NCT04585841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

September 10, 2020

Last Update Submit

July 21, 2023

Conditions

Lean Body MassCannabisCancerNauseaCachexiaEmesisAppetitive Behavior

Keywords

CannabidiolCancer cachexiaNauseaEmesisLean Body MassOxaliplatinPaclitaxelAppetiteAdultQuality of lifeTaste alteration

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 weeks

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Cancer patients receiving cannabidiol

Drug: Cannabidiol

Control group

NO INTERVENTION

Cancer patients not receiving cannabidiol

Interventions

CannabidiolDRUG

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

Also known as: No intervention
Intervention group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant
  • Breastfeeding
  • Unable to complete patient reported outcomes (PRO)-measurements
  • Previously received taxanes or platinum-based chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Marijuana AbuseNeoplasmsNauseaCachexiaVomitingAppetitive BehaviorDysgeusia

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightThinnessBehavior, AnimalBehaviorTaste DisordersSensation DisordersNeurologic ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Jens Rikardt Andersen, MD

    University of Copenhagen

    STUDY CHAIR

  • Sebastian W Nielsen, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Control group will enter this study if not wanting to participate in cannabidiol study. Due to this masking is not possible.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 10, 2020

First Posted

October 14, 2020

Study Start

December 1, 2020

Primary Completion

August 30, 2021

Study Completion

November 1, 2022

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

DK(1)