Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology (DParcoursDig)

Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology - DISSPO Parcours Dig' Study

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.

Study Overview

• Status: Completed
• Conditions: Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma); Colorectal With Associated Risk Factors
• Intervention / Treatment: Other: multidisciplinary assessment and intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed and dated informed consent,
2. Age ≥ 18 years (no superior limit),
3. Histologically confirmed (1) non-colorectal cancer (esophagus, stomach, liver/bile ducts, pancreas, neuroendocrine carcinoma) or (2) colorectal with associated risk factors i.e. ECOG PS 2 (defining significant limitation in daily activities), and/or weight loss ≥ 5% in 1 month or ≥ 10% in 6 months (defining malnutrition/HAS 2019),
4. Advanced disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed), treated with first-line chemotherapy for advanced disease (previous [neo]adjuvant chemo[radio]therapy allowed); or resectable/potentially resectable disease receiving a triplet chemotherapy regimen in a peri-operative setting (e.g. FOLFIRINOX, FLOT) (moderate risk at frailty score)
5. Patients able to attend for administration of chemotherapy,
6. Life expectancy ≥ 3 months,
7. Registration in a National Health Care System (Couverture Maladie Universelle [CMU] included).

Exclusion Criteria:

1. Other active non gastro-intestinal cancers
2. Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
3. Pregnancy or breastfeeding,
4. Protected adults (individuals under guardianship by court order).

Note: participation to another concomitant clinical trial is allowed, but the patient must inform the Investigator and get an authorization from the Sponsor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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 intravenous contrast injection every 8 weeks. Nutritional support will consist of: A nutrition assessment by a dieticianat W4 and W8 (plus additional visits if required),; Nutritional intervention ± oral supplementation, enteral tube feeding, and/or parenteral nutrition). Physical activity support will consist of: A physical condition assessment by a APA profesional including physical tests (6-minute walking test, handgrip test, chair stand fitness test, get-up and go test, balance in single-leg and bipodal stance) at baseline, W4 and W8,; Personalized counselling for unsupervised home-based exercises

Other: multidisciplinary assessment and intervention; early multidisciplinary assessment and intervention in addition to usual patient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Study Chair: Véronique GILLON, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: advanced gastrointestinal (GI) cancers
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Carcinoma, Neuroendocrine
• Other Study ID Numbers: IC 2020-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No