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

I

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Status

Unknown

Conditions

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

Treatments

Behavioral: Yoga lessons

Study type

Interventional

Funder types

Other

Identifiers

NCT04775290
IRST174.21

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Arm Yoga (YG)
Experimental group
Description:
Patients assigned to the YG arm participate in yoga classes
Treatment:
Behavioral: Yoga lessons
Arm control (CG)
No Intervention group
Description:
Patients assigned to the CG arm will follow the normal course of radiotherapy.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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