Pilot Study to Examine Correlation of Nab-Paclitaxel/Gemcitabine Pharmacokinetics with Cachexia

Study on Body Composition and Investigational Treatment Side Effects in Pancreatic Cancer

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to examine the relationship between body composition (i.e. muscle and fat mass) and the side effects of treatment with a commonly used chemotherapy regimen, specifically nab-paclitaxel and gemcitabine, in patients with advanced, metastatic or recurrent pancreatic cancer.

Detailed description of study

The purpose of this study is to examine the relationship between body composition (i.e. muscle and fat mass) and the side effects of treatment with a commonly used chemotherapy regimen, specifically nab-paclitaxel and gemcitabine, in patients with advanced, metastatic or recurrent pancreatic cancer.
Participants will be compensated for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: pancreatic cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
Patients with locally advanced, metastatic or recurrent pancreatic ductal adenocarcinoma (PDAC)
Planned systemic first or second line therapy with Nab-P/G
ECOG Performance Status 0-2
Ability to provide written informed consent and HIPAA authorization
Adequate organ function
Exclusion Criteria
Inability or refusal to receive systemic therapy
Refusal to permit the study team to obtain follow up information from treating physicians? office or perform in person or remote follow up on available records

Updated on 19 Feb 2024. Study ID: 1709056266 (IUSCC-0632)

This study investigates the relationship between body composition, which includes muscle and fat mass, and the side effects experienced by patients undergoing a common chemotherapy treatment. This treatment is used for individuals with advanced, metastatic, or recurrent pancreatic cancer, a condition where cancer cells form in the tissues of the pancreas.

Participants in the study will undergo specific procedures to assess their body composition and monitor any side effects from the chemotherapy regimen. This will help researchers understand how different body compositions might affect the side effects experienced during treatment.

  • Who can participate: Adults with locally advanced, metastatic, or recurrent pancreatic ductal adenocarcinoma may participate. They must be planning to receive first or second line therapy with the specified chemotherapy regimen and have an ECOG Performance Status of 0-2.
  • Study details: Participants will receive an investigational treatment regimen and will be monitored for side effects. The study will involve assessments of muscle and fat mass to see how these factors relate to treatment side effects.

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