Study of Complementary Therapies in Men Receiving Radiation Therapy for Prostate Cancer: A Feasibility Trial

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

Randomized clinical study of two CAM therapies, 1) Reiki and 2) Relaxation Response Therapy with Cognitive Restructuring counseling (RRT with CR), compared to an education-only control arm in patients about to begin an eight-week course of external beam radiotherapy (EBRx) for prostate cancer. Generally, we would like to examine the feasibility of studying Reiki and RRT with CR in patients with prostate cancer, and to obtain preliminary results on the effectiveness of these treatments compared to controls. Specific objectives: 1. Determine the proportion of eligible patients who agree to participate in the study 2. Measure compliance with CAM therapy interventions 3. Measure compliance with physiologic and psychological outcome measurement assessments 4. Assess differences between experimental and control groups on measures on depression, anxiety, quality of life, salivary cortisol levels and an immunomarkers

Key facts

Study ID

NCT00207259

Run by

Brigham and Women's Hospital

People needed

60

Starts

2005-03-01

Expected to finish

2017-06-15

Last updated by the study team

2017-07-13

Who can join

Age: 30 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age > 30
• Histologic documentation of prostate cancer (no time limit)
• Gleason score assignment is mandatory prior to entry
• ECOG Performance Status of 0, 1, or 2
• Clinical Stage Tl - T4 adenocarcinoma of the prostate
• Planned androgen suppression therapy prior to an eight-week course of external beam radiotherapy
• Signed Informed Consent

You may not qualify if…

• Prior pelvic radiotherapy
• Evidence of metastatic disease
• Currently receiving ongoing psychotherapy or antidepressive medications
• Non-English speaking

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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