Fatigue, Female Breast Cancer, Physiological Stress, Quality of Life, Radiotherapy; Complications
Conditions
Keywords
Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications
Brief summary
The study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on QOL and fatigue.
Detailed description
The study aims to assess QoL, fatigue and physiological distress (cortisol and proinflammatory markers) with blood sampling on day 1,15 and last of radiotherapy, at 1-3-6 months after the end of radiotherapy. Patients with breast cancer who will undergo radiotherapy will be randomly assigned to the yoga group (YG) or the control group (CG). Patients in the YG will participate in 2 weekly yoga classes during the 5 weeks of radiation therapy. The classes will be coordinated with the treatment program and will be held in the vicinity of the radiation therapy center.
Interventions
BEHAVIORALYoga lessons
2 weekly yoga classes during the 5 weeks of radiotherapy
Sponsors
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with stage 0-III breast cancer who have undergone adjuvant daily radiotherapy for 5 weeks in Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) Department of Radiation Oncology of Meldola.
Exclusion criteria
* Patients with documented diagnosis of mental disorders (eg Schizophrenia) * Patients with stage IV disease * Patients with active or non-canalised deep vein thrombosis * Patients not undergoing surgery for the basic oncological disease * Patients with mobility problems (eg unable to get up from the chair) * Patients who have practiced yoga or are practicing yoga in the 6 months before the cancer diagnosis. * Patients diagnosed with lymphedema
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of physiological distress | up to 32 months | Evaluation of the efficacy of yoga on reduction of physiological distress after the end of radiotherapy, measured via Short Form 36 (SF-36), Pittsburgh Sleep Quality Index (PSQI) and Quality of life questionnaire Core30 (QLQ-C30) questionnaire, and physiological functions (cortisol, blood sampling with proinflammatory markers evaluation) in stage 0-III breast cancer patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of quality of life with yoga during and after radiotherapy | up to 6 months | Assess whether yoga helps on increase Quality of Life (QOL) and decreasing fatigue via questionnaire Brief Fatigue Inventory (BFI). |
Countries
Italy
Outcome results
None listed