The Effect of an Exercise Program in Breast Cancer Patients With Joint Pain While Taking Aromatase Inhibitors.

NCT02057536 | Completed

• 1 other identifier: CCC# 34006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if patients taking aromatase inhibitors (AI), who are experiencing joint discomfort and stiffness, would have reduction in this discomfort and stiffness by participating in a directed exercise program. The overarching objective is to improve patient compliance with the medication and ultimately clinical outcome. In this pilot study, we will utilize a scientific approach for proof of concept employing both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and subjective (patient perception) methods to support an evidence based clinical plan. Patients will be divided into two cohorts. Group A will receive AI therapy with a directed exercise program. Group B will receive AI therapy without a directed exercise program. Data will be collected when both cohorts of patients enroll in the study, at the end of PT for Group A and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression scale, and pain level scale.

Conditions

Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness

Keywords

estrogen receptor positive, aromatase inhibitors, exercise,

Outcome Measures

Primary Outcomes (1)

• Pain Disability Index

  directed exercise program will improve patient response to the pain disability index survey.

  8 weeks

Secondary Outcomes (1)

• Plasma levels of inflammatory markers.

  8 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

8 week directed exercise program

Other: Arm A Directed exercise program

Arm B

ACTIVE COMPARATOR

No directed exercise other than patients normal level of activity

Other: Observation

Interventions

Arm A Directed exercise program OTHER

Arm A

Observation OTHER

Arm B

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Women over age 40 with histological evidence of hormone receptor positive breast cancer.
• \. Post- menopausal 3. Adjuvant AI therapy. 4. Significant joint discomfort/stiffness when attempting activities of daily living which began or significantly increased after initiation of AI therapy.
• \. Currently not in an active directed exercise program (\>60 minutes 2x/wk)

You may not qualify if:

• \. Preexisting RA or fibromyalgia. 2. Systemic metastasis 3. ECOG performance status of greater than 2.

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care/Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Observation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

US (1)