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Study on Triptorelin for Fertility Protection in Young Women and Teenagers Undergoing Chemotherapy for Breast Cancer, Leukemia, Lymphomas, and Sarcomas

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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 young women and teenagers with certain types of cancer, including breast cancer, acute leukemia, lymphomas (both Hodgkin and non-Hodgkin), and sarcomas (such as osteosarcoma, soft tissue sarcoma, and Ewing sarcoma). The study is investigating the use of a treatment called GnRHa (Gonadotropin-Releasing Hormone agonist) during chemotherapy. The purpose of the study is to explore whether GnRHa can help protect fertility in these patients by looking at changes in the ovarian reserve, which is a measure of a woman's remaining egg supply, after chemotherapy.

Participants in the study will receive either the GnRHa treatment or a placebo, which is a substance with no active medication. The GnRHa treatment being studied is called Pamorelin, which is given as an injection. There are two different doses of Pamorelin being used in the study: 3.75 mg and 11.25 mg. The study will follow participants for several years to monitor their ovarian reserve and other health factors. This includes measuring levels of a hormone called Anti-Müllerian Hormone (AMH), which helps indicate the number of eggs left in the ovaries, at various points after the end of chemotherapy.

Throughout the study, participants will have regular check-ups to assess their ovarian reserve and overall health. This will involve tests like ultrasounds and blood tests to measure hormone levels. The study aims to provide valuable information on how GnRHa might help preserve fertility in young women and teenagers undergoing cancer treatment. By understanding the effects of this treatment, researchers hope to improve future care for patients facing similar challenges.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to one of two groups: the GnRHa group or the placebo group. This assignment is done to compare the effects of the medication with a placebo, which is a substance with no active drug.
You will receive either Pamorelin 3.75 mg or Pamorelin 11.25 mg as a prolonged-release suspension for injection, or a placebo. The injections are administered through a method called intramuscular use, which means the medication is injected into a muscle.
Step 2
Treatment phase
During the treatment phase, you will receive the assigned injection at regular intervals as determined by the study protocol. The exact dosage and frequency will depend on the group you are assigned to.
This phase is designed to assess the impact of the medication on your ovarian reserve during chemotherapy treatment for cancer.
Step 3
End of treatment (EoT)
At the end of the treatment phase, various assessments will be conducted to evaluate the effects of the medication. These assessments include measuring levels of Anti-Müllerian Hormone (AMH), which is an indicator of ovarian reserve.
Additional tests may include measuring other hormones and conducting ultrasound examinations to assess ovarian function.
Step 4
Follow-up period
After the end of treatment, you will enter a follow-up period. During this time, your ovarian reserve and other health indicators will be monitored at specific intervals: 6 months, 12 months, and annually up to 5 years after the end of treatment.
The follow-up assessments will include hormone level measurements, ultrasound examinations, and evaluations of your overall health and quality of life.
Step 5
Final assessment
At the end of the follow-up period, a final assessment will be conducted to evaluate the long-term effects of the treatment on your ovarian reserve and overall health.
The results will help determine the effectiveness of the medication in protecting fertility during chemotherapy.

Who can join the trial?

6 criteria

Signed informed consent: You need to agree to participate in the study by signing a document that explains the study details.
Age 14-42 years at cancer diagnosis: You must have been diagnosed with cancer between the ages of 14 and 42.
Female subjects with breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin), or sarcomas (osteo, soft tissue, and Ewing) confirmed by histology and assigned for disease-specific chemotherapy: You must be a woman with one of these types of cancer, confirmed by a tissue test, and scheduled to receive chemotherapy specific to your disease.
Confirmed menarche: You must have started your menstrual periods.
ECOG performance status 0-1: This is a scale used to assess how well you can perform daily activities. A score of 0-1 means you are fully active or have some symptoms but can still carry out light work.
Adequate bone marrow, renal, hepatic, and cardiac functions and absence of other uncontrolled medical or psychiatric disorders: Your blood, kidney, liver, and heart functions must be normal, and you should not have any other uncontrolled medical or mental health issues.

Who cannot join the trial?

4 criteria

Patients who are not women cannot participate in the study.
Patients who do not have **breast cancer**, **acute leukemia**, **lymphomas** (both **Hodgkin** and **non-Hodgkin**), or **sarcomas** (including **osteosarcoma**, **soft tissue sarcoma**, and **Ewing sarcoma**) cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are considered part of a vulnerable population cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Karolinska University Hospital
Verified
Solna, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden
Soedersjukhuset AB
Responsive
Stockholm, Sweden

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Investigated drugs

GnRHa is a type of medication used in this clinical trial to help protect fertility in young women and teenagers who are undergoing chemotherapy for cancer. This medication works by temporarily putting the ovaries to rest, which may help shield them from the harmful effects of chemotherapy. The goal is to preserve the ability to have children in the future by maintaining the health of the ovaries during cancer treatment.

Triptorelin

What is already known about the treatment

GnRHa – GnRHa, or Gonadotropin-Releasing Hormone agonists, are administered through injections and are currently being studied for their role in protecting fertility in young women and teenagers undergoing chemotherapy for cancers such as breast cancer, acute leukemia, lymphomas, and sarcomas. In medical literature, GnRHa is being evaluated for its ability to preserve ovarian function by maintaining the ovarian reserve, as measured by the Anti-Müllerian Hormone (AMH) levels, after chemotherapy. The main therapeutic indication for GnRHa in this context is fertility protection during cancer treatment. At the molecular level, GnRHa works by temporarily suppressing ovarian function, which may protect the ovaries from the damaging effects of chemotherapy. It is classified pharmacologically as a hormone therapy.

Investigated diseases

Breast Cancer
Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. The growth of cancer cells can form a lump or mass in the breast. Over time, the cancer may invade surrounding tissues and organs. The progression can vary greatly among individuals.
Acute Leukemia
Acute leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal white blood cells. These cells crowd out normal blood cells, leading to symptoms like fatigue, infections, and bleeding. The disease progresses quickly and requires prompt medical attention. As it advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression rate can differ based on the specific type of acute leukemia.
Hodgkin Lymphoma
Hodgkin lymphoma is a cancer of the lymphatic system, which is part of the immune system. It is marked by the presence of Reed-Sternberg cells. The disease often starts in the lymph nodes and can spread to other lymph nodes and organs. As it progresses, it can cause symptoms such as swollen lymph nodes, fever, and weight loss. The spread of the disease can affect the body's ability to fight infections. The progression can vary depending on the stage and individual factors.
Non-Hodgkin Lymphoma
Non-Hodgkin lymphoma is a diverse group of blood cancers that affect the lymphatic system. It involves the uncontrolled growth of lymphocytes, a type of white blood cell. The disease can start in any part of the lymphatic system and may spread to other organs. Symptoms can include swollen lymph nodes, fever, and night sweats. The progression of non-Hodgkin lymphoma can be slow or aggressive, depending on the specific type. The disease can impact the body's immune response over time.
Osteosarcoma
Osteosarcoma is a type of bone cancer that usually starts in the long bones, such as those in the arms and legs. It is characterized by the production of immature bone by cancer cells. The disease can cause pain and swelling in the affected area. As it progresses, it may spread to other bones or organs, such as the lungs. The growth of the tumor can weaken the bone, leading to fractures. The rate of progression can vary among individuals.
Soft Tissue Sarcoma
Soft tissue sarcoma is a cancer that begins in the soft tissues of the body, such as muscles, fat, and blood vessels. It can occur anywhere in the body but is most common in the arms, legs, and trunk. The disease often presents as a painless lump or swelling. As it progresses, it can invade nearby tissues and spread to other parts of the body. The growth of the tumor can affect the function of the affected area. The progression can differ based on the type and location of the sarcoma.