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Therapeutic Massage for Breast Cancer (RTTM301 Trial)

N/A
Waitlist Available
Led By Judith G Myers, PhD
Research Sponsored by Floyd Memorial Hospital and Health Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of treatment (6 weeks), end of study (3 months after end of treatment)
Awards & highlights

RTTM301 Trial Summary

A majority of women with breast cancer receive radiation therapy, and many of them experience the debilitating side effects of fatigue and insomnia. There is a need for an effective treatment that could ameliorate these symptoms and improve quality of life in the radiation therapy population. The primary purpose of the proposed research is to study the impact of massage therapy as a tool for the management of fatigue and insomnia experienced by women diagnosed with breast cancer and receiving radiation therapy. The secondary purpose is to explain, at the biochemical level, the effect of therapeutic massage on the level of fatigue and insomnia in radiation therapy patients. Prior studies have shown an association between fatigue and insomnia in the breast cancer patient following radiation therapy and the presence of inflammation as evidenced by increased proinflammatory cytokine production. The investigators hypothesize that therapeutic massage will ameliorate the symptoms of fatigue and insomnia associated with radiation therapy, and will be associated with a reduction in the plasma levels of interleukin-6 (IL-6),soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). This reduction in proinflammatory biomarkers will be due to the activation of the cholinergic anti-inflammatory pathway via the activation of the vagus nerve.

Eligible Conditions
  • Breast Cancer
  • Fatigue
  • Insomnia

RTTM301 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of treatment (6 weeks), end of study (3 months after end of treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of treatment (6 weeks), end of study (3 months after end of treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, and Insomnia Severity Index scores over time.
Secondary outcome measures
Plasma levels of proinflammatory markers: interleukin-6 (IL-6), soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP).

RTTM301 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Therapeutic MassageExperimental Treatment1 Intervention
Group II: No therapeutic massageActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Massage
2008
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Floyd Memorial Hospital and Health ServicesLead Sponsor
Indiana UniversityOTHER
980 Previous Clinical Trials
983,113 Total Patients Enrolled
15 Trials studying Breast Cancer
3,522 Patients Enrolled for Breast Cancer
Judith G Myers, PhDPrincipal InvestigatorIndiana University Southeast

Frequently Asked Questions

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~3 spots leftby Apr 2025