting energy expenditure, body composition, and hand strength) for ±6 months.

Primary outcome measures

• Muscle mass loss, assessed by SMI on CT examination, from baseline throughout the 6-month study period. CT scans obtained within a window of up to 2 months after completion of the participant's study participation may be used. [Time frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes. CT scans obtained within a window of up to 2 months after completion of the participant's study parti]
• General quality of life, assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), from baseline throughout the 6-month study period. [Time frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.]
• General quality of life assessed by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT), from baseline throughout the 6-month study period. [Time frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.]
• Food-related quality of life, assessed by the QVA Questionnaire (from the French "Qualité de Vie Alimentaire"), from baseline throughout the 6-month study period. [Time frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.]

Secondary outcome measures (5)

• Muscle function evaluated using handgrip (HG), from baseline throughout the 6-month study period. [Time frame: From baseline throughout the month 6 study period - repeatedly evaluate across the study period between groups and within patient longitudinal changes.]
• Muscle function evaluated using the 6-minute walk (6MW) test, from baseline throughout the 6-month study period. [Time frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.]
• Muscle function evaluated using the sit-to-stand (STS) test, from baseline throughout the 6-month study period. [Time frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.]
• Muscle function evaluated using the time up and go (TUG) test, from baseline throughout the 6-month study period. [Time frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.]
• Hospitalization rate throughout the 6-month study period. [Time frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.]

Eligibility criteria

Inclusion criteria

• Ambulatory males and females, age ≥ 18 years
• Performance status (PS) 0-2
• Patients with non-occlusive, metastatic malignancies of the gastrointestinal, lung, genitourinary, or breast origin (stage 4)
• Receiving/about to receive chemotherapy treatment
• Have an estimated life expectancy of at least 6 months
• At least 4 weeks post major surgery
• Mild to moderate muscle mass loss based on the SMI measure on compoCT
• At risk of malnutrition according to the 'Malnutrition Universal Screening Tool' (MUST) (Score ≥2)
• Able to understand and provide written informed consent
• Willing and able to complete all study-specific procedures and visits
• Willing and able (either personally or with the help of family members) to prepare meals according to the adjusted recipes

Exclusion criteria

• Patients suffering from gastrointestinal obstruction
• Patients with severe dietary restrictions
• A medical condition that impacts the ability to increase muscle mass, as per the PI decision
• Uncontrolled thyroid disease
• Self-reported major dietary restrictions related to the intervention, such as irritable bowel syndrome (IBS)
• Patients with a history or active eating disorder
• Pregnant or lactating

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Israel · 1 center

• Davidoff Center of Cancer, Rabin Medical Center — Petah Tikva

Identifiers

NCT: NCT07466862 · 0514-25-RMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗