Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer

Breast Cancer Clinical Trial

— OnkoFit I  

Official title:

Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506476
• Other study ID #: OnkoFit I
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2025

Study information

• Verified date: August 2020
• Source: University Hospital Tuebingen
• Contact: Cihan Gani, MD, PD
• Phone: +49 (0) 7071 29-82165
• Email: cihan.gani[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 201
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
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.

Locations

Country	Name	City	State
Germany	University Hospital Tübingen, Department of Radiation Oncology	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 Months after completion of adjuvant radiotherapy of breast cancer