Clinical trial · Interventional
Progressive Relaxation Training in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy
Effects of Progressive Relaxation Training on Artralgia, Quality of Life and Emotional Status in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy
NCT04163692CI-TRIAL-00050982PREBCAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study evaluates the effects of progressive relaxation exercises on artralgia, quality of life and anxiety-deppression in breast cancer patients receiving aromatase inhibitor. Half of the participants will receive supervised progressive relaxing exercises, while other half will not receive any exercise but only advice about relaxing. Hypothesis: Progressive relaxation exercises improve the pain, quality of life and emotional status in breast cancer patients receiving aromatase inhibitor therapy.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Progressive relaxation exercises | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise Group
- description
- Progressive relaxation exercises (PRE) as 1 day supervised and 3 days home based program in a week, for 6 weeks
- interventionNames
- Other: Progressive relaxation exercises
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Information was provided about pain and its treatment and the importance of relaxing exercises without any intervention, up to 6 weeks.
Primary outcomes (1)
- measure
- Brief pain inventory (BPI)
- timeFrame
- 24 hours
- description
- Assesses the severity of pain and its impact on functioning. Consisting of 17 questions, evaluating pain location, severity, and pain status, especially in the last 24 hours. Scores of 3-4 are defined as mild, 5-7 as moderate, 8-10 as severe pain in this scale.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Using Aromatase Inhibitors for more than 6 months * Diagnosis of breast cancer stage 1-3 * Postmenopausal woman aged under 70 years and with hormone-receptor positive * Approval of physician for participating in PRE program Exclusion Criteria: * Participation on a regular physical training in the previous 6 months period * Communication problems * Neurological or ortopedical problems * Presence of lyphedema diagnosis
References
Publications (7)
- BACKGROUNDCuzick J, Sestak I, Forbes JF, Dowsett M, Knox J, Cawthorn S, Saunders C, Roche N, Mansel RE, von Minckwitz G, Bonanni B, Palva T, Howell A; IBIS-II investigators. Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial. Lancet. 2014 Mar 22;383(9922):1041-8. doi: 10.1016/S0140-6736(13)62292-8. Epub 2013 Dec 12. PMID 24333009
- BACKGROUNDEarly Breast Cancer Trialists' Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015 Oct 3;386(10001):1341-1352. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23. PMID 26211827
- BACKGROUNDMincey BA, Duh MS, Thomas SK, Moyneur E, Marynchencko M, Boyce SP, Mallett D, Perez EA. Risk of cancer treatment-associated bone loss and fractures among women with breast cancer receiving aromatase inhibitors. Clin Breast Cancer. 2006 Jun;7(2):127-32. doi: 10.3816/CBC.2006.n.021. PMID 16800971
- BACKGROUNDBender CM, Sereika SM, Brufsky AM, Ryan CM, Vogel VG, Rastogi P, Cohen SM, Casillo FE, Berga SL. Memory impairments with adjuvant anastrozole versus tamoxifen in women with early-stage breast cancer. Menopause. 2007 Nov-Dec;14(6):995-8. doi: 10.1097/gme.0b013e318148b28b. PMID 17898668
- BACKGROUNDCella D, Fallowfield L, Barker P, Cuzick J, Locker G, Howell A; ATAC Trialistsa9 Group. Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer. Breast Cancer Res Treat. 2006 Dec;100(3):273-84. doi: 10.1007/s10549-006-9260-6. Epub 2006 Jun 21. PMID 16944295
- BACKGROUNDBreckenridge LM, Bruns GL, Todd BL, Feuerstein M. Cognitive limitations associated with tamoxifen and aromatase inhibitors in employed breast cancer survivors. Psychooncology. 2012 Jan;21(1):43-53. doi: 10.1002/pon.1860. Epub 2010 Oct 21.