UKT HT03_1Recruiting

Assessment of Quality of Life in Female Patients with Locally Recurrent Breast Cancer During Hyperthermia-Radiation Therapy

Gender
Women
Age
18 years and older
Trial type
Observational
Line of therapy
Relapsed / refractory
Phase

What is this trial about?

The standard treatment for early-stage breast cancer typically involves breast-conserving surgery followed by radiation therapy. The goal of the UKT HT03_1 study is to evaluate the quality of life of patients undergoing hyperthermia-supported radiation therapy (heat-supported radiation therapy). Patients who have experienced a local recurrence of breast cancer following surgery are eligible to participate in the study.

Trial flow

Requirements

Diagnosis: breast cancer

Age: 18 years and older

Line of therapy: Rezidiv / primär refraktär

Key inclusion criteria: local recurrence of breast cancer after close R0, R1 or R2 resection; local inoperability

Allocation

Einarmigen Studie

Treatment

Evaluation of health-related Quality of Life and the intensity of fatigue after radiotherapy in combination with hyperthermia of the chest wallFatigue Questionnaires at the end of the hypertermic radiotherapy and during follow-up after 3 and 12 month and then annually up to year 5 (EORTC QLQ-C30, EORTC QLQ - BR 23, FACT - B + 4 and FACIT - Fatigue Questionnaires)

Follow-up

60 months

Detailed description

Breast cancer is a disease in which cells in the breast multiply uncontrollably. If the tumor is detected early and has not yet formed metastases, the standard treatment usually consists of breast-conserving surgery. Depending on the individual situation, this may be followed by chemotherapy and, in most cases, radiation therapy to eliminate any remaining cancer cells. However, the tumor may return in the same location after surgery; this is referred to as a local recurrence. If the tumor recurs, treatment options are limited, and any additional therapy can be physically and emotionally taxing. Hyperthermia treatment is a complementary procedure in cancer therapy in which the tumor tissue is selectively heated. The goal is to make the cancer cells more sensitive to radiation. Hyperthermia is used in an attempt to improve the effectiveness of radiation therapy without significantly impairing quality of life.

The objective of this study is to investigate the impact of combined treatment with radiation therapy and hyperthermia on the quality of life of patients with recurrent breast cancer (local recurrence). This is a prospective study, meaning it assesses treatment success in advance, and is being conducted at a single center, the University Hospital of Tübingen. Quality of life is assessed using standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-BR23, FACT-B, and FACIT-Fatigue). Data collection takes place at the end of hyperthermic radiation therapy and during follow-up at 3 and 12 months, and subsequently annually through the 5th year after treatment.

Eligible participants are women aged 18 and older with locally recurrent breast cancer confirmed by tissue biopsy (histologically), which has either been reoperated on or is inoperable. Patients with spread to other organs (metastases) and a life expectancy of less than 2 years, or those with serious health problems such as severe heart disease or recent heart surgery, are excluded from the study.

Facts

  1. What condition: Breast cancer (mammary carcinoma)
  2. Cancer characteristics: locally recurrent, following a marginal R0, R1, or R2 resection, or locally inoperable recurrence
  3. What the study investigates: Quality of life with hyperthermia-supported radiation therapy
  4. Study objective: To assess and improve quality of life and fatigue
  5. Study duration: Total duration: 5 years; follow-up at 3 and 12 months after completion of treatment, then annually (up to 5 years)
  6. Study characteristics: prospective observational study with a single treatment arm, non-randomized

Trial sites

1 trial site in Germany is listed.

  • Universitätsklinikum Tübingen

    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 (NCT04878666) 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.