Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816187
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-04-03
Brief Title:
Efficacy and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Concurrent Treatment
Sponsor:
Universidad Complutense de Madrid
Organization:
Universidad Complutense de Madrid
Study Overview
Official Title:
Study of the Effectiveness and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Simultaneous Chemotherapy Radiotherapy or Hormonal Treatment
Status:
RECRUITING
Status Verified Date:
2024-03
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:
OBJECTIVE To evaluate the effectiveness of a PET scan in oncological patients with and without simultaneous treatment with chemotherapy radiotherapy or hormonal therapy in improving quality of life and the need for supervision by health professionals during its performance after 6 weeks of intervention DESIGN Randomized controlled clinical trial parallel groups with active control group With randomization blinding patient assessment and data analysis STUDY SUBJECTS 78 patients diagnosed with breast and colon cancer and treated up to 2 years later both with surgery chemotherapy and hormonal treatments aromatase inhibitors tamoxifen INTERVENTION three treatment groups supervised therapeutic exercise group without supervised therapeutic exercise group without chemotherapy radiotherapy or hormonal treatment supervised therapeutic exercise group with simultaneous chemotherapy radiotherapy or hormonal treatment and control group Two groups will be supervised in performing PET for a period of 6 weeks and the other group will do it autonomously and unsupervised Patients will be followed for 1 year with five blinded assessments at baseline after 6 weeks of intervention 3 6 and 12 months after baseline MEASUREMENTS Main Quality of life assessed with questionnaire measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 EORTC QLQ-30 Measured pre-post intervention 3 6 and 12 months Secondary Cancer-related fatigue assessed with the Functional Assessment of scale Chronic Illness Therapy - Fatigue FACIT-F Measured pre-post intervention 3 6 and 12 months Functional capacity measured with the 6-minute walk test Pre-post intervention measurement 3 6 and 12 months Strength assessment measured with manual hydraulic dynamometer and 5 repetitions of the sit-to-stand test Pre-post intervention measurement 3 6 and 12 months
Detailed Description:
OBJECTIVE To evaluate the effectiveness of a PET scan in oncological patients with and without simultaneous treatment with chemotherapy radiotherapy or hormonal therapy in improving quality of life and the need for supervision by health professionals during its performance after 6 weeks of intervention DESIGN Randomized controlled clinical trial parallel groups with active control group With randomization blinding patient assessment and data analysis STUDY SUBJECTS 78 patients diagnosed with breast and colon cancer and treated up to 2 years later both with surgery chemotherapy and hormonal treatments aromatase inhibitors tamoxifen INTERVENTION three treatment groups supervised therapeutic exercise group without supervised therapeutic exercise group without chemotherapy radiotherapy or hormonal treatment supervised therapeutic exercise group with simultaneous chemotherapy radiotherapy or hormonal treatment and control group Two groups will be supervised in performing PET for a period of 6 weeks and the other group will do it autonomously and unsupervised Patients will be followed for 1 year with five blinded assessments at baseline after 6 weeks of intervention 3 6 and 12 months after baseline MEASUREMENTS Main Quality of life assessed with questionnaire measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 EORTC QLQ-30 Measured pre-post intervention 3 6 and 12 months Secondary Cancer-related fatigue assessed with the Functional Assessment of scale Chronic Illness Therapy - Fatigue FACIT-F Measured pre-post intervention 3 6 and 12 months Functional capacity measured with the 6-minute walk test Pre-post intervention measurement 3 6 and 12 months Strength assessment measured with manual hydraulic dynamometer and 5 repetitions of the sit-to-stand test Pre-post intervention measurement 3 6 and 12 monthsCOST
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