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NCT Number: NCT04585841

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

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Key information

Conditions

Lean Body Mass Appetitive Behavior Behavior Behavior, Animal Body Weight Body Weight Changes Cachexia Cancer Cannabis Chemically-Induced Disorders Dysgeusia Emesis Marijuana Abuse Mental Disorders Nausea Neoplasms Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders Taste Disorders Thinness Vomiting Weight Loss

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zealand University Hospital

Roskilde, 4000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol

Drug

Patients will receive cannabidiol in the period of time they receive chemotherapy.

Other names: No intervention

Primary outcomes

  1. Number of patients with change in lean body mass from baseline.

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. Change in food intake

    Time frame: 10 weeks

    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.

  2. Change in energy intake .

    Time frame: 10 weeks

    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.

  3. Change in protein intake

    Time frame: 10 weeks

    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.

  4. Change in nausea

    Time frame: 10 weeks

    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

  5. Change in emesis

    Time frame: 10 weeks

    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.

  6. Difference in taste during chemotherapy.

    Time frame: 10 weeks

    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.

  7. Change in appetite

    Time frame: 10 weeks

    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.

  8. Change in Quality of life (QOL)

    Time frame: 10 weeks

    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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Zealand University Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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