Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncology Dietitian Standard of Care | Active Comparator | Patient will be treated according to the Davidoff oncology dietitian's standard of care. Patient will also receive a standard physical activity program and monitoring. |
|
| Personalized Culinary and Nutrition Therapy | Experimental | Patient will be treated according to the oncology dietitian's standard of care, including personalized culinary advice based on their individual taste and smell profile, along with close monitoring and management of their metabolism/physiologic needs (their resting energy expenditure, body composition, and hand strength). Dietitians will provide guidance using specially adapted recipes, professionally adjusted to meet individually profiled taste and smell needs, along with general science-based recommendations for meal preparation. Patient will also receive a standard physical activity program and monitoring. Sensory alterations (taste and smell) and metabolic/physiological measures (resting energy expenditure, body composition, and hand strength) will be conducted every ±3-6 weeks. Each patient will participate in the study for ±6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncology Dietitian's Standard of Care | Behavioral | Standard-of-care dietary management for cancer patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | The raw score will be transformed to a standardized range from 0 to 100, according to the EORTC scoring manual. Higher scores indicate better functioning and QoL, whereas in the symptom subscale, higher scores indicate greater symptom burden (worse outcome). | 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. | According to the FAACT scoring guidelines, the range of possible scores is 0-156, with 0 being the worst possible score and 156 the best. | 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. | The Global QVA score ranges from 35 to 140 points when the social (SOCIO) factor is included. A higher score on this scale indicates a better food-related quality of life. | From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle function evaluated using handgrip (HG), from baseline throughout the 6-month study period. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily energy provided through supplemental nutrition (oral nutritional supplements [ONS], enteral nutrition, or parenteral nutrition) across the 6-month study period, expressed as total kilocalories per day (kcal/day). | From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes. |
Inclusion Criteria:
Exclusion Criteria:
Pregnancy or lactation are exclusion criteria.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daphna Murvitz, L.L.B. | Contact | +972-52-3883885 | daphnamur@clalit.org.il | |
| Sarit Anavi Cohen, PhD | Contact | +972-50-3214030 | saritanavi@gmail.com, saritana@clalit.org.il, |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davidoff Center of Cancer, Rabin Medical Center | Petah Tikva | 49100 | Israel |
De-identified IPD will be shared upon reasonably request, subjected to approval by the steering committee and IRB regulations, and a data use agreement
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Personalized Culinary and Nutrition Therapy | Behavioral | 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. |
|
| 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. | 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. | 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. | From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D055948 | Sarcopenia |
| D005518 | Food Preferences |
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided