Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111865
Status:
UNKNOWN
Last Update Posted:
2008-08-26
First Post:
2005-05-26
Brief Title:
Healthy Exercise for Lymphoma Patients HELP
Sponsor:
Lance Armstrong Foundation
Organization:
Lance Armstrong Foundation
Study Overview
Official Title:
Randomized Controlled Trial of Exercise in Lymphoma Patients
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
HELP
Brief Summary:
Objectives The primary objective of this trial is to determine the effect of aerobic exercise training AET on change in quality of life QoL in lymphoma survivors receiving and not receiving chemotherapy Secondary objectives are to determine the effects of AET on changes in psychosocial outcomes cardiopulmonary fitness body composition and treatment completion rates
Detailed Description:
Design and Setting The study is a randomized controlled trial It will be conducted at the University of Alberta and Cross Cancer Institute in Edmonton Alberta Canada
Participants Participants will be 120 lymphoma survivors diagnosed with either non-Hodgkins lymphoma NHL or Hodgkins disease HD and receiving or not receiving at least 8 weeks of chemotherapy at the Cross Cancer Institute in Edmonton Alberta Participants will be stratified by disease type indolent NHL versus aggressive NHL versus HD and planned chemotherapy protocol no chemotherapy versus 16 weeks versus 16 weeks and randomly assigned to either a 12 week exercise program or usual care
Eligibility Participants will be recruited from the Cross Cancer Institute The eligibility criteria include medical demographic and logistic criterion and are focused on internal validity as well as external validity Eligibility criteria for the study are 1 histologically confirmed lymphoma cancer 2 18 years of age or older 3 not receiving chemotherapy or scheduled to receive at least 2 cycles 8 weeks of chemotherapy excluding high dose chemotherapy with stem cell transplant 4 approval of the treating oncologist 5 able to understand and provide written informed consent in English 6 no uncontrolled hypertension 7 no uncontrolled cardiac illness 8 no active psychiatric condition and 9 no contraindications to exercise as determined by a maximal fitness test conducted by a certified fitness consultant CFC
Recruitment We have recruited 122 participants to the trial The study is now closed to accrual
Recruitment will take place at the treatment or follow-up consultation with the medical or radiation oncologist Interested survivors will receive an information package from the oncologist and a follow-up telephone call from the project director who will explain the study further and answer any questions All individuals who are interested in participating in the study will a be asked to provide informed consent b complete a self administered questionnaire and c be scheduled for a maximal physical fitness test a dual-x-ray absorptiometry DEXA scan and a blood draw The physical fitness test will determine final eligibility for the study
Interventions The exercise group will perform supervised stationary cycle ergometer exercise 3 daysweek for 12 weeks and be progressed from 15 to 45 minutes and 60 to 80 of their VO2 reserve over the course of the intervention The usual care group will be asked not to begin a structured exercise training program during the next 12 weeks and will receive the exercise for 4 weeks following the postintervention assessment
End Points The primary end point is change in the Trial Outcome Index of QoL between baseline and postintervention QoL will be assessed by the Functional Assessment of Cancer Therapy-Anemia FACT-An scale Trial Outcome Index Physical Well-being Functional Well-being and Anemia Subscales Secondary end points are changes in psychosocial outcomes cardiopulmonary fitness body composition and treatment completion rates Cardiopulmonary fitness will be assessed by a graded exercise test using gas exchange analysis Body composition will be assessed by body mass index and a DEXA scan Treatment completion rates will be assessed as the number of chemotherapy cycles received divided by the number planned
Sample Size Sample size calculation is based on the primary end point A clinically important difference CID in the TOI of the FACT-An is 60 points Sixty participants in each group will allow us to detect a 100 point difference in between group changes with a power of 80 and a two-tailed a of 05 standard deviation 180 points
Participants Participants will be 120 lymphoma survivors diagnosed with either non-Hodgkins lymphoma NHL or Hodgkins disease HD and receiving or not receiving at least 8 weeks of chemotherapy at the Cross Cancer Institute in Edmonton Alberta Participants will be stratified by disease type indolent NHL versus aggressive NHL versus HD and planned chemotherapy protocol no chemotherapy versus 16 weeks versus 16 weeks and randomly assigned to either a 12 week exercise program or usual care
Eligibility Participants will be recruited from the Cross Cancer Institute The eligibility criteria include medical demographic and logistic criterion and are focused on internal validity as well as external validity Eligibility criteria for the study are 1 histologically confirmed lymphoma cancer 2 18 years of age or older 3 not receiving chemotherapy or scheduled to receive at least 2 cycles 8 weeks of chemotherapy excluding high dose chemotherapy with stem cell transplant 4 approval of the treating oncologist 5 able to understand and provide written informed consent in English 6 no uncontrolled hypertension 7 no uncontrolled cardiac illness 8 no active psychiatric condition and 9 no contraindications to exercise as determined by a maximal fitness test conducted by a certified fitness consultant CFC
Recruitment We have recruited 122 participants to the trial The study is now closed to accrual
Recruitment will take place at the treatment or follow-up consultation with the medical or radiation oncologist Interested survivors will receive an information package from the oncologist and a follow-up telephone call from the project director who will explain the study further and answer any questions All individuals who are interested in participating in the study will a be asked to provide informed consent b complete a self administered questionnaire and c be scheduled for a maximal physical fitness test a dual-x-ray absorptiometry DEXA scan and a blood draw The physical fitness test will determine final eligibility for the study
Interventions The exercise group will perform supervised stationary cycle ergometer exercise 3 daysweek for 12 weeks and be progressed from 15 to 45 minutes and 60 to 80 of their VO2 reserve over the course of the intervention The usual care group will be asked not to begin a structured exercise training program during the next 12 weeks and will receive the exercise for 4 weeks following the postintervention assessment
End Points The primary end point is change in the Trial Outcome Index of QoL between baseline and postintervention QoL will be assessed by the Functional Assessment of Cancer Therapy-Anemia FACT-An scale Trial Outcome Index Physical Well-being Functional Well-being and Anemia Subscales Secondary end points are changes in psychosocial outcomes cardiopulmonary fitness body composition and treatment completion rates Cardiopulmonary fitness will be assessed by a graded exercise test using gas exchange analysis Body composition will be assessed by body mass index and a DEXA scan Treatment completion rates will be assessed as the number of chemotherapy cycles received divided by the number planned
Sample Size Sample size calculation is based on the primary end point A clinically important difference CID in the TOI of the FACT-An is 60 points Sixty participants in each group will allow us to detect a 100 point difference in between group changes with a power of 80 and a two-tailed a of 05 standard deviation 180 points
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