The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy
Condition: Lean Body Mass; Cannabis; Cancer; Nausea; Cachexia; Emesis; Appetitive Behavior
MeSH terms: Wasting Syndrome; Nausea; Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      An intervention study on the effect of cannabidiol on lean body mass in cancer patients
      receiving chemotherapy, at the department of Clinical Oncology at Zealand University
      Hospital, Roskilde, Denmark. Fat free mass will be measured by bioimpedance spectroscopy. As
      secondary outcomes protein and energy intake, nausea, taste alterations and life quality will
      be assessed by oral interviews and questionnaires.
    

Detailed 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 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.
    

Intervention name(s): Cannabidiol
Intervention type(s): Drug
Intervention description(s): Patients will receive cannabidiol in the period of time they receive chemotherapy.
Other intervention name(s): No intervention
Intervention MeSH terms: Cannabidiol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Supportive Care
Keywords: Cannabidiol; Cancer cachexia; Nausea; Emesis; Lean Body Mass; Oxaliplatin; Paclitaxel; Appetite; Adult; Quality of life; Taste alteration