Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298734
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-03-01
Brief Title:
High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients The DUO Trial
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients The DUO Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy
The names of the groups in this research study are
High-Intensity Exercise EX
High-fiber Diet DT
Combined High-Intensity Exercise and High-Fiber Diet COMB
Attention Control AC
The names of the groups in this research study are
High-Intensity Exercise EX
High-fiber Diet DT
Combined High-Intensity Exercise and High-Fiber Diet COMB
Attention Control AC
Detailed Description:
This single-center four-arm pilot randomized research study is to test if high-intensity exercise and high-fiber diet are feasible and effective in improving the gut microbiome health immune function physical fitness treatment-related side effects and treatment outcomes in participants with advanced melanoma receiving immunotherapy Participants will be randomized into 1 of 4 study groups Group A Exercise Group B Diet Group C Combined and Group D Attention Control Randomization means a participant will be placed into an intervention group by chance
The information learned by doing this research may help determine whether participating in such lifestyle interventions are tolerable during immunotherapy and exert health benefits among melanoma participants
The research study procedures include screening for eligibility study visits stool samples blood tests and questionnaires
Participation in this study is expected to last up to a total of 9 weeks
It is expected about 40 people will take part in this research study
This study is sponsored by the World Cancer Research Fund International
The information learned by doing this research may help determine whether participating in such lifestyle interventions are tolerable during immunotherapy and exert health benefits among melanoma participants
The research study procedures include screening for eligibility study visits stool samples blood tests and questionnaires
Participation in this study is expected to last up to a total of 9 weeks
It is expected about 40 people will take part in this research study
This study is sponsored by the World Cancer Research Fund International
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None