Clinical Research Directory

Longitudinal Geriatric Vulnerability, Chemotherapy Toxicity, and Functional Outcomes in Older Adults With Gastrointestinal Cancer

Older adults with gastrointestinal cancers may be more likely to experience side effects from chemotherapy and difficulties with everyday activities. These problems are not always explained by age alone. Changes in nutrition, physical strength, general health, and independence may also affect how well a person tolerates cancer treatment. The purpose of the VITAL-GI study is to better understand how health-related vulnerability in older adults is associated with chemotherapy side effects and changes in daily functioning over time. This is an observational study involving adults aged 65 years or older with gastrointestinal cancer that has not spread to distant parts of the body. Participants receive chemotherapy as part of their usual medical care, either before or after surgery, according to their treatment plan. The study does not assign chemotherapy treatments or change routine care. Researchers use questionnaires and clinical information to assess general health, nutrition, physical abilities, independence, and the risk of chemotherapy side effects. Assessments are performed when chemotherapy begins and approximately 3 and 6 months later. The study examines whether initial health assessments can help identify people who are more likely to experience serious chemotherapy side effects. It also examines how health, daily activities, symptoms, and quality of life change during treatment. The findings may help researchers better understand the supportive care needs of older adults receiving chemotherapy for gastrointestinal cancer.

Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments

The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers. The main question it aims to answer is : Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment? The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests.

Impact of Gonadotoxic Therapies on Fertility

The goal of this observational study is to learn how gonadotoxic treatments (chemotherapies, radiotherapies or immunotherapies) affect the fertility status of participants with cancer. The main questions it aims to answer are: * in females, if cancer therapies reduce the Anti-Müllerian hormone (AMH) concentration (ovarian reserve); * in males, if cancer therapies reduce sperm concentration (sperm quality).

Pilot Study of an NTproBNP Guided Strategy of Cardioprotection

Investigators will evaluate the safety and feasibility of a biomarker-guided cardioprotection strategy using NTproBNP, as compared to usual care, in breast cancer and lymphoma patients treated with anthracyclines.

Investigating Cardiovascular Adverse Events Related to Cancer Treatment

Cisplatin, anthracyclines, bleomycin and trastuzumab can cause severe cardiovascular or pulmonary toxicity. Why some patients are susceptible to extreme toxicity of cancer treatment is largely unknown. Unraveling extreme cardiovascular toxic responses in cancer patients may help understand the pathophysiology of cardiovascular toxicity of these agents and help in understanding the more subtle, long-term cardiovascular side effects that affect a larger part of cancer survivors. With induced pluripotent stem cells we will obtain patient-derived cells to recapitulate and mimic and study pathological (cardiovascular) responses and (cardiovascular) toxicity in vitro.

Dose Optimization and Efficacy Assessment of a Fluoropyrimidine Antidote

Fluoropyrimidines (FLU) are drugs widely used in chemotherapy for various tumors, such as breast, colon, rectal, and gastric cancers. FLU is a drug that inhibits thymine synthesis and, consequently, DNA synthesis, leading to tumor cell death. However, up to 30% of patients treated with FLU experience severe toxicities, depending on the dose and regimen received. The most common symptoms include mucositis, vomiting, nausea, diarrhea, and neutropenia. The enzyme dihydropyrimidine dehydrogenase (DPD) plays a key role in FLU metabolism. Patients with mutations in the DPYD gene (which encodes DPD) are at high risk of experiencing severe toxicities from FLU. Uridine triacetate (UT) is a drug that can be used as an antidote for 5-FU in patients who develop severe toxicities. However, despite its efficacy, it is expensive and not commercially available in Brazil. Currently, the Brazilian population has no access to an antidote for the treatment of FLU-related toxicities. This Phase I/II study will evaluate the dose, safety, and efficacy of compound the association of two molecules as an antidote for grade 3 or higher toxicities resulting from the use of FLU.