Cancer DigestiveDIGELECTROSTIMNCT04906954
Combined Neuromuscular Electrical Stimulation and Nutritional Support for Advanced Gastrointestinal Cancer Patients.
A study testing NMES in people with Cancer Digestive, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 1 site in France.
Trial summary
Dig' Electrostim-01 is phase II, single center (step 1) and multicentre (step 2), single-arm study to evaluate an 8-week NMES intervention combined with nutritional support in addition to usual patient care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Digestive
- What is being tested?
- NMES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2023to Dec 2024
- 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,
- Mini Nutritional Assessment (MNA) and geriatric 8 (G8) health status screening tools for patients ≥ 70 years and oncogeriatric evaluation if G8 ≤ 14,
- First-line chemotherapy for advanced disease,
- Histologically confirmed colorectal, pancreatic, esophageal, or gastric cancer (adenocarcinoma or squamous cell carcinoma),
- Metastatic disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed),
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- Patients able to receive chemotherapy,
- Eastern Cooperative Oncology Group performance status of 2,
- Life expectancy ≥ 3 months,
- Registration in a National Health Care System (Protection Universelle Maladie [PUMa] included).
Who cannot join
- Neuroendocrine histology or primary tumor other than esophageal, gastric, pancreatic, biliary, or colorectal cancer,
- Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
- Ulcerative skin lesions over the quadriceps muscle,
- Participation to another physical activity program (exercise or NMES),
- Pacemaker-depended patients,
- Albuminemia < 25 g/L,
- Pregnancy or breastfeeding,
- Protected adults (individuals under guardianship by court order or tutelage). Note: participation to another concomitant clinical trial (except for trials evaluating exercise or NMES programs) is allowed, but the patient must inform about it and get an authorization from the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support in Deconditioned Patients With Advanced Gastrointestinal Cancer - DIG'ELECTROSTIM-01
Dig' Electrostim-01 is phase II, single center (step 1) and multicentre (step 2), single-arm study to evaluate an 8-week NMES intervention combined with nutritional support in addition to usual patient care
Read the detailed description
Sarcopenia and cachexia are observed in more than 50% of patients with gastrointestinal (GI) cancer.
Both negatively affect patient survival and health-related quality of life (HRQoL) due to decreased tolerance to anticancer treatments and increased susceptibility to infections and other complications. Therefore, sarcopenia and cachexia represent a major clinical issue in this setting. A multimodal therapeutic approach to the sarcopenia and cachexia management is recommended, including nutritional support and exercise with personalized oncology care and family-centered education.
Neuromuscular electrical stimulation (NMES) generates muscle contractions using portable devices connected to surface electrodes.
NMES is safe, does not require the active cooperation of the patient and can be self-administered at home, thereby providing an acceptable physical therapy for patients with advanced cancer and an altered Eastern Cooperative Oncology Group performance status (ECOG PS) and/or a high-symptom burden, for whom attendance to hospital-based exercise training is difficult.
In this study, we hypothesize that NMES is a safe and effective physical-therapy strategy to improve HRQoL and to reduce cancer-induced sarcopenia in patients with metastatic GI cancer and altered ECOG PS (ECOG PS of 2).
- Conditions
- Cancer Digestive
- Being tested
- NMES
- Keywords
- electrostimulation
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESOther
Standardized strength program (75 Hz frequency, 40 cycles). The stimulation intensity will be increased up to the highest tolerated level in order to evoke strong muscle contractions.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation (NMES) | Other | 30 NMES sessions will be performed by patients for 30 min, for a period of 8 weeks, according to a standardized protocol.
The number of sessions per week will be gradually increased to reach 5 sessions/week at week 4. Receives: Other: NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step 1 : Number of patients who completed the neuromuscular electrical stimulation (NMES) program
Step 1: Feasibility study will be performed on the first 10 patients. The NMES adherence will be satisfactory if the patient achieves ≥ 40% of planned sessions (12 in total). The NMES will be considered feasible if ≥ 70% of the first 10 patients included achieve this goal.
Measured: At 6 months
Step 2 : Number of patients with improvement of 10 points between baseline and week 8, assessed using the EORTC QLQ-C30 physical functioning scale
At baseline, at week 8
Measured: Up to 24 months
Secondary outcomes (3)
Time between inclusion and the observation of the first deterioration of at least 10 points as compared to the baseline score
Every 2 moths until 12 months after inclusion
Measured: Up to 24 months
Progression-free survival (PFS)
PFS defined as the time between inclusion and tumor progression (according to RECIST v1.1) or death (all causes), whichever occurs first
Measured: Up to 24 months
Overall Survival (OS)
OS defined as the time between inclusion and death (from all causes)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study startSep 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: The study was not initiated due to logistical challenges, and the contract for the acquisition of the equipment-comprising relatively high-cost machinery-was never finalized.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer DigestiveStudies 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
- Model description
- Phase II
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy NEUZILLET, MD, Principal investigator, Institut Curie Site Saint Cloud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906954
- Sponsor's protocol ID
- DIG' ELECTROSTIM-01-G-097
- Acronym
- DIGELECTROSTIM
- Status last verified
- Jun 2025
- First submitted
- 25 May 2021
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support in Deconditioned Patients With Advanced Gastrointestinal Cancer - DIG'ELECTROSTIM-01
- ClinicalTrials.gov ID
- NCT04906954
- Acronym / sponsor ID
- DIGELECTROSTIM / DIG' ELECTROSTIM-01-G-097
- Conditions
- Cancer Digestive
- Keywords
- electrostimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not initiated due to logistical challenges, and the contract for the acquisition of the equipment-comprising relatively high-cost machinery-was never finalized.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 May 2021 (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.
Dig' Electrostim-01 is phase II, single center (step 1) and multicentre (step 2), single-arm study to evaluate an 8-week NMES intervention combined with nutritional support in addition to usual patient care
Detailed description
Sarcopenia and cachexia are observed in more than 50% of patients with gastrointestinal (GI) cancer.
Both negatively affect patient survival and health-related quality of life (HRQoL) due to decreased tolerance to anticancer treatments and increased susceptibility to infections and other complications. Therefore, sarcopenia and cachexia represent a major clinical issue in this setting. A multimodal therapeutic approach to the sarcopenia and cachexia management is recommended, including nutritional support and exercise with personalized oncology care and family-centered education.
Neuromuscular electrical stimulation (NMES) generates muscle contractions using portable devices connected to surface electrodes.
NMES is safe, does not require the active cooperation of the patient and can be self-administered at home, thereby providing an acceptable physical therapy for patients with advanced cancer and an altered Eastern Cooperative Oncology Group performance status (ECOG PS) and/or a high-symptom burden, for whom attendance to hospital-based exercise training is difficult.
In this study, we hypothesize that NMES is a safe and effective physical-therapy strategy to improve HRQoL and to reduce cancer-induced sarcopenia in patients with metastatic GI cancer and altered ECOG PS (ECOG PS of 2).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation (NMES) | Other | Other: NMES30 NMES sessions will be performed by patients for 30 min, for a period of 8 weeks, according to a standardized protocol. The number of sessions per week will be gradually increased to reach 5 sessions/week at week 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed and dated informed consent,
- Age ≥ 18 years,
- Mini Nutritional Assessment (MNA) and geriatric 8 (G8) health status screening tools for patients ≥ 70 years and oncogeriatric evaluation if G8 ≤ 14,
- First-line chemotherapy for advanced disease,
- Histologically confirmed colorectal, pancreatic, esophageal, or gastric cancer (adenocarcinoma or squamous cell carcinoma),
Key exclusion criteria (8 listed)
- Neuroendocrine histology or primary tumor other than esophageal, gastric, pancreatic, biliary, or colorectal cancer,
- Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
- Ulcerative skin lesions over the quadriceps muscle,
- Participation to another physical activity program (exercise or NMES),
- Pacemaker-depended patients,
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 |
|---|---|---|
| NMESStandardized strength program (75 Hz frequency, 40 cycles). The stimulation intensity will be increased up to the highest tolerated level in order to evoke strong muscle contractions. | Other | Neuromuscular electrical stimulation (NMES) |
Primary outcome
Step 1 : Number of patients who completed the neuromuscular electrical stimulation (NMES) program
Time frame: At 6 months
Step 1: Feasibility study will be performed on the first 10 patients. The NMES adherence will be satisfactory if the patient achieves ≥ 40% of planned sessions (12 in total). The NMES will be considered feasible if ≥ 70% of the first 10 patients included achieve this goal.
Step 2 : Number of patients with improvement of 10 points between baseline and week 8, assessed using the EORTC QLQ-C30 physical functioning scale
Time frame: Up to 24 months
At baseline, at week 8
3 secondary outcomes
Time between inclusion and the observation of the first deterioration of at least 10 points as compared to the baseline score
Time frame: Up to 24 months
Progression-free survival (PFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Cindy NEUZILLET, MD principal investigator
Institut Curie Site Saint Cloud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES in people with Cancer Digestive, run by GERCOR - Multidisciplinary Oncology Cooperative Group 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 10 inclusion and 8 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: withdrawn, as of the sponsor's last update on 3 Jul 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Step 1 : Number of patients who completed the neuromuscular electrical stimulation (NMES) program (time frame: At 6 months). The study lists 2 primary outcomes in all. 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 3 Jul 2025.