Clinical trial · Interventional
Study of Complementary Therapies in Men Receiving Radiation Therapy for Prostate Cancer: A Feasibility Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reiki & Relaxation Response Therapy with Cognitive Restructuring | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard weekly treatments with radiation oncologist and nurse. All control patients offered intervention at end of 8-week course of radiotherapy.
- type
- EXPERIMENTAL
- label
- Relaxation Therapy
- description
- Weekly relaxation therapy with PhD psychologist and home cognitive restructering practice
- interventionNames
- Behavioral: Reiki & Relaxation Response Therapy with Cognitive Restructuring
- type
- EXPERIMENTAL
- label
- Reiki
- description
- Weekly Reiki therapy with a Reiki therapist, involves laying of the therapist's hands on the patient to rechannel energy, considered pleasant and calming
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
Show eligibility criteria text
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 radiotherapy 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
References
Publications (0)
Data not yet available