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

Quality of Life Clinical Trial

— YogaRT  

Official title:

Monocentric, Randomized Clinical Trial About the Effect of Yoga Practice on QOL, Physiological Distress and Fatigue, on Patients Affected by Breast Cancer Undergoing Adjuvant Radiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04775290
• Other study ID #: IRST174.21
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: April 4, 2022

Study information

• Verified date: February 2021
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on QOL and fatigue.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: April 4, 2022
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Fatigue
• Female Breast Cancer
• Physiological Stress
• Quality of Life
• Radiotherapy; Complications

Intervention

Behavioral:
• Yoga lessons
2 weekly yoga classes during the 5 weeks of radiotherapy

Locations

Country	Name	City	State
Italy	IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.	Meldola	Forlì-Cesena

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of physiological distress	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	up to 32 months
Secondary	Evaluation of quality of life with yoga during and after radiotherapy	Assess whether yoga helps on increase Quality of Life (QOL) and decreasing fatigue via questionnaire Brief Fatigue Inventory (BFI).	up to 6 months