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2021-04-29
2022-10-05
2022-10-05
30
NCT04478175
Institut Curie
Institut Curie
INTERVENTIONAL
Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology
Patients with advanced gastrointestinal (GI) cancers are very often sarcopenic/malnourished at diagnosis (> 60% of cases) and at high risk of rapid clinical deterioration. These patients have important supportive care needs that represent a major challenge for improving treatment tolerance and patient survival and health-related quality of life (HRQoL). Malnutrition and sarcopenia (muscle wasting and dysfunction) are associated with an increased risk of death, complications from chemotherapy, infections, emergency procedures and hospitalizations, and increased costs of care. Therefore, malnutrition and sarcopenia represent a major clinical target in GI cancers. Interventions targeting malnutrition/sarcopenia should be implemented as early as possible in patients' pathways, these syndromes being reversible at early stages but not at late stages. A multidisciplinary assessment at diagnosis and therapeutic approach combining nutritional support and and adapted physical activity (APA) in addition to anticancer treatments should be systematically implemented in patients with advanced GI cancers. This type of intervention complies with the standards recommended by the National Cancer Institute (INCa) to promote the practice of physical activity during and after treatment in oncology.
All patients will receive usual care including: * Chemotherapy at the investigator's choice, * Outpatient clinical visits according to the regular schedule, * Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with intravenous contrast injection every 8 weeks. Nutritional support will consist of: * A nutrition assessment by a dietician including a VAS of food intakes at baseline, at W4 and W8 (plus additional visits if required), * Nutritional intervention according to the Société Francophone de Nutrition Clinique et Métabolisme (SFNEP) guidelines (dietetic counseling for all patients ± oral supplementation, enteral tube feeding, and/or parenteral nutrition). Physical activity support will consist of physical condition assessed by International Physical Activity Questionnaire (IPAQ), performance status (ECOG PS), resting heart rate and blood pressure, 6-minute walking test (speed, fatigue), handgrip test, chair stand fitness test, get-up and go test, balance in single-leg and bipodal stance.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-07-01 | N/A | 2022-11-16 |
2020-07-15 | N/A | 2022-11-17 |
2020-07-20 | N/A | 2022-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Patients with advanced gastrointestinal (GI) cancers All patients will receive usual care including: * Chemotherapy at the investigator's choice, * Outpatient clinical visits according to the regular schedule, * Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with intra | OTHER: multidisciplinary assessment and intervention
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Program faisability | Program feasibility will be satisfactory if ≥ 80% of patients with advanced GI cancers included in the program complete the baseline, W4 and W8 assessments | 12 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Dimensions of EORTC QLQ-C30 | EORTC QLQ-C30 completion | 12 months |
| Fatigue measured by Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) completion, a score form 0 to 10 will be given | 12 months |
| Pain measured by VAS and analgesics consumption | VAS completion and analgesics consumption report, a score form 0 to 10 will be given and report of analgesics consumption will be given by name and dose | 12 months |
| Nutritional status/inflammation measure | weight in kilograms, body mass index will be reported in BMI in kg/m^2, food intakes | 12 months |
| Physical condition assessed | International Physical Activity Questionnaire (IPAQ), | 12 months |
| Geriatric assessment if age ≥ 70 | G8 score from 0 to 17 | 12 months |
| Chemotherapy tolerance assessed | toxicities (using Common Terminology Criteria for Adverse Events [CTCAE v5.0]) | 12 months |
| Progression Free Survival and Overall Survival | Progression Free Survival and Overall Survival | 12 months |
| Patient's satisfaction measured by VAS | VAS completion with a score from 0 to 10 | 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
