Clinical trial NCT04585841: The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy
Official title: The Effect of Medical Cannabidiol on Lean Body Mass in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lean Body Mass
Cannabis
Cancer
Nausea
Cachexia
Emesis
Appetitive Behavior
Keywords: Cannabidiol
Cancer cachexia
Nausea
Emesis
Lean Body Mass
Oxaliplatin
Paclitaxel
Appetite
Adult
Quality of life
Taste alteration
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2020-10-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of cancer
* Fulfill criteria for starting chemotherapy
* Must be able to stand upright
* Have the possibility of contact by telephone
* No previous treatment with taxanes or platinums
* Scheduled to undergo lest 4 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy
* If female and fertile, must have been menopausal for 1 year or negative pregnancy test at inclusion and use approved contraceptive measures

Exclusion Criteria:

* Pregnant
* Breastfeeding
* Unable to complete patient reported outcomes (PRO)-measurements
* Previously received taxanes or platinum-based chemotherapy
* Use of cannabinoids. If in use, treatment must be stopped 4 days prior to inclusion
* If using any anti epileptic or antidepressant medicine. Treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. However, any treatment with Clobazam is not allowed due to major interaction with cannabidiol.

Primary outcomes:
measure: Number of patients with change in lean body mass from baseline.
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in food intake
timeFrame: 10 weeks
measure: Change in energy intake .
timeFrame: 10 weeks
measure: Change in protein intake
timeFrame: 10 weeks
measure: Change in nausea
timeFrame: 10 weeks
measure: Change in emesis
timeFrame: 10 weeks
measure: Difference in taste during chemotherapy.
timeFrame: 10 weeks
measure: Change in appetite
timeFrame: 10 weeks
measure: Change in Quality of life (QOL)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: University of Copenhagen
name: Jens Rikardt Andersen, MD
role: STUDY_CHAIR
affiliation: Zealand University Hospital
name: Sebastian W Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References: