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

Phase 3
30 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

Part of the mission of the Dana-Farber/Brigham and Women's Cancer Center is to enhance the
quality of life for cancer patients and their families. Treatments and therapies
specifically designed to address changes in the cognitive, emotional and spiritual realm
experienced by patients as they attempt to cope with cancer are now routinely offered in
addition to standard and experimental medical therapies and fall into the realm of
complementary and alternative medicine (CAM) and support. Our patients may participate in
support groups; work with a social worker, psychologist or psychiatrist privately; learn
about diet in seminars or meet with a dietician; participate in art or music therapy; or
participate in the many programs offered by the Leonard P. Zakim Center, which include Reiki
therapy, acupuncture, acupressure, massage and therapeutic touch. All of these services are
provided with the hope that the participants derive some benefit, however intangible. That
cancer patients experience significant short- and long-term psychological distress
associated with their cancer diagnosis and treatment is well documented.1-4 Most feel a
strong sense of lost self-control and experience disturbances in appetite, sleep,
concentration, and stamina.5-9 Anxiety and depression appear to be almost ubiquitous with a
cancer diagnosis, including those men diagnosed with prostate cancer.8,10-12 This may
explain the prevalence of prostate cancer support groups, internet sites and self-help
books. However, we have little precise information on our own prostate cancer population
with regards to the choices they make regarding CAM and no information on how CAM therapies
affect them.

There are some data on the use of CAM in other prostate cancer populations.13-16 In a study
of 1,099 men, the prostate cancer diagnosis prompted 23.5% of the sample to start using some
form of CAM for health, and 67% of the group reported having used some form of CAM for
prostate health before being diagnosed.17 The study included 14 herbal or dietary therapies
and 16 mind-body therapies. There were demographic differences between patients who opted
for CAM use and those who did not. Patients choosing CAM were more likely to be white
versus not, and more likely to be college-educated versus not. The latter variable was
particularly significant in this analysis. A second study of patients living in and around
San Francisco reported on 543 prostate cancer patients who completed a 30-minute telephone
interview regarding complementary and alternative medicines.14 Overall, 30% of the
participants used at least one type of complementary or alternative medicine. CAM users
were younger than non-users and likely to be college graduates. In this group, herbal
remedies and mental health approaches were the most commonly utilized, followed by dietary
changes. Twelve percent of the population used two or more CAM approaches.11

For our own study, we chose to look at two forms of CAM, Reiki and relaxation response
therapy (RRT). These two were chosen as we had some evidence of utilization within our own
cancer population. Reiki treatment is given at the Zakim Center. In the four years since the
Zakim Center opened, there have been approximately 300 patient visits for Reiki therapy.
Reiki is an energy healing method discovered in the late 1800s in Japan. The word Reiki is
made up of two Japanese words: Rei, an unlimited universal power of force that acts in all
created matter; and Ki, a living spirit energy that applies to the physical principle of
life. Licensed Reiki Masters perform Reiki. All of the Reiki Masters at the Zakim Center
are also registered nurses. Subjects often express an enhanced sense of well-being and
relaxation after a Reiki session, according to the Reiki practitioners, and most return for
at least one more session. Led by Susan DeCristofaro, the Reiki experience at the Zakim
Center has been standardized. Here, Reiki is given for acute and chronic pain, headache,
depression, anxiety, nausea, vomiting and insomnia. The fee for a Reiki session is $55.00.
However, the effects of receiving Reiki have not been subjected to rigorous scientific
study. In a review of energy healing, eleven studies looking at Reiki were reviewed. Of
these, seven showed a beneficial effect,18-22 three showed no effect21,23,24 and one had a
negative effect.25 We believe, after review of this data, that there are many unanswered
questions about this treatment.

The second CAM of interest to us was relaxation response therapy (RRT), described and
pioneered at the Mind/Body Medical Institute, directed by Herbert Benson, MD. The Mind/Body
Medical Institute is an independent, nonprofit organization dedicated to the study of
mind/body interactions, including RRT. Three to four hundred cancer patients per year
participate in programs at the Mind/Body Medical Institute. Interventions using RRT in
combination with cognitive restructuring (CR) counseling are commonly employed and are felt
to be 'successful' in cancer patients by the practitioners who deliver them.

The term "relaxation response" was first coined in 1974.26,27 This technique has two
characteristics: repetition of a word or phrase and a disregard of everyday thoughts. The
elicitation of the RR down-regulates the sympathetic nervous system. It is characterized by
reductions in oxygen consumption, respiratory rate, blood pressure, heart rate and arterial
blood lactate. The mind/body state achieved with RR is consistent with a wakeful,
hypometabolic physiological state.28 EEG studies clearly differentiate the RR from sleep.29
PET30 and fMRI31 studies have correlated specific regional changes in brain activity with
the elicitation of the RR. When the patient is in a relaxed state, the therapist focuses on
helping him to identify emotions, negative thoughts or anxieties and assisting him to deal
with these thoughts in a more constructive way. This is called "cognitive restructuring" and
it is an integral part of RT.

RRT is believed to be a useful therapeutic intervention in numerous conditions including:
headache;32-34 premature ventricular contractions in stable ischemic heart disease or
hypertension;35-38 anxiety;39,40 stress symptoms;41 cardiac surgery;37 pain relief and
anxiety reduction in femoral arteriography;42 premenstrual syndrome;43 infertility;44
psychosomatic complaints;45 chronic pain;46-48 and insomnia.29 Other investigators have also
found that RRT techniques were effective in the treatment of rheumatoid arthritis. The fee
for RT with cognitive restructuring is $100.00 per hour, paid for privately or through

Thus, we identified two reasonably mature CAM therapies offered and apparently utilized by
our own patients, paid for by the patients and their insurance providers, believed by the
practitioners to be beneficial to patients but without much solid evidence to support their
use. We also know that prostate cancer patients have a high level of interest in CAM. With
this in mind, we applied for and received a grant from the Advanced Medical Research
Foundation and submitted a protocol to the Dana-Farber/ Harvard Cancer Center Internal
Review Board with the primary aim of assessing the feasibility of recruiting and maintaining
enrollment in CAM therapy during an 8-week course of RT and a 2-month follow-up period. Our
protocol was accepted, #05-005, and is now accruing patients.

Inclusion Criteria:

1. Age > 30

2. Histologic documentation of prostate cancer (no time limit)

3. Gleason score assignment is mandatory prior to entry

4. ECOG Performance Status of 0, 1, or 2

5. Clinical Stage Tl - T4 adenocarcinoma of the prostate

6. Planned androgen suppression therapy prior to an eight-week course of external beam

7. Signed Informed Consent

Exclusion Criteria:

1. Prior pelvic radiotherapy

2. Evidence of metastatic disease

3. Currently receiving ongoing psychotherapy or antidepressive medications

4. Non-English speaking

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Obtain preliminary results on the effectiveness of these treatments compared to controls

Outcome Description:

QOL testing performed at four time points

Outcome Time Frame:

Measurements taken at multiple time points

Safety Issue:


Principal Investigator

Clair Beard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2005

Completion Date:

February 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Reiki
  • Relaxation Response
  • Cognitive Restructuring
  • Feasibility
  • Prostatic Neoplasms



Brigham and Women's Hospital Boston, Massachusetts  02115