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

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04775290

Collaborator

(none)

120

Enrollment

Location

Arms

32.1

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Female Breast Cancer Fatigue Quality of Life Physiological Stress Radiotherapy; Complications	Behavioral: Yoga lessons	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Aug 2, 2019

Actual Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Apr 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm Yoga (YG) Patients assigned to the YG arm participate in yoga classes	Behavioral: Yoga lessons 2 weekly yoga classes during the 5 weeks of radiotherapy
No Intervention: Arm control (CG) Patients assigned to the CG arm will follow the normal course of radiotherapy.

Arm

Intervention/Treatment

Experimental: Arm Yoga (YG)

Patients assigned to the YG arm participate in yoga classes

Behavioral: Yoga lessons

2 weekly yoga classes during the 5 weeks of radiotherapy

No Intervention: Arm control (CG)

Patients assigned to the CG arm will follow the normal course of radiotherapy.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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