The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy

The Effect of Medical Cannabidiol on Lean Body Mass in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Nausea; Cannabis; Cachexia; Appetitive Behavior; Emesis; Lean Body Mass
• Intervention / Treatment: Drug: Cannabidiol

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Cancer patients receiving cannabidiol	Drug: Cannabidiol; Patients will receive cannabidiol in the period of time they receive chemotherapy.; Other Names: No intervention
No Intervention: Control group; Cancer patients not receiving cannabidiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with change in lean body mass from baseline.	Changes in lean body mass measured at baseline and before each chemotherapy treatment (scheduled for every three weeks) measured in kg by bioimpedance. Changes are assessed as change in percentage of total lean body mass weight.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in food intake	Change in food intake from baseline measured in kilojoule (kJ). Changes in intake of protein- and energy assessed by weekly nutritional recall interviews of weekly intake. Change in food intake from baseline measured in kJ. Changes in intake of protein- and energy assessed by weekly nutritional recall interviews of weekly intake.	10 weeks
Change in energy intake .	Change in intake of energy assessed by weekly nutritional 24-hour recall interview. Assessment of energy requirement using Harris Benedict- formula estimated from height in cm, weight in kilo, age in years and physical activity level (PAL). Height and weight is derived from bioimpedance measurements in Outcome 1. Age is derived from conversation with the participant. PAL is assessed after conversation with the participant. Energy requirements will be reported as kilojoule (Kj). Correlation between relative fulfilment of energy requirement, and change therein. Energy requirement is estimated by Harris-Benedict formula, including among other assessment of physical activity level.	10 weeks
Change in protein intake	Change in protein intake from baseline measured in kJ Protein requirement is estimated from the Danish Health Authority´s recommendation for adult patients. Protein intake is assessed by 24-hour recall of nutrition intake.	10 weeks
Change in nausea	Changes in nausea from baseline is assessed by a categorical scale in a weekly questionnaire if the participant is experiencing nausea: daily, five or six times a week, three or four times a week, one or two times a week, not at all. "Not at all" being the lowest score, "Daily" being the highest. The Questionnaire is written in danish and is called Livskvalitet (Quality of life) and the scale is for the question "Symptomer" (symptoms). The questionnaire is developed for this study and language validation has been done with 12 patients from the same department as the study will take place	10 weeks
Change in emesis	Changes in emesis from baseline is assessed by a categorical scale in a weekly questionnaire if the participant is experiencing nausea: daily, five or six times a week, three or four times a week, one or two times a week, not at all. "Not at all" being the lowest score, "Daily" being the highest. The Questionnaire is written in danish and is called Livskvalitet (Quality of life) and the scale is for the question "Symptomer" (symptoms). The questionnaire is developed for this study and language validation has been done with 12 patients from the same department as the study will take place.	10 weeks
Difference in taste during chemotherapy.	Difference in taste from baseline is measured by a sensory test with flavour neutral mashed potato added sweet, sour or umami flavour in two strengths of flavour. Participants will answer which flavour they taste and how strong the flavour is on a scale from 1-10. Also the patients preference in the three flavours will be monitored.	10 weeks
Change in appetite	Changes in appetite from baseline is assessed by a categorical scale in a weekly questionnaire about the patient's subjective estimation on portion size: bigger, the same or smaller than usual compared to the weekly nutritional 24-hour recall interview. Bigger being the highest value, smaller than usual being the lowest value.	10 weeks
Change in Quality of life (QOL)	To estimate the patient' QOL from baseline by a weekly questionnaire about the patient's well being. It will be compared with the questions about appetite, taste, nausea and emesis. It will also be compared with the patient medical record. The Questionnaire is written in danish and is called Livskvalitet (Quality of life) and the scale is for the question "Symptomer" (symptoms). The questionnaire is developed for this study and language validation has been done with 12 patients from the same department as the study will take place	10 weeks

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Zealand University Hospital
• Investigators: Study Chair: Jens Rikardt Andersen, MD, University of Copenhagen; Principal Investigator: Sebastian W Nielsen, MD, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Nausea; Adult; Paclitaxel; Oxaliplatin; Appetite; Cannabidiol; Emesis; Cancer cachexia; Lean Body Mass; Taste alteration
• Additional Relevant MeSH Terms: Metabolic Diseases; Signs and Symptoms, Digestive; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Thinness; Nausea; Wasting Syndrome; Cachexia; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: SJ-846

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No