N/A Completed N=693 Randomized Double-blind Supportive Care

Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy

Fatigue · Unspecified Adult Solid Tumor, Protocol Specific

Source: ClinicalTrials.gov NCT00924651 ↗

Enrolled (actual)

693

Serious AEs

0.8%

Results posted

Aug 2017

Primary outcomePrimary: 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

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.

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

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

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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. Informational only — not medical advice.