Frailty SyndromePANACEENCT04746768
Frailty Syndrome of Post-cancer Treatment Eldery Patients
A study testing exercise and nutritional support in people with Frailty Syndrome and Exercise, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Decrease the prevalence of frailty syndrome in individuals with complete response of cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty Syndrome, Exercise, Nutritional Support
- What is being tested?
- exercise and nutritional support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2021to Jan 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- in complete remission from cancer (all type of cancer)
- have a frailty syndrome (positive GFST score)
- ability to provide signed informed consent
- be affiliated with social security or beneficiary of such a scheme
Who cannot join
- patient with active cancer or any other pathology affecting the prognosis at 5 years
- currently participating or having participated in the month preceding inclusion in another interventional clinical research that may impact the study. This impact is left to the investigator discretion
- subjects referred to articles L1121-5 to L1121-8 of CSP (corresponds to all protected persons: person deprived of liberty by judicial or administrative decision, person subject to legal protection measure)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Exercise and Nutritional Support on the Frailty Syndrome of Eldery Patients in Phase of Post-cancer Treatment
Decrease the prevalence of frailty syndrome in individuals with complete response of cancer.
- Conditions
- Frailty Syndrome, Exercise, Nutritional Support, Cancer
- Being tested
- exercise and nutritional support
- Medical subject headings
- Frailty, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and nutritional supportCombination product
exercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months)
| Study group | Role | What they receive |
|---|---|---|
| exercise and nutritional support | Experimental | exercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months) Receives: Combination Product: exercise and nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the prevalence of frailty syndrome in individuals with complete response of cancer
evolution of individual frailty during a multimodal intervention (physical and nutritional activity) according to the Fried's criteria
Measured: 0, 6 and 12 months
Secondary outcomes (8)
evaluation of predicitive variables of frailty syndrome reversion
The criterion determining the frail status is the Fried score classified into 3 categories: not frail; pre-frail; frail. A change from frail to pre-frail or to not frail will be considered as an improvement. Measurements of the Frailty score and other markers on nutrition and APA will be carried out at month 0 (basic measurements), then measured at month 6 (end of APA and nutritionist support) and at month12 (6 months after empowerment). All of health markers collected during the basic assessment, changes in parameters (month 6) and compliance with APA and nutrition support (from Month 1 to Month 6 then between Month 6 and Month 12) will be tested as variables potentially predictive of an improvement in the frailty syndrome.
Measured: Month 0, 6 and 12
Correlations between physical performance and frailty syndrome and their evolutions
measurement of VO2peak + ventilatory thresholds measured in a stress test, muscle strength/endurance (number of chair raises for 30 seconds), walking speed (10-meter walking test, 6-minute walk test), balance (Tinette score), coordination (functional mobility test), cardio-respiratory endurance (heart rate measurement in relation to pedaling power)
Measured: Month 0, 6 and 12
Change from baseline nutritional status during nutritionist support (month 3 and 6) and at the end of empowerment (month 12)
nutritional parameters measured at each time frame for weight, VAS appetite score, MNA score, nutritional calculation (food survey and self-questionnaire), bio impedancemetry and biomarkers of nutrition (levels of albumin, prealbumin, C reactive protein, CBC, liver and kidney function)
Measured: Month 0, 3, 6 and 12
Measure adherence to APA interventions and exercise practices
Adherence to APA support program throughout the study will be evaluated by measurements and sum of multiple parameters: number of sessions recorded on the heart rate monitor, average energy expenditure (in kcal) measured by the heart rate monitor,number of sets of exercises performed relative to the number of exercises recommended for muscle strengthening recorded in the patient notebook, CESS scale to assess beliefs about cancer patients and physical activity
Measured: between month 1 to 6 and between month 6 to 12
Estimation of adherence to nutritional interventions
comparison between active support phase and empowerment phase with food self-questionnaire
Measured: Month 6 and 12
Measure the durability of long-term activities
number of monthly patient connections to heart rate monitor; evaluation of the completion of patient notebook
Measured: Month 6 and 12
Measure health related quality of life on mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression
Assessment of quality of life with EQ-5D questionnaire by comparison to the basal state (M0).
Measured: Month 0, 6 and 12
Sociological study on motivation: evaluation of the perception and experience of treating patients
a series of qualitative interviews with a panel of 15 patients, during 2 interview sessions: 1 after support phase and 1 at the end of autonomy phase. Interview will collect past/current socio-professional life, socialization in physical activity and nutrition.
Measured: Month 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start4 May 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan Gavazzi, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746768
- Sponsor's protocol ID
- 38RC19.144
- Acronym
- PANACEE
- Status last verified
- Feb 2021
- First submitted
- 26 Nov 2020
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Drevet S, Agbogbo MA, Ghaith A, Chardon M, Guinot M, Coudurier M, Doutreleau S, Lumale S, Musso N, Petit P, Lopez C, Penkov G, El Mouzdahir E, Mouret S, Liuu E, Vuillerme N, Flore P, Gavazzi G. Improvement of frailty and prefrailty in older cancer survivors: a 6-month home-based pilot study. Age Ageing. 2026 Aug 3;55(8):afag245. doi: 10.1093/ageing/afag245.
PubMed 42621847
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise and Nutritional Support on the Frailty Syndrome of Eldery Patients in Phase of Post-cancer Treatment
- ClinicalTrials.gov ID
- NCT04746768
- Acronym / sponsor ID
- PANACEE / 38RC19.144
- Conditions
- Frailty Syndrome, Exercise, Nutritional Support, Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 10 Feb 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.
Decrease the prevalence of frailty syndrome in individuals with complete response of cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise and nutritional support | Experimental | Combination Product: exercise and nutritional supportexercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- in complete remission from cancer (all type of cancer)
- have a frailty syndrome (positive GFST score)
- ability to provide signed informed consent
- be affiliated with social security or beneficiary of such a scheme
Key exclusion criteria (3 listed)
- patient with active cancer or any other pathology affecting the prognosis at 5 years
- currently participating or having participated in the month preceding inclusion in another interventional clinical research that may impact the study. This impact is left to the investigator discretion
- subjects referred to articles L1121-5 to L1121-8 of CSP (corresponds to all protected persons: person deprived of liberty by judicial or administrative decision, person subject to legal protection measure)
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 |
|---|---|---|
| exercise and nutritional supportexercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months) | Combination product | exercise and nutritional support |
Primary outcome
Change of the prevalence of frailty syndrome in individuals with complete response of cancer
Time frame: 0, 6 and 12 months
evolution of individual frailty during a multimodal intervention (physical and nutritional activity) according to the Fried's criteria
8 secondary outcomes
evaluation of predicitive variables of frailty syndrome reversion
Time frame: Month 0, 6 and 12
Correlations between physical performance and frailty syndrome and their evolutions
Time frame: Month 0, 6 and 12
Change from baseline nutritional status during nutritionist support (month 3 and 6) and at the end of empowerment (month 12)
Time frame: Month 0, 3, 6 and 12
Measure adherence to APA interventions and exercise practices
Time frame: between month 1 to 6 and between month 6 to 12
Estimation of adherence to nutritional interventions
Time frame: Month 6 and 12
Measure the durability of long-term activities
Time frame: Month 6 and 12
Measure health related quality of life on mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression
Time frame: Month 0, 6 and 12
Sociological study on motivation: evaluation of the perception and experience of treating patients
Time frame: Month 6 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Derived from this study: PubMed 42621847Drevet S, Agbogbo MA, Ghaith A, Chardon M, Guinot M, Coudurier M, Doutreleau S, Lumale S, Musso N, Petit P, Lopez C, Penkov G, El Mouzdahir E, Mouret S, Liuu E, Vuillerme N, Flore P, Gavazzi G. Improvement of frailty and prefrailty in older cancer survivors: a 6-month home-based pilot study. Age Ageing. 2026 Aug 3;55(8):afag245. doi: 10.1093/ageing/afag245.
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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.
Gaëtan Gavazzi, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and nutritional support in people with Frailty Syndrome and Exercise, run by University Hospital, Grenoble 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaëtan Gavazzi, MD, PhD ((0)476765421 ext. +33, ggavazzi@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the prevalence of frailty syndrome in individuals with complete response of cancer (time frame: 0, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746768, which also lists 1 linked publication.
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 8 Jun 2021.