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 chemotherapy. Secondary objectives are to determine the effects of AET on changes in cardiopulmonary fitness, body weight, body composition, and treatment completion rates.

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 scheduled to receive 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 length of chemotherapy (< 16 weeks versus > 16 weeks), and randomly assigned to either a during chemotherapy (CT) or a post CT exercise group.

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) 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: Based on an analysis of data over the past 5 years, we estimate that approximately 400 individuals with various lymphomas will be evaluated at the Cross Cancer Institute per year. Of these, approximately 190 per year will be offered chemotherapy and be initially eligible for our study. A further 46 may be excluded based on other eligibility criteria, leaving 144 per year or 12 per month eligible for recruitment. The recruitment rate is difficult to estimate precisely because of the variability in our previous trials but we believe that 40% is feasible based on previous experience. Using this percentage, we can expect to recruit 5 participants per month. Given that 60 participants are required in each group (120 in total), we estimate about 24 months (x 5 per month) to recruit 120 participants.

Recruitment will take place at the initial treatment consultation with the medical or radiation oncologist, which is normally about one week prior to the initiation of therapy. 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. The goal is to complete all baseline assessments prior to the initiation of therapy (i.e., in the one week window prior to therapy initiation) but this may not be possible in all cases. An individual will still be considered eligible for the trial if baseline assessments can be completed within one week of initiating therapy.

Interventions: The during CT group will perform supervised stationary cycle ergometer exercise 3 days/week for 12 weeks or for the length of their chemotherapy treatment (whichever is greater) and be progressed from 15 to 45 minutes and 60% to 80% of their VO2 reserve over the course of the intervention. The post CT will be asked not to begin a structured exercise training program during their chemotherapy and will receive the exercise for 4 weeks following the completion of their treatment.

End Points: The primary end point is change in QoL between baseline and postintervention. QoL will be assessed by the Functional Assessment of Cancer Therapy-Anemia (FACT-An) scale. Secondary end points are changes in cardiopulmonary fitness, body weight, body composition, and treatment completion rates. Cardiopulmonary fitness will be assessed by a graded exercise test using gas exchange analysis. Body weight will be measured using an electronic scale. Body composition will be assessed by body mass index and a DEXA scan. Treatment completion rates will be assessed as the dose density of chemotherapy received divided by the dose density planned.

Sample Size: Sample size calculation is based on the primary end point. A clinically important difference (CID) in the FACT-An is 7.0 points. Sixty participants in each group will allow us to detect a 7.0 point difference in between group changes with a power of .80 and a two-tailed a of .05 (standard deviation = 14.0 points).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Non-hodgkin’s lymphoma (including chronic lymphocytic leukemia) or Hodgkin’s disease
• Approval of the treating oncologist
• Scheduled to receive 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