NCT02056067

Brief Summary

The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months and are experiencing at least mild arthralgia originating during AI treatment, the yearlong effect of exercise vs. attention control (health education), and on toxic side effects of AI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable breast-cancer

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

June 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

February 4, 2014

Last Update Submit

March 4, 2020

Conditions

Breast CancerArthralgia

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Arthralgia Severity

    Measured using the Brief Pain Inventory (BPI). Subjects are asked to rate pain by circling a number from 0-10 that describes pain at its "worst", "least", and "average" with 0 being no pain and 10 being "pain as bad as you can imagine".

    6 months

  • Change from Baseline in Arthralgia Severity

    Measured using the Brief Pain Inventory (BPI). Subjects are asked to rate pain by circling a number from 0-10 that describes pain at its "worst", "least", and "average" with 0 being no pain and 10 being "pain as bad as you can imagine".

    12 months

Study Arms (2)

Exercise

EXPERIMENTAL

The exercise intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include twice weekly strength-training sessions and 150 min of walking/week (e.g., three 50-min walking sessions or five 30-min walking sessions) over 12 months.

Behavioral: Exercise

Attention Control (Health Education)

ACTIVE COMPARATOR

The Attention Control Group will be provided written information that emphasizes the importance of a healthy lifestyle. Participants will be encouraged to follow the NCI and ACS physical activity guidelines. This procedure was followed in our exercise trials, with no increase in physical activity levels observed at follow-up among women in the usual care group. Attention Control participants will also receive frequent contacts throughout the 12 month intervention. Each month, women randomized to attention control will be contacted by phone to discuss a health education topic of interest

Behavioral: Attention Control (Health Education)

Interventions

ExerciseBEHAVIORAL

The exercise intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include twice weekly strength-training sessions and 150 min of walking/week (e.g., three 50-min walking sessions or five 30-min walking sessions) over 12 months.

Exercise
Attention Control (Health Education)BEHAVIORAL

The Attention Control Group will be provided written information that emphasizes the importance of a healthy lifestyle. Participants will be encouraged to follow the NCI and ACS physical activity guidelines. This procedure was followed in our exercise trials, with no increase in physical activity levels observed at follow-up among women in the usual care group. Attention Control participants will also receive frequent contacts throughout the 12 month intervention. Each month, women randomized to attention control will be contacted by phone to discuss a health education topic of interest

Attention Control (Health Education)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women (defined as the surgical or natural absence of menstrual cycles for at least 1 year prior to breast cancer diagnosis).
  • years or younger
  • AJCC Stages I-IIIC Breast Cancer
  • Taking an AI for at least 2 months
  • Currently experiencing at least mild arthralgia (= or \> 3 on the BPI) associated with AI use
  • Physically able to exercise and physician consent to start an exercise program
  • Sedentary activity pattern (\< 90 mins/week of moderate-to-vigorous intensity sports activity) within the past year and low fitness level
  • No more than one strength training session per week within the past year
  • Agrees to be randomly assigned to either exercise or attention control
  • Gives informed consent to participate in all study activities
  • Able to come for baseline, 6-, and 12-month clinic visits and strength training sessions (6-month intervention study - able to come for baseline, 6-month clinic visits and strength training sessions).
  • Mentally competent

You may not qualify if:

  • Lymphedema with self reported 'flare up' in the past 4 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, United States

Location

Related Publications (2)

  • Thomas GA, Cartmel B, Harrigan M, Fiellin M, Capozza S, Zhou Y, Ercolano E, Gross CP, Hershman D, Ligibel J, Schmitz K, Li FY, Sanft T, Irwin ML. The effect of exercise on body composition and bone mineral density in breast cancer survivors taking aromatase inhibitors. Obesity (Silver Spring). 2017 Feb;25(2):346-351. doi: 10.1002/oby.21729. Epub 2016 Dec 27.

    PMID: 28026901DERIVED

  • Irwin ML, Cartmel B, Gross CP, Ercolano E, Li F, Yao X, Fiellin M, Capozza S, Rothbard M, Zhou Y, Harrigan M, Sanft T, Schmitz K, Neogi T, Hershman D, Ligibel J. Randomized exercise trial of aromatase inhibitor-induced arthralgia in breast cancer survivors. J Clin Oncol. 2015 Apr 1;33(10):1104-11. doi: 10.1200/JCO.2014.57.1547. Epub 2014 Dec 1.

    PMID: 25452437DERIVED

MeSH Terms

Conditions

Breast NeoplasmsArthralgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Melinda Irwin, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 5, 2014

Study Start

June 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 5, 2020

Record last verified: 2020-03

Locations

US(1)