Clinical trial NCT00924651: Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
Official title: A Study of the Effects of Exercise on Cancer-Related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: fatigue
unspecified adult solid tumor, protocol specific
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-06-19
Enrollment: 693
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Physical activity may help lessen fatigue caused by cancer in patients receiving chemotherapy. It is not yet known whether a home-based walking and resistance-band exercise program is effective in lessening fatigue.

PURPOSE: This randomized phase III trial is studying how well exercise works in lessening fatigue caused by cancer in patients undergoing chemotherapy.

Detailed description: OBJECTIVES:

Primary

* Determine the efficacy of a home-based walking and progressive-resistance exercise program in reducing cancer-related fatigue (CRF) in patients undergoing chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to participating site, chemotherapy course length (2 weeks vs 3 weeks), gender, and degree of fatigue reported on the study assessment questionnaire (≤ 5 vs \> 5). Patients are randomized to 1 of 2 intervention arms.

* Arm I: Patients receive standard chemotherapy.
* Arm II: Patients receive a home-based walking kit comprising an Exercise for Cancer Patients Manual, a pedometer, and therapeutic resistance bands. Patients undergo moderately intense aerobic exercise (walking) monitored by a pedometer, and low to moderately intense progressive-resistance exercise using therapeutic resistance bands for 6 weeks. Patients also receive standard chemotherapy.

Patients in both arms undergo assessment of their aerobic capacity and strength by the 6-minute walk test and handgrip dynamometry at baseline and at day 41. They also have a fasting blood draw and wear an actigraph for one week at baseline and week 6. Patients complete Functional Assessment of Chronic Illness Therapy-Fatigue and -Cognitive Subscales, Brief Fatigue Inventory, Multidimensional Fatigue Symptom Inventory, Center for Epidemiological Studies-Depression Scale State Trait Anxiety Inventory, Pittsburgh Sleep Quality Inventory, Profile of Mood States, Aerobic Center Longitudinal Study Physical Activity, and Symptom Inventory questionnaires at baseline and at day 41 and keep a daily exercise diary during study intervention.

Eligibility criteria: Inclusion criteria:

* primary diagnosis of cancer other than leukemia, with no distant metastasis
* chemotherapy naïve
* starting chemotherapy treatments for cancer and scheduled for at least 6 weeks of treatments with treatment cycles of either 2, 3 or 4 weeks. Oral chemotherapy (e.g., Xeloda) is acceptable
* Karnofsky Performance level of 70 or greater
* able to read English

Exclusion criteria:

* diagnosis of leukemia
* metastatic disease
* receiving concurrent radiation therapy
* physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance program
* identified as in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form

Primary outcomes:
measure: Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention)
timeFrame: 41 days: Day 0 (before intervention) Day 41 (post intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Karen M. Mustian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kleckner IR, Jusko TA, Culakova E, Chung K, Kleckner AS, Asare M, Inglis JE, Loh KP, Peppone LJ, Miller J, Melnik M, Kasbari S, Ossip D, Mustian KM. Longitudinal study of inflammatory, behavioral, clinical, and psychosocial risk factors for chemotherapy-induced peripheral neuropathy. Breast Cancer Res Treat. 2021 Sep;189(2):521-532. doi: 10.1007/s10549-021-06304-6. Epub 2021 Jun 30.
citation: Kleckner IR, Kamen C, Cole C, Fung C, Heckler CE, Guido JJ, Culakova E, Onitilo AA, Conlin A, Kuebler JP, Mohile S, Janelsins M, Mustian KM. Effects of exercise on inflammation in patients receiving chemotherapy: a nationwide NCORP randomized clinical trial. Support Care Cancer. 2019 Dec;27(12):4615-4625. doi: 10.1007/s00520-019-04772-7. Epub 2019 Apr 2.
citation: Kleckner IR, Kamen C, Gewandter JS, Mohile NA, Heckler CE, Culakova E, Fung C, Janelsins MC, Asare M, Lin PJ, Reddy PS, Giguere J, Berenberg J, Kesler SR, Mustian KM. Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial. Support Care Cancer. 2018 Apr;26(4):1019-1028. doi: 10.1007/s00520-017-4013-0. Epub 2017 Dec 14.