NCT01130714

Brief Summary

The purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration 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

Study Start

First participant enrolled

January 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

January 6, 2010

Last Update Submit

August 19, 2015

Conditions

InflammationLung Cancer

Keywords

inflammationchemotherapylung cancer

Outcome Measures

Primary Outcomes (1)

  • Systemic inflammation measured by c-reactive protein.

    12 weeks

Secondary Outcomes (1)

  • Chemotherapy completion

    12 weeks

Study Arms (2)

Resistance training

EXPERIMENTAL

Group assigned to complete resistance training during duration of chemotherapy.

Behavioral: Exercise

Control

NO INTERVENTION

Usual care.

Interventions

ExerciseBEHAVIORAL

Resistance training with resistance bands.

Resistance training

Eligibility Criteria

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

You may qualify if:

  • Histologically diagnosed with lung cancer
  • Stage I, II, or III
  • Eligible for chemotherapy with curative intent
  • years of age or older
  • Approval to participate in study by treating oncologist or family physician

You may not qualify if:

  • Unstable cardiac disease
  • Untreated bone or brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leo Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Location

Related Publications (1)

  • Karvinen KH, Esposito D, Raedeke TD, Vick J, Walker PR. Effect of an exercise training intervention with resistance bands on blood cell counts during chemotherapy for lung cancer: a pilot randomized controlled trial. Springerplus. 2014 Jan 8;3:15. doi: 10.1186/2193-1801-3-15. eCollection 2014.

    PMID: 24683529DERIVED

MeSH Terms

Conditions

InflammationLung Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kristina H Karvinen, PhD

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 6, 2010

First Posted

May 26, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

US(1)