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Study on Improving Quality of Life for Early Breast Cancer Patients Using Duloxetine and Furosemide to Manage Endocrine Therapy-Related Pain

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on improving the quality of life for patients with early-stage breast cancer who are experiencing symptoms related to their endocrine therapy. The study is specifically looking at patients with ER-positive HER2-negative breast cancer in stages I-II. The trial will explore the effectiveness of two medications, duloxetine and furosemide, in managing pain associated with endocrine therapy, such as joint pain, muscle pain, and bone pain.

The purpose of the study is to determine if either duloxetine or furosemide can better control these types of pain over a period of three months. Participants will be randomly assigned to receive one of these medications or a placebo. The study will last for up to six months, during which participants will take the medication orally. The trial aims to assess changes in pain levels and overall quality of life using specific questionnaires designed to measure these aspects.

Throughout the study, participants will be monitored for any changes in their symptoms and overall health. The trial will also evaluate the safety of the medications by tracking any side effects or adverse events. The ultimate goal is to find supportive treatments that can help patients manage the side effects of their cancer therapy, thereby improving their quality of life during treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Complete baseline assessment using patient-reported questionnaires: EORTC QLQ-C30 and EORTC QLQ-BR42.

    Ensure all eligibility criteria are met, including age, ongoing endocrine therapy, and adequate organ function.

    Confirm the presence of endocrine therapy-related musculoskeletal pain, evaluated as at least grade 2.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to one of two treatment groups: duloxetine or furosemide.

    Both medications are administered orally.

  3. Step 3

    Treatment phase

    Receive the assigned medication: duloxetine or furosemide.

    Continue the current endocrine therapy throughout the study duration.

    Monitor and report any changes in musculoskeletal pain and other symptoms.

  4. Step 4

    Evaluation at 3 months

    Assess changes in musculoskeletal pain using the EORTC QLQ-BR42 questionnaire.

    Evaluate global health status and quality of life using the EORTC QLQ-C30 questionnaire.

    Review any adverse events or side effects experienced during the treatment.

  5. Step 5

    Evaluation at 6 months

    Reassess changes in musculoskeletal pain and quality of life.

    Evaluate emotional functioning and endocrine therapy symptoms.

    Continue monitoring for any adverse events or side effects.

  6. Step 6

    Completion of study

    Conclude participation in the study after the final evaluation at 6 months.

    Discuss any further treatment options or follow-up care as needed.

Who can join the trial?

17 criteria

  • Must be a female (both pre- and postmenopausal) or male patient.
  • Must have completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ-BR42).
  • Must provide written informed consent before registration, following international and local regulations.
  • If capable of having children, must agree to use at least one highly effective birth control method until stopping treatment.
  • Women who can have children must have a negative pregnancy test within 7 days before the first dose of study treatment.
  • If breastfeeding, must stop nursing before the first dose of study treatment and until 1 month after the last treatment.
  • Must be at least 18 years old.
  • Must be undergoing ongoing adjuvant endocrine therapy (ET) for ER positive HER2 negative breast cancer stages I-III.
  • Must have received at least 3 months and up to 3 years of ET and plan to continue the same ET during the study.
  • Adjuvant treatment with CDK4/6 inhibitors or PARP inhibitors is allowed if planned to continue during the study.
  • Must have endocrine therapy related musculoskeletal (MSK) pain (joint pain, bone pain, or muscle pain) evaluated by the doctor as at least moderate for at least 4 weeks before joining the study.
  • Previous chemotherapy is allowed if completed at least 3 months before joining the study.
  • Must have an ECOG performance status of 0-2, which means being fully active or having some limitations but able to carry out light work.
  • Must have adequate organ function, including:
    • A glomerular filtration rate (a measure of kidney function) of at least 30 mL/min/1.73m².
    • Potassium levels of at least 3.0 mmol/L.
    • Sodium levels of at least 130 mmol/L.
    • Total bilirubin less than 1.5 times the upper limit of normal, or less than 3 times for those with Gilbert’s disease.

Who cannot join the trial?

5 criteria

  • Patients with any other type of cancer besides ER positive HER2 negative breast cancer stages I-II cannot participate. This means the cancer must be a specific type that is sensitive to hormones and does not have a protein called HER2.
  • Patients who are not experiencing endocrine therapy related MSK pain cannot participate. This refers to muscle, joint, or bone pain caused by hormone treatments.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not female cannot participate. The study is specifically for female patients.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

  • Duloxetine

    is a medication often used to treat depression and anxiety. In this trial, it is being tested to see if it can help control muscle and joint pain, such as arthralgias, myalgias, and bone pain, which are related to endocrine therapy in patients with early breast cancer.

  • Furosemide

    is a medication commonly used to reduce fluid retention and swelling caused by various medical conditions. In this trial, it is being evaluated to determine if it can help manage muscle and joint pain associated with endocrine therapy in patients with early breast cancer.

What is already known about the treatment

  • Duloxetine

    Duloxetine is administered orally in the form of capsules. It is currently used in medicine to manage pain and improve quality of life in patients undergoing endocrine therapy for early-stage breast cancer. The main therapeutic indication is to alleviate musculoskeletal pain, including joint and muscle pain, associated with endocrine therapy. At the molecular level, duloxetine works by inhibiting the reuptake of serotonin and norepinephrine, which are neurotransmitters involved in pain modulation. It is classified pharmacologically as a serotonin-norepinephrine reuptake inhibitor (SNRI).

  • Furosemide

    Furosemide is typically administered orally in tablet form or intravenously. In the context of this clinical trial, it is being evaluated for its potential to relieve musculoskeletal pain in patients receiving endocrine therapy for early-stage breast cancer. The main therapeutic indication is to manage pain related to endocrine therapy, such as joint and muscle pain. Furosemide acts by inhibiting the reabsorption of sodium and chloride in the kidneys, leading to increased urine production and reduced fluid retention, which may help alleviate pain. It is classified as a loop diuretic.

Investigated diseases

ER Positive HER2 Negative Breast Cancer Stages I-II – This type of breast cancer is characterized by the presence of estrogen receptors (ER) and the absence of human epidermal growth factor receptor 2 (HER2) on the cancer cells. It typically occurs in the early stages, specifically stages I and II, where the cancer is localized to the breast or nearby lymph nodes. The cancer cells grow in response to estrogen, which can influence the progression of the disease. In these stages, the cancer is generally considered to be more treatable and may not have spread extensively. The progression can vary, but it often involves the growth of the tumor within the breast tissue and potentially to nearby lymph nodes. Monitoring and managing symptoms related to endocrine therapy, such as musculoskeletal pain, are important aspects of care.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513442-10-00Protocol codeEORTC 2237-BCG-QLGEstimated enrolment399 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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