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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585841
• Other study ID #: SJ-846
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 1, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appetitive Behavior
• Cachexia
• Cancer
• Cannabis
• Emesis
• Lean Body Mass
• Nausea

Intervention

Drug:
• Cannabidiol
Patients will receive cannabidiol in the period of time they receive chemotherapy.

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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