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

Decrease the prevalence of frailty syndrome in individuals with complete response of cancer.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Exercise; Frailty Syndrome; Nutritional Support
• Intervention / Treatment: Combination product: exercise and nutritional support

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaëtan Gavazzi, MD, PhD; Phone Number: +33 (0)476765421; Email: ggavazzi@chu-grenoble.fr
• Study Contact Backup: Name: Stéphane Mouret, PhD; Phone Number: +33 (0)476767081; Email: smouret1@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • CHU de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise and nutritional support; exercise 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; exercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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)	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	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	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	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).	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.	Month 6 and 12

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Gaëtan Gavazzi, MD, PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Frailty
• Other Study ID Numbers: 38RC19.144

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No