Female Breast CancerYogaRTNCT04775290
Yoga on QOL Physiological Distress&Fatigue, on Patients Affected by Breast Cancer in Adjuvant Radiotherapy
A study testing Yoga lessons in people with Female Breast Cancer and Fatigue, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
The study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on QOL and fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Breast Cancer, Fatigue, Quality of Life
- What is being tested?
- Yoga lessons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 2 Aug 2019to 4 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.
Meldola, Forlì-Cesena, 47014
About this study
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
The study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on QOL and fatigue.
Read the 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.
- Conditions
- Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications
- Being tested
- Yoga lessons
- Keywords
- Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga lessonsBehavioural
2 weekly yoga classes during the 5 weeks of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm Yoga (YG) | Experimental | Patients assigned to the YG arm participate in yoga classes Receives: Behavioral: Yoga lessons |
| Arm control (CG) | No intervention | Patients assigned to the CG arm will follow the normal course of radiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 32 months
Secondary outcomes (1)
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).
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start2 Aug 2019
- Primary completion1 Feb 2020
- Study completion4 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Micheletti, MD, Principal investigator, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775290
- Sponsor's protocol ID
- IRST174.21
- Acronym
- YogaRT
- Status last verified
- Feb 2021
- First submitted
- 14 Dec 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40421669
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04775290
- Acronym / sponsor ID
- YogaRT / IRST174.21
- Conditions
- Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications
- Keywords
- Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 4 Apr 2022 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on QOL and fatigue.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Yoga (YG) | Experimental | Behavioral: Yoga lessonsPatients assigned to the YG arm participate in yoga classes |
| Arm control (CG) | No intervention | –Patients assigned to the CG arm will follow the normal course of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga lessons2 weekly yoga classes during the 5 weeks of radiotherapy | Behavioural | Arm Yoga (YG) |
Primary outcome
Change of physiological distress
Time frame: 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
1 secondary outcome
Evaluation of quality of life with yoga during and after radiotherapy
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Derived from this study: PubMed 40421669Messer 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.
Related trials for Female Breast Cancer
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simona Micheletti, MD principal investigator
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga lessons in people with Female Breast Cancer and Fatigue, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of physiological distress (time frame: up to 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04775290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.