Frailty Syndrome of Post-cancer Treatment Eldery Patients
PANACEE
Impact of Exercise and Nutritional Support on the Frailty Syndrome of Eldery Patients in Phase of Post-cancer Treatment
1 other identifier
interventional
100
1 country
1
Brief Summary
Decrease the prevalence of frailty syndrome in individuals with complete response of cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedStudy Start
First participant enrolled
May 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedJune 8, 2021
February 1, 2021
1.7 years
November 26, 2020
June 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
0, 6 and 12 months
Secondary Outcomes (8)
evaluation of predicitive variables of frailty syndrome reversion
Month 0, 6 and 12
Correlations between physical performance and frailty syndrome and their evolutions
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)
Month 0, 3, 6 and 12
Measure adherence to APA interventions and exercise practices
between month 1 to 6 and between month 6 to 12
Estimation of adherence to nutritional interventions
Month 6 and 12
- +3 more secondary outcomes
Study Arms (1)
exercise and nutritional support
EXPERIMENTALexercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months)
Interventions
exercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patient with active cancer or any other pathology affecting the prognosis at 5 years
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Grenoble
Grenoble, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gaëtan Gavazzi, MD, PhD
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2020
First Posted
February 10, 2021
Study Start
May 4, 2021
Primary Completion
January 1, 2023
Study Completion
January 1, 2024
Last Updated
June 8, 2021
Record last verified: 2021-02