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

Sponsors

Lead Sponsor: University of Copenhagen

Collaborator: Zealand University Hospital

Source University of Copenhagen
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.

Overall Status Not yet recruiting
Start Date November 1, 2020
Completion Date June 30, 2021
Primary Completion Date March 30, 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of patients with change in lean body mass from baseline. 10 weeks
Secondary Outcome
Measure Time Frame
Change in food intake 10 weeks
Change in energy intake . 10 weeks
Change in protein intake 10 weeks
Change in nausea 10 weeks
Change in emesis 10 weeks
Difference in taste during chemotherapy. 10 weeks
Change in appetite 10 weeks
Change in Quality of life (QOL) 10 weeks
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cannabidiol

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

Arm Group Label: Intervention group

Other Name: No intervention

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Jens Rikardt Andersen, MD

Phone: +4535332504

Email: [email protected]

Location
Facility: Contact: Zealand University Hospital Sebastian W Nielsen
Location Countries

Denmark

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Copenhagen

Investigator Full Name: Jens Rikardt Andersen

Investigator Title: Associate professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention group

Type: Experimental

Description: Cancer patients receiving cannabidiol

Label: Control group

Type: No Intervention

Description: Cancer patients not receiving cannabidiol

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

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

Masking: None (Open Label)

Masking Description: Control group will enter this study if not wanting to participate in cannabidiol study. Due to this masking is not possible.

Source: ClinicalTrials.gov