Healthy Exercise for Lymphoma Patients (HELP) (HELP)

August 22, 2008 updated by: Lance Armstrong Foundation

Randomized Controlled Trial of Exercise in Lymphoma Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2H9
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in QoL between baseline and postintervention.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in cardiopulmonary fitness
Time Frame: 12 weeks
12 weeks
psychosocial outcomes
Time Frame: 12 weeks
12 weeks
body composition
Time Frame: 12 weeks
12 weeks
treatment completion rates
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lance Armstrong Foundation

Investigators

  • Principal Investigator: Kerry S Courneya, Ph.D., University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

May 26, 2005

First Submitted That Met QC Criteria

May 26, 2005

First Posted (Estimate)

May 27, 2005

Study Record Updates

Last Update Posted (Estimate)

August 26, 2008

Last Update Submitted That Met QC Criteria

August 22, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04 Courneya

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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