Yoga on QOL Physiological Distress&Fatigue, on Patients Affected by Breast Cancer in Adjuvant Radiotherapy

Not Applicable

• Conditions: Fatigue; Female Breast Cancer; Quality of Life; Physiological Stress; Radiotherapy; Complications
• Interventions: Behavioral: Yoga lessons

• Registration Number: NCT04775290
• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.

Study Timeline

• Study Start: 2019-08-02
• Primary Completion: 2020-02-01
• Study First Submitted: 2020-12-14
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01
• Study Completion: 2022-04-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm Yoga (YG)	Yoga lessons	Patients assigned to the YG arm participate in yoga classes

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.; 🇮🇹 Meldola, Forlì-Cesena, Italy