Lean Body MassPhase 1NCT04585841
The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy
A Phase 1 study testing Cannabidiol in people with Lean Body Mass and Cannabis, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lean Body Mass, Cannabis, Cancer
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2020to 1 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Cannabidiol
- Keywords
- Cannabidiol, Cancer cachexia, Nausea, Emesis, Lean Body Mass, Oxaliplatin, Paclitaxel, Appetite, Adult, Quality of life, Taste alteration
- Medical subject headings
- Marijuana Abuse, Neoplasms, Nausea, Cachexia, Vomiting, Appetitive Behavior, Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called No intervention
Patients will receive cannabidiol in the period of time they receive chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Cancer patients receiving cannabidiol Receives: Drug: Cannabidiol |
| Control group | No intervention | Cancer patients not receiving cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Dec 2020
- Primary completion30 Aug 2021
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lean Body MassStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens Rikardt Andersen, MD, Study chair, University of CopenhagenSebastian W Nielsen, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585841
- Sponsor's protocol ID
- SJ-846
- Status last verified
- Jul 2023
- First submitted
- 10 Sep 2020
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medical Cannabidiol on Lean Body Mass in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy
- ClinicalTrials.gov ID
- NCT04585841
- Acronym / sponsor ID
- SJ-846
- Keywords
- Cannabidiol, Cancer cachexia, Nausea, Emesis, Lean Body Mass, Oxaliplatin, Paclitaxel, Appetite
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Zealand University Hospital
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: CannabidiolCancer patients receiving cannabidiol |
| Control group | No intervention | –Cancer patients not receiving cannabidiol |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: No interventionPatients will receive cannabidiol in the period of time they receive chemotherapy. | Drug | Intervention group |
Primary outcome
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.
8 secondary outcomes
Change in food intake
Time frame: 10 weeks
Change in energy intake .
Time frame: 10 weeks
Change in protein intake
Time frame: 10 weeks
Change in nausea
Time frame: 10 weeks
Change in emesis
Time frame: 10 weeks
Difference in taste during chemotherapy.
Time frame: 10 weeks
Change in appetite
Time frame: 10 weeks
Change in Quality of life (QOL)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Rikardt Andersen, MD study chair
University of Copenhagen
Sebastian W Nielsen, MD principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabidiol in people with Lean Body Mass and Cannabis, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with change in lean body mass from baseline. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.