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

NCT ID: NCT04585841

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-11-01

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

Cancer patients receiving cannabidiol

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

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

Control group

Cancer patients not receiving cannabidiol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cannabidiol

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

Intervention Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Rikardt Andersen, MD

Role: STUDY_CHAIR

University of Copenhagen

Sebastian W Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

Zealand University Hospital

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

SJ-846

Identifier Type: -

Identifier Source: org_study_id