Clinical trial NCT05416697: Effectiveness of Cannabinoids on Appetite in Scleroderma
Official title: Effectiveness of Cannabinoid on Appetite, Sleep Quality, Quality of Life, Joint Pain, and Cytokine Level in Systemic Sclerosis Patients: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Sclerosis
Malnutrition
Loss of Appetite
Keywords: cannabinoid
appetite
quality of life
systemic sclerosis
scleroderma
clinical trial
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cannabinoid versus placebo
Primary purpose: TREATMENT

Brief summary: The cannabinoid has benefits in many aspects but the evidence of the effect of cannabinoids in humans with SSc is limited. We, therefore, would like to investigate the efficacy of cannabinoids on the appetite, sleep efficiency, quality of life, pain, and critical cytokine level in SSc compared with placebo in SSc patients and the adverse events associated with cannabinoids in those patients.

Detailed description: Systemic sclerosis (SSc) is a connective tissue disease for which skin tightness is the hallmark. The disease is classified into 2 major subsets: limited cutaneous systemic sclerosis (lcSSc) and diffuse cutaneous systemic sclerosis (dcSSc) depending on the extent of skin tightness. Not only the skin tightness but also the internal organs such as the musculoskeletal, kidneys, lungs, heart, and intestines can be involved and associated with a poor outcome. Malnutrition and/or weight loss is a complications in SSc. The complication is possibly related to gastrointestinal involvement, inflammation, immunosuppressant agents, or mood disturbance which can affect the food appetite or eating behavior. As well as sleep quality, sleep disturbance has been reported in SSc patients and the associated factor of sleep disturbance in those patients was gastrointestinal involvement, particularly gastroesophageal reflux disease, the severity of pain, and depressed mood. The cannabinoid is an agent which affects appetite, pain, and sleep quality as mentioned above, hence it would improve the appetite, get a high sleep quality and reduce pain associated with musculoskeletal involvement in SSc patients.

Although cannabinoid has benefit in many aspects, they also resulted in serious adverse events after cannabinoid inhalation, including ischemic stroke related to vasospasm of the cerebral vessel, high cardiac output, cardiac arrhythmias, blood pressure fluctuation, and respiratory tract infection. Acute toxicity has been reported and depended on unit dose, tolerance, and route of cannabinoid use. Cannabis also influenced brain function including memory, and cognitive function, and expanded the risk for psychosis in those who had prolonged use. The symptoms of central nervous system (CNS) toxicity include euphoria, panic, agitation, mood alterations, alteration of perception, loss of social inhibition, muscle incoordination, myoclonic jerking, ataxia, slurred speech, and risk of the suicidal idea. In addition, prolonged high doses of cannabis use can lead to the development of cannabinoid hyperemesis syndrome caused by cyclic hyperemesis, finally resulting in electrolyte disturbances and impaired kidney function.

Because the evidence of the effect of cannabinoids in humans with SSc is limited. We, therefore, would like to investigate the efficacy of cannabinoids on the appetite, sleep efficiency, quality of life, pain, and key cytokine level in SSc compared with placebo in SScpatientst and the adverse events associated with cannabinoids in those patients.

Eligibility criteria: Inclusion Criteria:

1. SSc patients aged between 18 and 70 years
2. Diagnosed according to ACR/EULAR 2013 classification criteria
3. Having anorexia or malnutrition status
4. Must not receive steroid equivalent to prednisolone dose more than 10 mg/d
5. Must receive a stable dose of steroid, immunosuppressant, and/or vitamin or its supplement within 2 weeks before enrollment
6. Must stop anxiolytics, hypnotics, or sleeping pills at least 2 weeks before enrollment
7. Understand and able to read and write the Thai language

Exclusion Criteria:

1. Overlap with other connective tissue diseases
2. Pregnancy or lactation
3. Bedridden and confined to no self-care
4. Evidence of active malignant disease
5. Present uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatic, or renal diseases (Cr\>1.4 mg/dl)
6. Present active infection that needs systemic antibiotic
7. Previous allergy to cannabinoid or their derivatives
8. Concomitant illegal drug used (amphetamine or its derivative, cocaine)
9. History of the previous cannabinoid using or concomitant any herbal included cannabinoid used
10. On-going anxiolytics, hypnotics, or sleeping pills used
11. In a period that needs immunosuppressant dose adjustment
12. Having active SSc that needs closed monitoring for disease progression (pulmonary hypertension, proteinuria, microscopic hematuria, digital gangrene, and progressive interstitial lung disease)
13. Having unstable cardiopulmonary disease (angina, peripheral vascular disease, cerebrovascular disease, and arrhythmia) and risk of cardiovascular disease
14. Having a history of schizophrenia, concurrent active mood disorder, or anxiety disorders
15. Receiving the following medications that cause drug interaction with cannabinoids: fluoroquinolone, rifampicin, fluoxetine, warfarin

Primary outcomes:
measure: The changing of appetite
timeFrame: 4 weeks
Secondary outcomes:
measure: The changing of serum transferrin level
timeFrame: 4 weeks
measure: An adverse event
timeFrame: 4 weeks
Other outcomes:
measure: The changing of sleep quality
timeFrame: 4 weeks
measure: The changing of quality of life
timeFrame: 4 weeks
measure: The changing pain symptoms
timeFrame: 4 weeks
measure: The changing of cytokine level (transforming growth factor beta)
timeFrame: 4 weeks
Locations:
city: Khon Kaen
country: Thailand
facility: Department of Medicine, Faculty of Medicine, Khon Kaen University
city: Khon Kaen
country: Thailand
facility: Scleroderma Clinic, Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Khon Kaen University
name: Chingching Foocharoen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: