Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207259
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2005-09-13
Brief Title:
Study of Complementary Therapies in Men Receiving Radiation Therapy for Prostate Cancer A Feasibility Trial
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Study of Complementary Therapies in Men Receiving Radiation Therapy for Prostate Cancer A Feasibility Trial
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Part of the mission of the Dana-FarberBrigham and Womens 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 documented1-4 Most feel a strong sense of lost self-control and experience disturbances in appetite sleep concentration and stamina5-9 Anxiety and depression appear to be almost ubiquitous with a cancer diagnosis including those men diagnosed with prostate cancer810-12 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 populations13-16 In a study of 1099 men the prostate cancer diagnosis prompted 235 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 diagnosed17 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 medicines14 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 approaches11
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 5500 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 effect18-22 three showed no effect212324 and one had a negative effect25 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 MindBody Medical Institute directed by Herbert Benson MD The MindBody Medical Institute is an independent nonprofit organization dedicated to the study of mindbody interactions including RRT Three to four hundred cancer patients per year participate in programs at the MindBody 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 19742627 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 mindbody state achieved with RR is consistent with a wakeful hypometabolic physiological state28 EEG studies clearly differentiate the RR from sleep29 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 headache32-34 premature ventricular contractions in stable ischemic heart disease or hypertension35-38 anxiety3940 stress symptoms41 cardiac surgery37 pain relief and anxiety reduction in femoral arteriography42 premenstrual syndrome43 infertility44 psychosomatic complaints45 chronic pain46-48 and insomnia29 Other investigators have also found that RRT techniques were effective in the treatment of rheumatoid arthritis The fee for RT with cognitive restructuring is 10000 per hour paid for privately or through insurance
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
There are some data on the use of CAM in other prostate cancer populations13-16 In a study of 1099 men the prostate cancer diagnosis prompted 235 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 diagnosed17 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 medicines14 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 approaches11
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 5500 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 effect18-22 three showed no effect212324 and one had a negative effect25 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 MindBody Medical Institute directed by Herbert Benson MD The MindBody Medical Institute is an independent nonprofit organization dedicated to the study of mindbody interactions including RRT Three to four hundred cancer patients per year participate in programs at the MindBody 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 19742627 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 mindbody state achieved with RR is consistent with a wakeful hypometabolic physiological state28 EEG studies clearly differentiate the RR from sleep29 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 headache32-34 premature ventricular contractions in stable ischemic heart disease or hypertension35-38 anxiety3940 stress symptoms41 cardiac surgery37 pain relief and anxiety reduction in femoral arteriography42 premenstrual syndrome43 infertility44 psychosomatic complaints45 chronic pain46-48 and insomnia29 Other investigators have also found that RRT techniques were effective in the treatment of rheumatoid arthritis The fee for RT with cognitive restructuring is 10000 per hour paid for privately or through insurance
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None