OnkoFit IRecruiting

Exercise Training to Combat Symptoms of Fatigue During Radiation Therapy for Breast Cancer

Gender
Women
Age
18 years and older
Trial type
Interventional
Line of therapy
First line
Phase

What is this trial about?

The standard treatment for early-stage breast cancer typically involves breast-conserving surgery followed by radiation therapy. However, symptoms of fatigue may occur as a side effect of radiation therapy. The goal of the OnkoFit I study is to investigate whether targeted exercise training using a fitness tracker can reduce symptoms of fatigue during radiation therapy. Women aged 18 and older with breast cancer who are physically capable of exercising and are scheduled to receive radiation therapy after surgery are eligible to participate.

Trial flow

Requirements

Diagnosis: breast cancer

Age: 18–99 years

Key inclusion criteria: women; indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery or complete breast resection

Allocation

Randomisierung

Treatment

approx. 8 weeks
fitness tracker + briefing booklet + in-person briefing + step goals
fitness tracker + briefing booklet + in-person briefingwithout weekly goals
briefing booklet + in-person briefingcontrol arm with no activity tracker

Follow-up

3 months

Detailed description

Breast cancer (mammary carcinoma) is a malignant disease of the mammary gland tissue characterized by uncontrolled proliferation of mammary gland cells. Treatment of the disease depends on numerous factors, such as the patient’s general health, the stage of the disease, as well as certain biological characteristics of the tumor, such as the growth rate (Ki-67 index), detectable hormone receptors, and the increased presence of HER2 receptors on the cells.

Treatment for early-stage breast cancer (stages 1–2) typically involves breast-conserving surgery with the goal of complete recovery. In many cases, and depending on certain risk factors, further treatment (adjuvant therapy) may be administered after surgery to reduce the risk of residual disease or recurrence. Radiation therapy is one treatment option in this context. The goal is to damage the cancer cells using high-energy radiation. A common side effect of radiation therapy is so-called fatigue—a persistent physical and mental exhaustion that is not alleviated by sleep or rest.

The aim of this study is to investigate whether targeted physical exercise, supported by a fitness tracker, can alleviate this fatigue. The idea behind this is that regular exercise improves energy balance, strengthens the immune system, and thus enhances quality of life during cancer treatment. As part of the study, patients will be randomly assigned to three groups. Group 1 will receive a fitness tracker, a guidance booklet, and personalized counseling on exercise therapy. Each week, a new step goal will be set, working toward a daily average of 6,000 steps. Group 2 also receives the tracker and the guidance booklet and records their daily steps themselves, but without step goals or weekly feedback. Group 3 receives only the introductory booklet and a consultation, but no tracker. The study’s primary focus is on assessing feelings of fatigue during exercise therapy. This is measured using a recognized questionnaire (FACIT-F) three months after the completion of radiation therapy.

Eligible participants are women aged 18 and older with breast cancer who have undergone breast-conserving surgery or complete mastectomy and are scheduled to receive radiation therapy afterward. Patients must not have any severe cardiovascular diseases or movement disorders. Participation is also excluded if the patient is currently enrolled in other studies or is pregnant.

Facts

  1. Disease: Breast cancer (breast carcinoma)
  2. Cancer characteristics: Tumor surgically removed and adjuvant radiation therapy planned
  3. What the study investigates: Effect of fitness tracker-supported exercise training on fatigue
  4. Study objective: To improve symptoms of fatigue following radiation therapy
  5. Study duration: 3 months after completion of radiation therapy
  6. Study characteristics: three groups, randomized, open-label (unblinded), fitness tracker as the intervention

Trial sites

2 trial sites in Germany are listed.

  • Charité – Universitätsmedizin Berlin

    Grosse Hamburger Strasse 5-11, 10115 Berlin

    Recruiting
  • Universitätsklinikum Tübingen

    Geissweg 3, 72076 Tübingen

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT04506476) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.