FatigueCarfiNCT04433793
Yoga Intervention for Reducing Fatigue in Cancer Patients
A study testing Yoga therapy in people with Fatigue and Cancer, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
Cancer patients suffer from severe exhaustion and tiredness that is disproportionate to previous efforts and that cannot be completely reduced by sleep. The effectiveness of an 8 week yoga therapy (one hour a week) in patients with different cancer types on self-reported fatigue will be tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Yoga therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteGermany
- Study dates
- 12 Oct 2018to 1 Oct 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- oncological disease
- planned to undergo cancer related treatment at radiotherapy outpatient clinic or the interdisciplinary oncological therapy outpatient clinic
- reported fatigue symptoms: (intensity ≥4, impairment ≥ 5).
Who cannot join
- insufficient knowledge of German
- severe emotional or physical impairment
- more than 50km distance to the university hospital which would require travelling.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Würzburg, Interdisciplinary Centre, Palliativ Medicine
Würzburg, Bavaria, 97080
About this study
Official title: Yoga Intervention and Reminder E-mails for Reducing Cancer-related Fatigue - a Study Protocol of a Randomized Controlled Trial
Cancer patients suffer from severe exhaustion and tiredness that is disproportionate to previous efforts and that cannot be completely reduced by sleep. The effectiveness of an 8 week yoga therapy (one hour a week) in patients with different cancer types on self-reported fatigue will be tested.
Read the detailed description
Almost 90% of cancer patients suffer from symptoms of fatigue during treatment. Supporting treatments are increasingly used to alleviate the burden of fatigue. This study examines the short-term effects of yoga on fatigue, depression and quality of life. The aim of this study will evaluate the efficacy of yoga for cancer patients with mixed diagnoses reporting fatigue. We will randomly allocate 124 patients to an intervention group (N=62) receiving yoga and a wait-list control group (N=62) receiving yoga 9 weeks later. The yoga therapy will be performed in weekly sessions of 60 minutes each for 8 weeks. The primary outcome will be self-reported fatigue symptoms. Secondary outcome will be depression and Quality of life
- Being tested
- Yoga therapy
- Keywords
- Yoga, Mindfulness based Intervention, Fatigue, Cancer Patients
- Medical subject headings
- Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga therapyBehavioural
One yoga session will last one hour. It consists of physical exercises (asanas), conscious breathing (Pranayama) and deep relaxation (Savasana). The subsequent body exercises are structured from lying to sitting to standing. The following sequence of exercises will be repeated in each yoga unit: 1) Relaxation: conscious breathing, body scan, mindfulness 2) Vein pump 3) Pelvis and back rotation (adapted variation of the "nakrasana") 4) Pelvis opening (adapted variation of the "supta baddha konasana") 5) Shoulder bridge ("setu bandha sarvangasana) 6) Forward folds (Paschimottanasana and variations with Pranayama) 7) Backbend: intense east stretch (Purvottasana) 8) Diagonal static yoga cat (Majariasana 1 and resting pose) 9) Standing exercise 10) Upward Salute(Urdhva Hastasana) 11) Warrior 1 (Virabhadrasana 1) 12) Warrior 3 (Virabhadrasana 3) 13) Tree (Vrkasana variation) 14) Relaxation (Savasana).
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | Patients in the yoga group will receive yoga therapy, one hour every week for eight weeks. Receives: Behavioral: Yoga therapy |
| Waitlist-control group | No intervention | Patients in the waitlist-control group will receive no intervention at first, but nine weeks after IG, they will get the opportunity to also receive yoga therapy for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from self-reported fatigue after participation in yoga therapy.
Self-reported cancer related fatigue; measured with: European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire - Fatigue 13 (EORTC-QLQ-FA13); Scale 1-4; Higher scores mean a higher burden of fatigue
Measured: T0: At the beginning of the study, T1: after 9 weeks
Secondary outcomes (2)
Changes from Quality of life in cancer patients
self-reported Quality of life in cancer patients, measured with European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire -Cancer 15 Palliativ (EORTC-QLQ-C15-Pal); Item 1- 14: Scale 1-4; Higher scores represent lower quality of life, Item 15: Scale 1-7; a higher value represents higher Overall Quality of life
Measured: T0: At the beginning of the study, T1: after 9 weeks
Changes from Depression
self reported Depression, measured with patient health questionnaire -9 (PHQ-9); Scale: 1-4; higher score represents higher burden of depression
Measured: T0: At the beginning of the study, T1: after 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start12 Oct 2018
- Primary completion16 Mar 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies 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
- Model description
- A randomized controlled trial with cancer patients suffering from fatigue is planned. The study investigates the efficacy in terms of fatigue, depression and quality of life of eight-week yoga therapy (intervention group) compared to an 8-week waiting period without supportive intervention (control group).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Aid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433793
- Sponsor's protocol ID
- DRKS00016034
- Acronym
- Carfi
- Status last verified
- Oct 2020
- First submitted
- 9 Jun 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data that underlie results in publication (demographics and clinical characteristics, fatigue, Depression and Quality of life)
Publications
Zetzl T, Schuler M, Renner A, Jentschke E, van Oorschot B. Yoga intervention and reminder e-mails for reducing cancer-related fatigue - a study protocol of a randomized controlled trial. BMC Psychol. 2019 Sep 18;7(1):64. doi: 10.1186/s40359-019-0339-3.
PubMed 31533823Messer 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Intervention and Reminder E-mails for Reducing Cancer-related Fatigue - a Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04433793
- Acronym / sponsor ID
- Carfi / DRKS00016034
- Keywords
- Yoga, Mindfulness based Intervention, Fatigue, Cancer Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- German Cancer Aid
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 16 Jun 2020 (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.
Cancer patients suffer from severe exhaustion and tiredness that is disproportionate to previous efforts and that cannot be completely reduced by sleep. The effectiveness of an 8 week yoga therapy (one hour a week) in patients with different cancer types on self-reported fatigue will be tested.
Detailed description
Almost 90% of cancer patients suffer from symptoms of fatigue during treatment. Supporting treatments are increasingly used to alleviate the burden of fatigue. This study examines the short-term effects of yoga on fatigue, depression and quality of life. The aim of this study will evaluate the efficacy of yoga for cancer patients with mixed diagnoses reporting fatigue. We will randomly allocate 124 patients to an intervention group (N=62) receiving yoga and a wait-list control group (N=62) receiving yoga 9 weeks later. The yoga therapy will be performed in weekly sessions of 60 minutes each for 8 weeks. The primary outcome will be self-reported fatigue symptoms. Secondary outcome will be depression and Quality of life
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- A randomized controlled trial with cancer patients suffering from fatigue is planned. The study investigates the efficacy in terms of fatigue, depression and quality of life of eight-week yoga therapy (intervention group) compared to an 8-week waiting period without supportive intervention (control group).
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Behavioral: Yoga therapyPatients in the yoga group will receive yoga therapy, one hour every week for eight weeks. |
| Waitlist-control group | No intervention | –Patients in the waitlist-control group will receive no intervention at first, but nine weeks after IG, they will get the opportunity to also receive yoga therapy for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- oncological disease
- planned to undergo cancer related treatment at radiotherapy outpatient clinic or the interdisciplinary oncological therapy outpatient clinic
- reported fatigue symptoms: (intensity ≥4, impairment ≥ 5).
Key exclusion criteria (3 listed)
- insufficient knowledge of German
- severe emotional or physical impairment
- more than 50km distance to the university hospital which would require travelling.
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 therapyOne yoga session will last one hour. It consists of physical exercises (asanas), conscious breathing (Pranayama) and deep relaxation (Savasana). The subsequent body exercises are structured from lying to sitting to standing. The following sequence of exercises will be repeated in each yoga unit: 1) Relaxation: conscious breathing, body scan, mindfulness 2) Vein pump 3) Pelvis and back rotation (adapted variation of the "nakrasana") 4) Pelvis opening (adapted variation of the "supta baddha konasana") 5) Shoulder bridge ("setu bandha sarvangasana) 6) Forward folds (Paschimottanasana and variations with Pranayama) 7) Backbend: intense east stretch (Purvottasana) 8) Diagonal static yoga cat (Majariasana 1 and resting pose) 9) Standing exercise 10) Upward Salute(Urdhva Hastasana) 11) Warrior 1 (Virabhadrasana 1) 12) Warrior 3 (Virabhadrasana 3) 13) Tree (Vrkasana variation) 14) Relaxation (Savasana). | Behavioural | Yoga group |
Primary outcome
Changes from self-reported fatigue after participation in yoga therapy.
Time frame: T0: At the beginning of the study, T1: after 9 weeks
Self-reported cancer related fatigue; measured with: European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire - Fatigue 13 (EORTC-QLQ-FA13); Scale 1-4; Higher scores mean a higher burden of fatigue
2 secondary outcomes
Changes from Quality of life in cancer patients
Time frame: T0: At the beginning of the study, T1: after 9 weeks
Changes from Depression
Time frame: T0: At the beginning of the study, T1: after 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 31533823Zetzl T, Schuler M, Renner A, Jentschke E, van Oorschot B. Yoga intervention and reminder e-mails for reducing cancer-related fatigue - a study protocol of a randomized controlled trial. BMC Psychol. 2019 Sep 18;7(1):64. doi: 10.1186/s40359-019-0339-3.
- 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.
- Individual participant dataSharing planned: Yes. all individual participant data that underlie results in publication (demographics and clinical characteristics, fatigue, Depression and Quality of life)
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy in people with Fatigue and Cancer, run by Wuerzburg University Hospital at 1 site in Germany.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Oct 2020. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from self-reported fatigue after participation in yoga therapy. (time frame: T0: At the beginning of the study, T1: after 9 weeks). 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 NCT04433793, which also lists 2 linked publications.
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 8 Oct 2020.