Healthy Exercise for Lymphoma Patients (HELP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Lance Armstrong Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Lance Armstrong Foundation
ClinicalTrials.gov Identifier:
NCT00111865
First received: May 26, 2005
Last updated: August 22, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Lymphoma
Behavioral: Aerobic Exercise Training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Exercise in Lymphoma Patients

Resource links provided by NLM:


Further study details as provided by Lance Armstrong Foundation:

Primary Outcome Measures:
  • Change in QoL between baseline and postintervention. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in cardiopulmonary fitness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • psychosocial outcomes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • treatment completion rates [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: April 2005
Estimated Study Completion Date: April 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
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

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-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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-hodgkin's lymphoma (including chronic lymphocytic leukemia) or Hodgkin's disease
  • Approval of the treating oncologist
  • Scheduled to receive no chemotherapy or chemotherapy for at least 8 weeks
  • Able to understand and provide written informed consent in English
  • 18+ years of age
  • No uncontrolled hypertension, cardiac illness, psychiatric condition
  • No contraindication to exercise as determined by a fitness test

Exclusion Criteria:

  • Pregnant.
  • Transplant candidate.
  • Unwilling to accept randomization.
  • Any medical condition that would be a contraindication to exercise. The clinicians will make this decision.
  • Unwilling to travel to/participate in the exercise program as defined by the protocol.
  • Planned/known absence of greater than 2 weeks during the intended study period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111865

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G2H9
Sponsors and Collaborators
Lance Armstrong Foundation
Investigators
Principal Investigator: Kerry S Courneya, Ph.D. University of Alberta
  More Information

Additional Information:
No publications provided by Lance Armstrong Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kerry S. Courneya, University of Alberta
ClinicalTrials.gov Identifier: NCT00111865     History of Changes
Other Study ID Numbers: 04 Courneya
Study First Received: May 26, 2005
Last Updated: August 22, 2008
Health Authority: Canada: Health Canada

Keywords provided by Lance Armstrong Foundation:
physical exercise
quality of life
lymphoma

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014