Clinical trial NCT06747039: Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study
Official title: ObServational StUdy of CaNnabis ExtRact in FIbromyalgia SyndromE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia (FM)
Keywords: fibromyalgia
cannabis
pain
fatigue
quality of life
sleep disturbances
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients afferent to IRCCS Ospedale Galeazzi Sant- Ambrogio in Milan (Italy) with FIbromyalgia Syndrome who will start therapy with cannabis extract Avextra 10/10.

Brief summary: The aim of this observational study is to evaluate the effects of cannabis extract Avextra 10/10 solution on pain, fatigue, sleep, and quality of life among patients affected by fibromyalgia (FM) syndrome. The main question it aims to answer is:

Does cannabis extract have a positive effect on pain after 12 weeks in these patients?

Participants diagnosed from FM will be evaluated and will fill survey about their pain, fatigue, sleep, anxiety, depression and quality of life at baseline, 4 weeks, 8 weeks and 12 weeks after the initiation of cannabis extract Avextra 10/10 solution.

Detailed description: Fibromyalgia (FM) is a chronic condition characterized by widespread pain, mechanical hyperalgesia, fatigue, sleep disturbances, psychological and cognitive impairments, mood changes, headaches, migraines, and gastrointestinal symptoms. Despite its recognition as a medical condition with diagnostic criteria and severity scales, its exact causes and effective treatment remain unclear. FM significantly impacts patients' quality of life and poses a societal burden due to high direct and indirect costs.

Cannabis-based treatments have gained attention for FM symptom management. In Italy, therapeutic cannabis has been legal since 2013 and may be prescribed when conventional treatments fail or cause intolerable side effects. Its primary components, tetrahydrocannabinol (THC) and cannabidiol (CBD), interact with cannabinoid receptors to potentially provide pain relief, anti-inflammatory effects, and mood stabilization.

The study aims to evaluate the efficacy of the standardized cannabis extract Avextra 10/10 (10 mg/mL THC and 10 mg/mL CBD) for FM treatment.

Objectives Primary objective: -Assess the extract's impact on pain after 12 weeks.

Secondary objective:

* Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on fatigue, sleep, anxiety and depression after 4, 8 and 12 weeks among patients affected by FM
* Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 4 and 8 weeks among patients affected by FM.
* Evaluate the effect of cannabis extract Avextra 10/10 solution on the quality of life at 4, 8 and 12 weeks among patients affected by FM.
* Describe any adverse events or the principal reasons of drug discontinuation.

Design and Methods This is a monocentric observational prospective study in which patients with FM who undertake cannabis therapy with cannabis extract Avextra 10/10 solution will consecutively be recruited.

Population: The inclusion criteria are:

* Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria \[2\].
* Patients with FM prescribed cannabis extract Avextra 10/10 solution after failure and/or intolerance of first- or second-line treatment.
* Aged 18 years and older.
* Able to fully understand and fill questionnaires.
* Able to provide informed consent, according to requirements of local IRB/ethics committee.

The exclusion criteria are:

* Known history of pain not due to FM.
* Patients who have not received stable therapy for pain, sleep disorders, or any psychiatric condition for at least 2 weeks.
* Patients who are taking other types of medical cannabis besides Avextra 10/10 solution.
* Concomitant diagnosis of other pathologies that could interfere with clinical judgment.
* Psychiatric diagnosis according to DSM-V-TR

All patients with FM will undergo a standard clinical assessment, at baseline and at the follow-up visits, as part of the routine clinical practice. After the baseline visit, corresponding to the appointment where medical cannabis is prescribed within two weeks before the undertake of cannabis extract, follow-up visits will be scheduled according to routine clinical practice as follow:

* 15 days after the undertake of cannabis extract (T15)
* 30 days after the undertake of cannabis extract (T30)
* 60 days after the undertake of cannabis extract (T60)
* 90 days after the undertake of cannabis extract (T90)
* 6 months after the undertake of cannabis extract. All patients with FM will undergo a standard clinical assessment, at baseline and at the follow-up visits, as part of the routine clinical practice.

Data collected from participants during clinical evaluations at baseline visit will include:

* Demographic data: age, gender, BMI, residence
* Educational qualification
* Occupational status
* Age at menopause (if applicable)
* Current medication
* Comorbidities
* Symptom duration
* Age at FM diagnosis
* Number of sure tender point
* Smoke status
* Physical activity

Data collected from participants during clinical evaluations at follow-up visit will include:

* Number of sure tender point
* Smoke status
* Physical activity
* Efficacy or side effects of cannabis extract
* Discontinuation of cannabis extract

Conclusion The study seeks to establish the feasibility and clinical effects of a standardized cannabis extract for FM, addressing a critical gap in treatment strategies. Further research is needed to validate its efficacy and optimize FM management.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria.
* Patients with FM prescribed cannabis extract Avextra 10/10 solution after failure and/or intolerance of first- or second-line treatment.
* Aged 18 years and older.
* Able to fully understand and fill questionnaires.
* Able to provide informed consent, according to requirements of local IRB/ethics committee.

Exclusion Criteria:

* Known history of pain not due to FM.
* Patients who have not received stable therapy for pain, sleep disorders, or any psychiatric condition for at least 2 weeks.
* Patients who are taking other types of medical cannabis besides Avextra 10/10 solution.
* Concomitant diagnosis of other pathologies that could interfere with clinical judgment.
* Psychiatric diagnosis according to DSM-V-TR
* Pregnancy or breastfeeding

Primary outcomes:
measure: Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM
timeFrame: 12 weeks
Secondary outcomes:
measure: Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on sleep quality among patients affected by FM using Pittsburgh sleep quality index (PSQI)
timeFrame: 4, 8 and 12 weeks
measure: Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain using Widespread pain indexWPI
timeFrame: 4, 8 and 12 weeks
measure: Evaluate the effect of cannabis extract Avextra 10/10 solution on the quality of life using The Italian versions of the Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: 4, 8 and 12 weeks
measure: Describe any adverse events or the principal reasons of drug discontinuation.
timeFrame: 4,8,12 weeks
measure: 1. Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM
timeFrame: 4, 8 weeks
measure: Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on Functional Appreciation Scale (FAS)
timeFrame: 4, 8, 12 weeks
measure: Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on Symptom Severity Scale (SSS)
timeFrame: 4, 8, 12 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
Study officials:
affiliation: IRCCS Ospedale Galeazzi Sant'Ambrogio
name: Piercarlo Sarzi Puttini, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.
citation: Pozzi G, Frustaci A, Tedeschi D, Solaroli S, Grandinetti P, Di Nicola M, Janiri L. Coping strategies in a sample of anxiety patients: factorial analysis and associations with psychopathology. Brain Behav. 2015 Aug;5(8):e00351. doi: 10.1002/brb3.351. Epub 2015 Jun 24.
citation: Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.
citation: Cerea S, Todd J, Ghisi M, Mancin P, Swami V. Psychometric properties of an Italian translation of the Functionality Appreciation Scale (FAS). Body Image. 2021 Sep;38:210-218. doi: 10.1016/j.bodyim.2021.04.007. Epub 2021 May 4.
citation: Salaffi F, Franchignoni F, Giordano A, Ciapetti A, Sarzi-Puttini P, Ottonello M. Psychometric characteristics of the Italian version of the revised Fibromyalgia Impact Questionnaire using classical test theory and Rasch analysis. Clin Exp Rheumatol. 2013 Nov-Dec;31(6 Suppl 79):S41-9. Epub 2013 Jun 26.
citation: Sotoodeh R, Waldman LE, Vigano A, Moride Y, Canac-Marquis M, Spilak T, Gamaoun R, Kalaba M, Hachem Y, Beaulieu P, Desroches J, Ware MA, Perez J, Shir Y, Fitzcharles MA, Martel MO. Predictors of Pain Reduction Among Fibromyalgia Patients Using Medical Cannabis: A Long-Term Prospective Cohort Study. Arthritis Care Res (Hoboken). 2023 Jul;75(7):1588-1594. doi: 10.1002/acr.24985. Epub 2023 Feb 3.
citation: Aster HC, Evdokimov D, Braun A, Uceyler N, Sommer C. Analgesic Medication in Fibromyalgia Patients: A Cross-Sectional Study. Pain Res Manag. 2022 Sep 22;2022:1217717. doi: 10.1155/2022/1217717. eCollection 2022.
citation: Chaves C, Bittencourt PCT, Pelegrini A. Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Pain Med. 2020 Oct 1;21(10):2212-2218. doi: 10.1093/pm/pnaa303.
citation: Giorgi V, Bongiovanni S, Atzeni F, Marotto D, Salaffi F, Sarzi-Puttini P. Adding medical cannabis to standard analgesic treatment for fibromyalgia: a prospective observational study. Clin Exp Rheumatol. 2020 Jan-Feb;38 Suppl 123(1):53-59. Epub 2020 Feb 5.
citation: Mazza M. Medical cannabis for the treatment of fibromyalgia syndrome: a retrospective, open-label case series. J Cannabis Res. 2021 Feb 17;3(1):4. doi: 10.1186/s42238-021-00060-6.
citation: Kurlyandchik I, Tiralongo E, Schloss J. Safety and Efficacy of Medicinal Cannabis in the Treatment of Fibromyalgia: A Systematic Review. J Altern Complement Med. 2021 Mar;27(3):198-213. doi: 10.1089/acm.2020.0331. Epub 2020 Dec 8.
citation: Cameron EC, Hemingway SL. Cannabinoids for fibromyalgia pain: a critical review of recent studies (2015-2019). J Cannabis Res. 2020 May 29;2(1):19. doi: 10.1186/s42238-020-00024-2.
citation: Walitt B, Fitzcharles MA, Hassett AL, Katz RS, Hauser W, Wolfe F. The longitudinal outcome of fibromyalgia: a study of 1555 patients. J Rheumatol. 2011 Oct;38(10):2238-46. doi: 10.3899/jrheum.110026. Epub 2011 Jul 15.
citation: Giorgi V, Sirotti S, Romano ME, Marotto D, Ablin JN, Salaffi F, Sarzi-Puttini P. Fibromyalgia: one year in review 2022. Clin Exp Rheumatol. 2022 Jun;40(6):1065-1072. doi: 10.55563/clinexprheumatol/if9gk2. Epub 2022 Jun 22.
citation: Martinez JE, Guimaraes I. "Fibromyalgia - are there any new approaches?". Best Pract Res Clin Rheumatol. 2024 Mar;38(1):101933. doi: 10.1016/j.berh.2024.101933. Epub 2024 Feb 13.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
citation: Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
citation: Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.