Back to resultsFrailty Syndrome of Post-cancer Treatment Eldery Patients (PANACEE)
Primary Purpose
Frailty Syndrome, Exercise, Nutritional Support
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
exercise and nutritional support
Sponsored by
About this trial
This is an interventional prevention trial for Frailty Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- CHU de GrenobleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exercise and nutritional support
Arm Description
exercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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)
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)
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
Estimation of adherence to nutritional interventions
comparison between active support phase and empowerment phase with food self-questionnaire
Measure the durability of long-term activities
number of monthly patient connections to heart rate monitor; evaluation of the completion of patient notebook
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).
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.
Full Information
NCT ID
NCT04746768
First Posted
November 26, 2020
Last Updated
June 3, 2021
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04746768
Brief Title
Frailty Syndrome of Post-cancer Treatment Eldery Patients
Acronym
PANACEE
Official Title
Impact of Exercise and Nutritional Support on the Frailty Syndrome of Eldery Patients in Phase of Post-cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Decrease the prevalence of frailty syndrome in individuals with complete response of cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty Syndrome, Exercise, Nutritional Support, Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise and nutritional support
Arm Type
Experimental
Arm Description
exercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months)
Intervention Type
Combination Product
Intervention Name(s)
exercise and nutritional support
Intervention Description
exercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months)
Primary Outcome Measure Information:
Title
Change of the prevalence of frailty syndrome in individuals with complete response of cancer
Description
evolution of individual frailty during a multimodal intervention (physical and nutritional activity) according to the Fried's criteria
Time Frame
0, 6 and 12 months
Secondary Outcome Measure Information:
Title
evaluation of predicitive variables of frailty syndrome reversion
Description
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.
Time Frame
Month 0, 6 and 12
Title
Correlations between physical performance and frailty syndrome and their evolutions
Description
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)
Time Frame
Month 0, 6 and 12
Title
Change from baseline nutritional status during nutritionist support (month 3 and 6) and at the end of empowerment (month 12)
Description
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)
Time Frame
Month 0, 3, 6 and 12
Title
Measure adherence to APA interventions and exercise practices
Description
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
Time Frame
between month 1 to 6 and between month 6 to 12
Title
Estimation of adherence to nutritional interventions
Description
comparison between active support phase and empowerment phase with food self-questionnaire
Time Frame
Month 6 and 12
Title
Measure the durability of long-term activities
Description
number of monthly patient connections to heart rate monitor; evaluation of the completion of patient notebook
Time Frame
Month 6 and 12
Title
Measure health related quality of life on mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression
Description
Assessment of quality of life with EQ-5D questionnaire by comparison to the basal state (M0).
Time Frame
Month 0, 6 and 12
Title
Sociological study on motivation: evaluation of the perception and experience of treating patients
Description
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.
Time Frame
Month 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaëtan Gavazzi, MD, PhD
Phone
(0)476765421
Ext
+33
Email
ggavazzi@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Mouret, PhD
Phone
(0)476767081
Ext
+33
Email
smouret1@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaëtan Gavazzi, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Frailty Syndrome of Post-cancer Treatment Eldery Patients
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