Clinical trial

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

Name

SJ-846

Description

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.

Trial arms

Trial start

2020-12-01

Estimated PCD

2021-08-30

Trial end

2022-11-01

Status

Completed

Phase

Early phase I

Treatment

Cannabidiol

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

Arms:

Intervention group

Other names:

No intervention

Size

Primary endpoint

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

10 weeks

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Control group will enter this study if not wanting to participate in cannabidiol study. Due to this masking is not possible.'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

Updated at

2023-07-24

1 organization

1 drug

7 indications

Organization

University of Copenhagen

Drug

cannabidiol

Indication

lean body mass

Indication