NEOPRO-SITRecruiting

Prehabilitation — Targeted Exercise Therapy and Psycho-Oncological Support Before Cancer Treatment

Gender
Women and men
Age
18–65 years
Trial type
Interventional
Line of therapy
all
Phase

What is this trial about?

For patients with malignant tumors, good physical and psychological resilience is important during treatment. The current standard of care includes treatment of the cancer itself; however, structured programs designed to specifically prepare patients for their upcoming therapy are not yet a regular part of care. The goal of the NEOPRO-SIT study is to develop a structured prehabilitation program and to investigate whether targeted exercise therapy and structured psycho-oncological care can improve the physical performance and psychological well-being of patients with solid tumors. Women and men between the ages of 18 and 65 with a solid tumor (including breast cancer) who are scheduled to undergo treatment with surgery or radiation therapy with the goal of a cure are eligible to participate in this study.

Detailed description

Solid tumors are a type of cancer characterized by malignant tissue growths that form in organs such as the breast, lung, or intestine. Depending on the type and stage of the disease, various methods are used to treat solid tumors, including surgery, radiation therapy, and drug therapies. This phase can be very stressful both physically and emotionally, as side effects such as fatigue, muscle weakness, and psychological stress may occur. For this reason, patients’ physical and emotional resilience is of great importance and can influence the success of treatment. The current standard of care includes treatment of the cancer itself; however, structured preparation for the upcoming therapy has not yet been routinely established.

The aim of this study is to investigate the added benefit of a targeted prehabilitation program during this phase. Prehabilitation means that patients are prepared for the procedure through targeted measures even before surgery or radiation therapy. The program includes supervised exercise training as well as structured psycho-oncological support aimed at alleviating anxiety and strengthening psychological resilience. Patients are divided into two groups: The control group receives regular medical care (standard treatment), while the study group additionally receives the structured prehabilitation program with exercise therapy and psycho-oncological support. Assignment is not random but sequential. The study is open-label, meaning that both the patients and the study physicians are aware of the group assignment. The primary outcome is measured using a 6-minute walk test, which assesses physical performance 14 to 28 days after surgery or radiation therapy. In addition, muscle strength, mental well-being, anxiety, depression, and quality of life are assessed over a period of up to 6 months following the procedure.

Eligible participants include women and men aged 18 to 65 with a solid tumor (including breast cancer) who are scheduled to undergo curative treatment using a combined (multimodal) therapy approach, along with surgery or radiation therapy. Patients must be physically fit enough to participate and have sufficient language skills to understand questionnaires and exercise instructions. Patients with severe heart or lung disease are not eligible to participate.

Facts

  1. What condition: solid tumors (including breast cancer)
  2. Cancer characteristics: curative treatment intent with planned surgery or radiation therapy
  3. What the study investigates: potential benefits of a structured exercise and psycho-oncological care program prior to actual cancer treatment
  4. Study objective: To determine whether the structured prehabilitation program can improve patients’ physical performance and mental well-being before and after cancer treatment
  5. Study duration: 6 months (expected to run through October 2029)
  6. Study characteristics: interventional, non-randomized, sequential, open-label (unblinded), two study arms

Trial sites

1 trial site in Germany is listed.

  • Universitätsklinikum Münster

    48149 Münster

    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 (NCT07464457) 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.