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Fatigue | Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy

Fatigue research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Fatigue

Unspecified Adult Solid Tumor, Protocol Specific

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:exercisehome based walking and progressive resistance training exercise

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Standard Care + EXCAPPersonalized exercise prescription

Standard CareWait list control

Study Status

Completed

Start Date: September 2009

Completed Date: October 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Karen M. Mustian, PhD

Lead Sponsor: Gary Morrow

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT00924651

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