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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04775290
Other study ID # IRST174.21
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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