Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627595
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APiTOXMM
Brief Summary:
Management of melanoma is based on primary excision of the tumor In cases of melanoma with poor prognosis criteria or when it is locally advanced or metastatic there is an indication for the implementation of adjuvant therapy which may in this context be immunotherapy
Immunotherapies are treatments that have revolutionized the prognosis of patients with melanoma These are therapies that work by stimulating the immune system to enhance the anti-tumor response Their toxicities are represented by immune-mediated toxicities similar to true autoimmune diseases
Adapted physical activity as supportive care in oncology is expanding From a pathophysiological perspective physical activity is thought to modulate the immune system by reducing inflammation restoring immune surveillance stimulating anti-tumor responses through the induction of T cell proliferation modulating the gut microbiota and influencing tumor microenvironment cells etc
The modulation of the immune system by physical activity may also allow us to hypothesize a modulation of the toxicities induced by immune checkpoint inhibitors We wish to study this hypothesis in patients with advanced melanoma who are candidates for immunotherapy
Originality and Innovative Aspects
Physical activity as supportive care in oncology has developed significantly in recent years However adapted physical activity APA is currently only offered at one center in France CHU de Lille
In addition to the probable impact on patients39 quality of life if we find evidence supporting a reduction in treatment-related toxicities for melanoma through physical activity it would be even more interesting to introduce APA at the CHU of Montpellier
Primary and Secondary Objectives
Primary Objective To analyze the association between the level of physical activity estimated by the IPAQ questionnaire at the initiation of immunotherapy and the occurrence of adverse effects at 6 months after starting treatment in adult patients with melanoma
Secondary Objectives
Analyze the association between physical activity level and treatment efficacy of immunotherapy in adult melanoma patients
Describe the quarterly evolution of patients39 general condition through measurement of WHO status and BMI
Assess the evolution of patients39 general condition WHO status and BMI at treatment introduction after 3 months and at 6 months of treatment
Study the evolution of patients39 quality of life during their treatment based on their physical activity level using the QLQ-C30 questionnaire
Preliminary study
We aim to evaluate the correlation between self-reported physical activity by patients and their actual physical activity To obtain an objective measurement of patients39 physical activity level we plan to work with the CARTIGEN platform and offer a small number of included patients maximum of 50 to wear wrist actimeters for one week before treatment initiation We will then analyze these data to determine patients39 baseline physical activity levels and compare them with the data collected via questionnaires
This is a prospective cohort study within the context of analytical epidemiological research It is a bicentric study CHRU Montpellier - Saint-Eloi Hospital and ICM Val d39Aurelle
Using the collected data on patients39 physical activity levels IPAQ questionnaire we will compare two groups patients who experienced immuno-toxicities without physical activity versus those with moderate or high physical activity
We will also analyze treatment efficacy in these two groups patients39 quality of life and the evolution of their general condition
Procedure
Inclusion is planned at day 0 D0 with physical activity IPAQ3 and quality of life QLQ-C30 questionnaires along with clinical and oncological evaluation
A follow-up visit at month 3 M3 will include reassessment of clinical and oncological status followed by another visit at month 6 M6 for further clinical oncological physical activity and quality of life reassessment
The inclusion period is expected to last 18 months
Outcomes Perspectives
If we consider that physical exercise may help mitigate the toxic effects of treatments-an aspect we wish to explore through this project-it would be relevant to introduce adapted physical activity APA sessions supervised by a specialized instructor within the Dermatology Day Hospital at the CHU of Montpellier
Implementing APA in the context of onco-dermatology will strengthen the multidisciplinary approach of the CHU
Collaboration between healthcare professionals including specialized APA instructors will foster effective care coordination
This initiative is part of a holistic approach to patient care integrating complementary interventions to address physical psychological and social needs
Immunotherapies are treatments that have revolutionized the prognosis of patients with melanoma These are therapies that work by stimulating the immune system to enhance the anti-tumor response Their toxicities are represented by immune-mediated toxicities similar to true autoimmune diseases
Adapted physical activity as supportive care in oncology is expanding From a pathophysiological perspective physical activity is thought to modulate the immune system by reducing inflammation restoring immune surveillance stimulating anti-tumor responses through the induction of T cell proliferation modulating the gut microbiota and influencing tumor microenvironment cells etc
The modulation of the immune system by physical activity may also allow us to hypothesize a modulation of the toxicities induced by immune checkpoint inhibitors We wish to study this hypothesis in patients with advanced melanoma who are candidates for immunotherapy
Originality and Innovative Aspects
Physical activity as supportive care in oncology has developed significantly in recent years However adapted physical activity APA is currently only offered at one center in France CHU de Lille
In addition to the probable impact on patients39 quality of life if we find evidence supporting a reduction in treatment-related toxicities for melanoma through physical activity it would be even more interesting to introduce APA at the CHU of Montpellier
Primary and Secondary Objectives
Primary Objective To analyze the association between the level of physical activity estimated by the IPAQ questionnaire at the initiation of immunotherapy and the occurrence of adverse effects at 6 months after starting treatment in adult patients with melanoma
Secondary Objectives
Analyze the association between physical activity level and treatment efficacy of immunotherapy in adult melanoma patients
Describe the quarterly evolution of patients39 general condition through measurement of WHO status and BMI
Assess the evolution of patients39 general condition WHO status and BMI at treatment introduction after 3 months and at 6 months of treatment
Study the evolution of patients39 quality of life during their treatment based on their physical activity level using the QLQ-C30 questionnaire
Preliminary study
We aim to evaluate the correlation between self-reported physical activity by patients and their actual physical activity To obtain an objective measurement of patients39 physical activity level we plan to work with the CARTIGEN platform and offer a small number of included patients maximum of 50 to wear wrist actimeters for one week before treatment initiation We will then analyze these data to determine patients39 baseline physical activity levels and compare them with the data collected via questionnaires
This is a prospective cohort study within the context of analytical epidemiological research It is a bicentric study CHRU Montpellier - Saint-Eloi Hospital and ICM Val d39Aurelle
Using the collected data on patients39 physical activity levels IPAQ questionnaire we will compare two groups patients who experienced immuno-toxicities without physical activity versus those with moderate or high physical activity
We will also analyze treatment efficacy in these two groups patients39 quality of life and the evolution of their general condition
Procedure
Inclusion is planned at day 0 D0 with physical activity IPAQ3 and quality of life QLQ-C30 questionnaires along with clinical and oncological evaluation
A follow-up visit at month 3 M3 will include reassessment of clinical and oncological status followed by another visit at month 6 M6 for further clinical oncological physical activity and quality of life reassessment
The inclusion period is expected to last 18 months
Outcomes Perspectives
If we consider that physical exercise may help mitigate the toxic effects of treatments-an aspect we wish to explore through this project-it would be relevant to introduce adapted physical activity APA sessions supervised by a specialized instructor within the Dermatology Day Hospital at the CHU of Montpellier
Implementing APA in the context of onco-dermatology will strengthen the multidisciplinary approach of the CHU
Collaboration between healthcare professionals including specialized APA instructors will foster effective care coordination
This initiative is part of a holistic approach to patient care integrating complementary interventions to address physical psychological and social needs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None