Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate delta-9-tetrahydrocannabinol's (THC) ability to increase food intake and improve food enjoyment for advanced cancer patients with taste and/or smell (chemosensory) abnormalities.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cannabis Use in Cancer Patients

NCT03617692

Solid Tumor, Adult

COMPLETED

Cannabis For Cancer-Related Symptoms

NCT03948074

Pain Nausea Anxiety +1 more

COMPLETED PHASE2

Patient Reported Symptom Control With THC or CBD Use

NCT04875286

Cancer-Associated Pain Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

ACTIVE_NOT_RECRUITING

Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients

NCT03339622

Cancer Chronic Pain Due to Malignancy (Finding)

TERMINATED PHASE3

Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors

NCT05672342

Breast Carcinoma Chemotherapy-Induced Peripheral Neuropathy Colon Carcinoma

WITHDRAWN EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Appetite stimulants are the common treatment for cancer-induced anorexia. However, only 30% of advanced cancer patients respond and benefit from appetite stimulants, which may be due in part to sensory abnormalities, as a person who is experiencing food aversion due to taste and smell changes may be unable to respond to these agents. Of the appetite stimulants available for use in clinical practice only Marinol, or THC, has the potential to increase food intake by improving appetite as well as by amplifying the taste of food through the brain's reward pathway.

A 22-day, double blind, randomized, placebo-controlled trial will be conducted. Participants will start at 2.5mg of THC or placebo once daily for the first 3 days and then increase to 2.5mg of THC or placebo twice daily before lunch and supper. Participant's will complete the following survey tools pre and post-treatment: Taste and Smell Survey to assess the severity and change in chemosensory complaint scores; 3-day dietary record to determine the change in caloric intake and shift in food preference by macronutrient analysis; 24-hour urine collections to validate the 3-day dietary record; Satiety Labelled Intensity Magnitude scale for subjective appetite ratings; Food Preference Checklist to assess objective shifts in macronutrient and flavor preferences; Functional Assessment of Anorexia/Cachexia Therapy questionnaire to assess participant's QOL; interview to determine the cause and effects of chemosensory alterations; Edmonton Symptom Assessment Scale to assess nausea; and Side Effect Survey to document the tolerability of the drug (post-treatment only). Participants will complete the survey tools with the aid of the researcher. All tools are short and easy to complete, which minimizes patient burden.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Anorexia Taste Disorders Olfactory Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type ACTIVE_COMPARATOR

Marinol (Dronabinol)

Intervention Type DRUG

Intervention description: Marinol (drug) is being used as an appetite stimulant for treatment of cancer-induced anorexia.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Marinol (Dronabinol)

Intervention description: Marinol (drug) is being used as an appetite stimulant for treatment of cancer-induced anorexia.

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* advanced cancer patients (defined as locally recurrent or metastatic) over 18 years old with a decreased food intake for at least 2 weeks (reported by physician or subject)
* able to complete questionnaires in English
* able to provide informed consent
* life expectancy of greater than 2 months (as determined by physician)
* chemosensory complaint score \> 1

Exclusion Criteria

* receiving enteral or parenteral feedings
* allergies or sensitivity to THC and/or sesame seed oil
* history of substance abuse or psychotic episodes
* mechanical obstruction of alimentary tract, mouth or nose
* received chemotherapy in the last 2 weeks
* received radiation therapy to the head/neck area
* brain tumor
* nausea score greater than 5 on ESAS
* history of tachyarrhythmias, angina pectoris or hypertension
* current diagnosis of liver impairment
* use of marijuana within 30 days prior to start of trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No