Ignite Creation Date:
2024-05-06 @ 12:44 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01642680
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2012-07-04
Brief Title:
Optimal Timing of Physical Activity in Cancer Treatment
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Optimal Timing of a Tailored Physical Activity Program During Chemotherapeutic Cancer Treatment to Reduce Long-term Cardiovascular Morbidity
Status:
COMPLETED
Status Verified Date:
2024-05
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:
ACT
Brief Summary:
The number of long-term cancer survivors is growing As a result treatment-related morbidity - such as cardiovascular disease metabolic syndrome functional decline and fatigue - is impacting quality of life and impairing survival Metabolic syndrome in the general population is currently treated with lifestyle advice to increase physical activity PA and reduce caloric intake This approach is still underused as standard care for cancer survivors The aim of this study is investigate whether a tailored PA program that starts early during curative chemotherapy with cardiovascular toxic potential is superior in terms of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular morbidity to a program that starts late after completion of chemotherapy
Detailed Description:
Improved treatment is partly responsible for the increased survival and life expectancy in cancer patients However such treatment can be harmful as well and cancer survivors therefore face an increased risk of second malignancies and other chronic diseases eg cardiovascular diseases and metabolic syndrome
Due to the growing number of cancer patients and survivors attention for rehabilitation especially physical training is growing Several meta-analyses show the beneficial effects of physical training on several outcomes such as physical fitness muscle strength fatigue and quality of life and a few studies showed the effect of exercise on physical active behaviour However studies on the effect of timing of exercise are lacking
The present study aims to insert a tailored physical activity program early versus late in the chemotherapy based cancer treatment and will yield data about its safety and efficacy We hypothesize that a tailored physical activity program during early cancer treatment may more be effective to reduce long-term cancer treatment toxicities and morbidity in cancer survivors compared to a program after cancer treatment
Primary Objective To investigate whether a tailored physical activity program that starts during chemotherapy early is superior in terms of physical fitness as determined by VO2 peak at one year to a program that starts after completion of chemotherapy late
Secondary Objectives To examine the effect of the physical activity program on muscle strength and activity level change in metabolic and cardiovascular damage parameters cardiovascular risk factors and quality of life including self-efficacy motivation for exercise and fatigue
Design This protocol describes a multicenter randomized study with 2 arms Patients who will be treated with curative systemic chemotherapeutic treatment for testicular cancer early colon cancer early breast cancer or B-NHL will be randomized into an early or late PA program group The early group will start the PA program during chemotherapy for 12 weeks until 12 weeks after completion of chemotherapy total 24 weeks of training The late group will start the same program total of 12 weeks after completion of chemotherapy The longitudinal effects of the physical activity PA program for all participants will be evaluated at different time points in the UMCG before start of chemotherapeutic treatment at the start of the PA program and at 3 6 18 months after starting the PA program and 18 months after the last chemotherapy
Due to the growing number of cancer patients and survivors attention for rehabilitation especially physical training is growing Several meta-analyses show the beneficial effects of physical training on several outcomes such as physical fitness muscle strength fatigue and quality of life and a few studies showed the effect of exercise on physical active behaviour However studies on the effect of timing of exercise are lacking
The present study aims to insert a tailored physical activity program early versus late in the chemotherapy based cancer treatment and will yield data about its safety and efficacy We hypothesize that a tailored physical activity program during early cancer treatment may more be effective to reduce long-term cancer treatment toxicities and morbidity in cancer survivors compared to a program after cancer treatment
Primary Objective To investigate whether a tailored physical activity program that starts during chemotherapy early is superior in terms of physical fitness as determined by VO2 peak at one year to a program that starts after completion of chemotherapy late
Secondary Objectives To examine the effect of the physical activity program on muscle strength and activity level change in metabolic and cardiovascular damage parameters cardiovascular risk factors and quality of life including self-efficacy motivation for exercise and fatigue
Design This protocol describes a multicenter randomized study with 2 arms Patients who will be treated with curative systemic chemotherapeutic treatment for testicular cancer early colon cancer early breast cancer or B-NHL will be randomized into an early or late PA program group The early group will start the PA program during chemotherapy for 12 weeks until 12 weeks after completion of chemotherapy total 24 weeks of training The late group will start the same program total of 12 weeks after completion of chemotherapy The longitudinal effects of the physical activity PA program for all participants will be evaluated at different time points in the UMCG before start of chemotherapeutic treatment at the start of the PA program and at 3 6 18 months after starting the PA program and 18 months after the last chemotherapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 41087 | REGISTRY | ABR | None |