Trial Information

Randomized Controlled Trial of Exercise in Lymphoma Patients

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).