NCT04775290

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

December 14, 2020

Last Update Submit

February 25, 2021

Conditions

Female Breast CancerFatigueQuality of LifePhysiological StressRadiotherapy; Complications

Keywords

Female Breast CancerFatigueQuality of LifePhysiological StressRadiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation of quality of life with yoga during and after radiotherapy

    up to 6 months

Study Arms (2)

Arm Yoga (YG)

EXPERIMENTAL

Patients assigned to the YG arm participate in yoga classes

Behavioral: Yoga lessons

Arm control (CG)

NO INTERVENTION

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

Interventions

Yoga lessonsBEHAVIORAL

2 weekly yoga classes during the 5 weeks of radiotherapy

Arm Yoga (YG)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.

Meldola, Forlì-Cesena, 47014, Italy

Location

Related Publications (1)

  • Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.

    PMID: 40421669DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Simona Micheletti, MD

    IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

March 1, 2021

Study Start

August 2, 2019

Primary Completion

February 1, 2020

Study Completion

April 4, 2022

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

IT(1)