Evaluation of Oxaliplatin-Based Chemotherapy for Lean Body Mass Normalization in Patients with Colon Cancer

The primary objective of the study titled "LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy" is to evaluate the impact of lean body mass normalization on the efficacy and safety of oxaliplatin-based chemotherapy in patients with **colon cancer**. This is clinically relevant as optimizing chemotherapy dosing based on lean body mass may enhance treatment outcomes and reduce toxicity, potentially leading to improved patient management and survival rates. No secondary objectives are provided in the available data.

The clinical trial involves participants diagnosed with **colon cancer**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. The trial does not specifically target a vulnerable population. However, the sponsor has not provided information regarding the total number of participants involved in the study. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Additionally, key inclusion or exclusion criteria have not been specified by the sponsor.

The clinical trial is designed to evaluate the effects of **oxaliplatin**-based chemotherapy in patients diagnosed with **colon cancer**. This study is a Phase 4 trial, which typically involves post-marketing surveillance to gather additional information about the drug's risks, benefits, and optimal use. The trial is structured as a randomized, double-blind, controlled study to ensure the reliability and validity of the results. The estimated recruitment start date was December 14, 2017, and the trial is expected to conclude by July 31, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive evaluation to confirm the diagnosis of colon cancer and ensure that participants meet all necessary inclusion criteria while not falling under any exclusion criteria. Following successful screening, participants will be randomly assigned to either the treatment or control group, with neither the participants nor the investigators aware of the group assignments, maintaining the double-blind nature of the study.

Throughout the trial, participants will attend regular follow-up visits to monitor their response to the treatment and to collect data on any adverse events or side effects. These visits are crucial for assessing the primary and secondary endpoints of the study, although specific endpoints are not detailed in the available data. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement will vary depending on individual response to treatment and the occurrence of any adverse events. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigators. The trial's design and procedures are intended to ensure the safety and well-being of participants while providing valuable data on the efficacy of oxaliplatin-based chemotherapy in treating colon cancer.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is categorized as a Phase 4 study, with an estimated recruitment start date of December 14, 2017, and an estimated end date of July 31, 2025. Efficacy assessment details, including specific parameters or endpoints, methods, and schedules for measuring, collecting, and analyzing efficacy data, are not provided in the available data. The trial's primary and secondary endpoints, as well as the main objective, are not specified. Consequently, the description of efficacy assessment cannot include these elements. The trial's focus on evaluating efficacy in a post-marketing setting is implied by its classification as a Phase 4 study.