NCT00924651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
693

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 8, 2017

Completed
Last Updated

August 8, 2017

Status Verified

July 1, 2017

Enrollment Period

6.4 years

First QC Date

June 18, 2009

Results QC Date

February 23, 2017

Last Update Submit

July 5, 2017

Conditions

FatigueUnspecified Adult Solid Tumor, Protocol Specific

Keywords

fatigueunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • 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)

    BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue). The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention).

    41 days: Day 0 (before intervention) Day 41 (post intervention)

Study Arms (2)

Standard Care + EXCAP

EXPERIMENTAL

Personalized exercise prescription

Behavioral: exercise

Standard Care

NO INTERVENTION

Wait list control

Interventions

exerciseBEHAVIORAL

home based walking and progressive resistance training exercise

Also known as: EXCAP
Standard Care + EXCAP

Eligibility Criteria

Age21 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (3)

  • 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.

    PMID: 34191201DERIVED

  • 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.

    PMID: 30937600DERIVED

  • 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.

    PMID: 29243164DERIVED

Related Links

MeSH Terms

Conditions

Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Karen M. Mustian, PhD, MPH, Associate Professor
Organization
University of Rochester Medical Center
Karen_Mustian@urmc.rochester.edu
585-273-1796

Study Officials

  • Karen M. Mustian, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 19, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2016

Study Completion

October 1, 2016

Last Updated

August 8, 2017

Results First Posted

August 8, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)