N/A
N=693
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
Fatigue · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT00924651 ↗Enrolled (actual)
693
Serious AEs
0.8%
Results posted
Aug 2017
Primary outcome: Primary: 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) — 0.9; 0.7 units on a scale — p=0.9148
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- exercise (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Gary Morrow
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
0.9; 0.7 | 0.9148 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00924651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.