Healthy Exercise for Lymphoma Patients (HELP) (HELP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00111865|
Recruitment Status : Unknown
Verified August 2008 by Lance Armstrong Foundation.
Recruitment status was: Active, not recruiting
First Posted : May 27, 2005
Last Update Posted : August 26, 2008
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Behavioral: Aerobic Exercise Training||Phase 3|
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-Hodgkin's lymphoma (NHL) or Hodgkin's 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 days/week 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 6.0 points. Sixty participants in each group will allow us to detect a 10.0 point difference in between group changes with a power of .80 and a two-tailed a of .05 (standard deviation = 18.0 points).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Controlled Trial of Exercise in Lymphoma Patients|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||August 2008|
|Estimated Study Completion Date :||April 2009|
Aerobic Exercise Training
Behavioral: Aerobic Exercise Training
The exercise group will perform supervised stationary cycle ergometer exercise 3 days/week 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.
|No Intervention: Usual Care|
- Change in QoL between baseline and postintervention. [ Time Frame: 12 weeks ]
- Changes in cardiopulmonary fitness [ Time Frame: 12 weeks ]
- psychosocial outcomes [ Time Frame: 12 weeks ]
- body composition [ Time Frame: 12 weeks ]
- treatment completion rates [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111865
|University of Alberta|
|Edmonton, Alberta, Canada, T6G2H9|
|Principal Investigator:||Kerry S Courneya, Ph.D.||University of Alberta|