The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Appetitive Behavior
- Cachexia
- Cancer
- Cannabis
- Emesis
- Lean Body Mass
- Nausea
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Cancer patients entering a phase 2 trial on cannabis for prevention on chemotherapy-induced peripheral neuropathy are asked to enter this study monitoring cannabidiols effect on lean body mass during chemotherapy. 40 participants are expected to enter intervention group, 20 participants in control group.Masking: None (Open Label)Masking Description: Control group will enter this study if not wanting to participate in cannabidiol study. Due to this masking is not possible.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
One of the side effects of chemotherapy is loss of lean body mass. With a non-blinded two armed intervention design this study will examine the effect of cannabidiol on fat free mass in cancer patients. The study will include patients who are diagnosed with cancer and scheduled to undergo at least 4...
One of the side effects of chemotherapy is loss of lean body mass. With a non-blinded two armed intervention design this study will examine the effect of cannabidiol on fat free mass in cancer patients. The study will include patients who are diagnosed with cancer and scheduled to undergo at least 4 courses of paclitaxel or oxaliplatin based chemotherapy. The hypothesis is that patients receiving cannabidiol (300mg/day) will have no change in lean body mass at the end of the study. In extension to this, we hypothesize that cannabidiol will increase the energy and protein intake because of increased appetite and decreased nausea and emesis. Recruitment and data collection will take place at the department of Clinical Oncology at Zealand University Hospital, Roskilde. Each patient will be included for four courses of paclitaxel or oxaliplatin based chemotherapy. The length between each chemotherapy course is three weeks. Lean body mass will be measured by impedance spectroscopy before every chemotherapy treatment. For two and a half months, patients will answer a weekly questionnaire about nausea, appetite and quality of life in general. The questionnaire is developed for this study. In addition to the questionnaire, the patients will be interviewed about their daily dietary intake to quantify their energy and protein intake, calculated as percentage of estimated need. Another side effect of chemotherapy is alterations in taste. In this study, we will examine the patient's taste in sweet and salty. At the day of chemotherapy, the patients will have a taste test. In the taste test the patients must tell which of the basic flavors they presume they are consuming, as well as how strong the taste is , on a scale from 1 to 10.
Tracking Information
- NCT #
- NCT04585841
- Collaborators
- Zealand University Hospital
- Investigators
- Study Chair: Jens Rikardt Andersen, MD University of Copenhagen Principal Investigator: Sebastian W Nielsen, MD Zealand University Hospital
Get Well Soon