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MR Therapy for Gynecological Condition

N/A
Waitlist Available
Led By Jon Hunter, MD, FRCP
Research Sponsored by M.D. Anderson Cancer Center
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 up to 12 months post treatment
Awards & highlights

Study Summary

This trial is studying how well mindfulness relaxation works compared to relaxing music or standard symptom management education in treating patients with newly diagnosed solid tumors who are receiving chemotherapy.

Eligible Conditions
  • Solid Tumors
  • Gynecological Condition
  • Gastrointestinal Cancer
  • Breast Cancer
  • Nausea and Vomiting
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post 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
Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)
Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)
Depression as measured by Center for Epidemiology-Depression (CES-D)
+5 more
Secondary outcome measures
Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Relaxing Music (RM) TherapyExperimental Treatment2 Interventions
Arm II: Participants listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment.
Group II: MR TherapyExperimental Treatment2 Interventions
Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. A CD with the mindfulness relaxation technique recorded on it will be given to participant. Participant to listen to the recording for about 30 minutes before receiving chemotherapy and during the time they are receiving chemotherapy. In addition to the mindfulness relaxation technique, they will also receive general information about how to manage symptoms that develop due to the chemotherapy they are receiving.
Group III: Standard Symptom ManagementActive Control2 Interventions
Arm III: Participants receive standard symptom management education.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relaxing Music (RM) Therapy
2004
N/A
~480
MR Therapy
2004
N/A
~480
Questionnaires
2013
Completed Phase 2
~3330

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,679 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,307 Total Patients Enrolled
Jon Hunter, MD, FRCPPrincipal InvestigatorMount Sinai Hospital, Canada

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors
2004. "Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00086762.
~23 spots leftby Apr 2025
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