Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma)DParcoursDigNCT04478175
Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology
A study testing multidisciplinary assessment and intervention in people with Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma) and Colorectal With Associated Risk Factors, run by Institut Curie at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma), Colorectal With Associated Risk Factors
- What is being tested?
- multidisciplinary assessment and intervention
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2021to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent,
- Age ≥ 18 years (no superior limit),
- 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),
- 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)
- Patients able to attend for administration of chemotherapy,
- Life expectancy ≥ 3 months,
- Registration in a National Health Care System (Couverture Maladie Universelle [CMU] included).
Who cannot join
- Other active non gastro-intestinal cancers
- Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
- Pregnancy or breastfeeding,
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma), Colorectal With Associated Risk Factors
- Being tested
- multidisciplinary assessment and intervention
- Keywords
- advanced gastrointestinal (GI) cancers
- Medical subject headings
- Carcinoma, Neuroendocrine, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary assessment and interventionOther
early multidisciplinary assessment and intervention in addition to usual patient care
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced gastrointestinal (GI) cancers | Other | 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 Receives: Other: multidisciplinary assessment and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (9)
Dimensions of EORTC QLQ-C30
EORTC QLQ-C30 completion
Measured: 12 months
Fatigue measured by Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) completion, a score form 0 to 10 will be given
Measured: 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
Measured: 12 months
Nutritional status/inflammation measure
weight in kilograms, body mass index will be reported in BMI in kg/m^2, food intakes
Measured: 12 months
Physical condition assessed
International Physical Activity Questionnaire (IPAQ),
Measured: 12 months
Geriatric assessment if age ≥ 70
G8 score from 0 to 17
Measured: 12 months
Chemotherapy tolerance assessed
toxicities (using Common Terminology Criteria for Adverse Events [CTCAE v5.0])
Measured: 12 months
Progression Free Survival and Overall Survival
Progression Free Survival and Overall Survival
Measured: 12 months
Patient's satisfaction measured by VAS
VAS completion with a score from 0 to 10
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start29 Apr 2021
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique GILLON, Study chair, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478175
- Sponsor's protocol ID
- IC 2020-01
- Acronym
- DParcoursDig
- Status last verified
- Nov 2022
- First submitted
- 1 Jul 2020
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology - DISSPO Parcours Dig' Study
- ClinicalTrials.gov ID
- NCT04478175
- Acronym / sponsor ID
- DParcoursDig / IC 2020-01
- Conditions
- Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma), Colorectal With Associated Risk Factors
- Keywords
- advanced gastrointestinal (GI) cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced gastrointestinal (GI) cancers | Other | Other: multidisciplinary assessment and interventionAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed and dated informed consent,
- Age ≥ 18 years (no superior limit),
- 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),
- 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)
- Patients able to attend for administration of chemotherapy,
Key exclusion criteria (5 listed)
- Other active non gastro-intestinal cancers
- Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
- Pregnancy or breastfeeding,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary assessment and interventionearly multidisciplinary assessment and intervention in addition to usual patient care | Other | Patients with advanced gastrointestinal (GI) cancers |
Primary outcome
Program faisability
Time frame: 12 months
Program feasibility will be satisfactory if ≥ 80% of patients with advanced GI cancers included in the program complete the baseline, W4 and W8 assessments
9 secondary outcomes
Dimensions of EORTC QLQ-C30
Time frame: 12 months
Fatigue measured by Visual Analogue Scale (VAS)
Time frame: 12 months
Pain measured by VAS and analgesics consumption
Time frame: 12 months
Nutritional status/inflammation measure
Time frame: 12 months
Physical condition assessed
Time frame: 12 months
Geriatric assessment if age ≥ 70
Time frame: 12 months
Chemotherapy tolerance assessed
Time frame: 12 months
Progression Free Survival and Overall Survival
Time frame: 12 months
Patient's satisfaction measured by VAS
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique GILLON study chair
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary assessment and intervention in people with Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma) and Colorectal With Associated Risk Factors, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program faisability (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.