Breast CancerOnkoFit INCT04506476
Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer
A study testing Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C in people with Breast Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This randomized three-arm trial will test the benefit in terms of cancer related fatigue of an activity tracker based exercise training during adjuvant radiotherapy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2020to 1 Aug 2025
- 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
- Capacity for consent
- Minimum age 18
- Presence of breast cancer
- ECOG 0-2
- Indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery or Ablatio mammae
Who cannot join
- Participation in any other interventional study
- Pregnancy
- Contraindication against physical activity/sport and others
- Severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy in the last 6 months, congestive heart failure NYHA > I°)
- preexisting diseases with are relevantly accompanied by a limited mobility in patients (e.g. paraparesis of the lower limbs)
- ECOG Status 3-4
- prior use of activity trackers
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Baden-Wurttemberg, 72076
Daniel Zips, MD, Prof, +49 (0) 7071 29-85990, ro-info@med.uni-tuebingen.de
Cihan Gani, MD, +49 (0)7071 29-82165, cihan.gani@med.uni-tuebingen.de
About this study
Official title: Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)
This randomized three-arm trial will test the benefit in terms of cancer related fatigue of an activity tracker based exercise training during adjuvant radiotherapy in breast cancer patients.
Read the detailed description
This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in breast cancer patients on the fatigue syndrome during adjuvant radiotherapy. Quality of Life and the intensity of fatigue will be documented with the fatigue subscale of the FACIT Questionnaire three months after adjuvant radiotherapy.
- Conditions
- Breast Cancer
- Being tested
- Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C
- Keywords
- Fatigue, activity tracker, Radiotherapy, Exercise
- Medical subject headings
- Breast Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, CDevice
Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Activity tracker with weekly goals | Experimental | Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. We suggest a daily step-count which should improve the patients physical activity during radiotherapy of breast cancer. Patients receive weekly feedback and a new goal with the aim to reach a total of 6000 daily steps, which should be then maintained during radiotherapy. Receives: Device: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C |
| Activity tracker without Weekly goals | Experimental | Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy.
The patients self-document their daily step count during radiotherapy, there will be no recommendation for the daily count of steps. Receives: Device: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C |
| Control arm with no activity tracker | No intervention | Patients receive a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. A fitness tracker will not be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome
This endpoint will be evaluated by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale of the FACIT questionnaire (Physical well-being values 0-28, 28 worse outcome; social/family well-being values 0-28, 28 better outcome; emotional well-being values 0-24, 24 worse outcome; functional well being values 0-28, 28 better outcome; additional factors values 0-64, 64 worse outcome
Measured: 3 Months after completion of adjuvant radiotherapy of breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Aug 2020
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2025 (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 Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cihan Gani, University Hospital Tuebingen
- Investigators
- Cihan Gani, MD, PD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506476
- Sponsor's protocol ID
- OnkoFit I
- Acronym
- OnkoFit I
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hauth F, Gehler B, Niess AM, Fischer K, Toepell A, Heinrich V, Roesel I, Peter A, Renovanz M, Hartkopf A, Stengel A, Zips D, Gani C. An Activity Tracker-Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials). JMIR Res Protoc. 2021 Sep 22;10(9):e28524. doi: 10.2196/28524.
PubMed 34550079
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)
- ClinicalTrials.gov ID
- NCT04506476
- Acronym / sponsor ID
- OnkoFit I / OnkoFit I
- Conditions
- Breast Cancer
- Keywords
- Fatigue, activity tracker, Radiotherapy, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 10 Aug 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.
This randomized three-arm trial will test the benefit in terms of cancer related fatigue of an activity tracker based exercise training during adjuvant radiotherapy in breast cancer patients.
Detailed description
This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in breast cancer patients on the fatigue syndrome during adjuvant radiotherapy. Quality of Life and the intensity of fatigue will be documented with the fatigue subscale of the FACIT Questionnaire three months after adjuvant radiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Activity tracker with weekly goals | Experimental | Device: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, CPatients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. We suggest a daily step-count which should improve the patients physical activity during radiotherapy of breast cancer. Patients receive weekly feedback and a new goal with the aim to reach a total of 6000 daily steps, which should be then maintained during radiotherapy. |
| Activity tracker without Weekly goals | Experimental | Device: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, CPatients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. The patients self-document their daily step count during radiotherapy, there will be no recommendation for the daily count of steps. |
| Control arm with no activity tracker | No intervention | –Patients receive a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. A fitness tracker will not be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capacity for consent
- Minimum age 18
- Presence of breast cancer
- ECOG 0-2
- Indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery or Ablatio mammae
Key exclusion criteria (7 listed)
- Participation in any other interventional study
- Pregnancy
- Contraindication against physical activity/sport and others
- Severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy in the last 6 months, congestive heart failure NYHA > I°)
- preexisting diseases with are relevantly accompanied by a limited mobility in patients (e.g. paraparesis of the lower limbs)
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 |
|---|---|---|
| Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, CPatients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy. | Device | Activity tracker with weekly goals, Activity tracker without Weekly goals |
Primary outcome
Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome
Time frame: 3 Months after completion of adjuvant radiotherapy of breast cancer
This endpoint will be evaluated by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale of the FACIT questionnaire (Physical well-being values 0-28, 28 worse outcome; social/family well-being values 0-28, 28 better outcome; emotional well-being values 0-24, 24 worse outcome; functional well being values 0-28, 28 better outcome; additional factors values 0-64, 64 worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Derived from this study: PubMed 34550079Hauth F, Gehler B, Niess AM, Fischer K, Toepell A, Heinrich V, Roesel I, Peter A, Renovanz M, Hartkopf A, Stengel A, Zips D, Gani C. An Activity Tracker-Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials). JMIR Res Protoc. 2021 Sep 22;10(9):e28524. doi: 10.2196/28524.
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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.
Cihan Gani, MD, PD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C in people with Breast Cancer, run by University Hospital Tuebingen 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 5 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 17 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cihan Gani, MD, PD (+49 (0) 7071 29-82165, cihan.gani@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome (time frame: 3 Months after completion of adjuvant radiotherapy of breast cancer). 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 NCT04506476, 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 17 Aug 2020.