Efficacy and mechanisms of cannabis oil for alleviating side effects of breast cancer chemotherapy (CBC2) : protocol for randomized controlled trial
© 2024. The Author(s)..
BACKGROUND: In a pilot study using both cannabidiol (CBD) and tetrahydrocannabinol (THC) as single agents in advanced cancer patients undergoing palliative care in Thailand, the doses were generally well tolerated, and the outcome measure of total symptom distress scores showed overall symptom benefit. The current study aims to determine the intensity of the symptoms experienced by breast cancer patients, to explore the microbiome profile, cytokines, and bacterial metabolites before and after the treatment with cannabis oil or no cannabis oil, and to study the pharmacokinetics parameters and pharmacogenetics profile of the doses.
METHODS: A randomized, double-blinded, placebo-controlled trial will be conducted on the breast cancer cases who were diagnosed with breast cancer and currently receiving chemotherapy at King Chulalongkorn Memorial Hospital (KCMH), Bangkok, Thailand. Block randomization will be used to allocate the patients into three groups: Ganja Oil (THC 2 mg/ml; THC 0.08 mg/drop, and CBD 0.02 mg/drop), Metta Osot (THC 81 mg/ml; THC 3 mg/drop), and placebo oil. The Edmonton Symptom Assessment System (ESAS), Food Frequency Questionnaires (FFQ), microbiome profile, cytokines, and bacterial metabolites will be assessed before and after the interventions, along with pharmacokinetic and pharmacogenetic profile of the treatment during the intervention.
TRIAL REGISTRATION: TCTR20220809001.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:24 |
|---|---|
| Enthalten in: |
BMC complementary medicine and therapies - 24(2024), 1 vom: 23. März, Seite 130 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Thu, May Soe [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
19GBJ60SN5 |
|---|
| Anmerkungen: |
Date Completed 25.03.2024 Date Revised 25.03.2024 published: Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1186/s12906-024-04426-0 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM370114981 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM370114981 | ||
| 003 | DE-627 | ||
| 005 | 20240325235650.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240324s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1186/s12906-024-04426-0 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1347.xml |
| 035 | |a (DE-627)NLM370114981 | ||
| 035 | |a (NLM)38521934 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Thu, May Soe |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and mechanisms of cannabis oil for alleviating side effects of breast cancer chemotherapy (CBC2) |b protocol for randomized controlled trial |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 25.03.2024 | ||
| 500 | |a Date Revised 25.03.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a BACKGROUND: In a pilot study using both cannabidiol (CBD) and tetrahydrocannabinol (THC) as single agents in advanced cancer patients undergoing palliative care in Thailand, the doses were generally well tolerated, and the outcome measure of total symptom distress scores showed overall symptom benefit. The current study aims to determine the intensity of the symptoms experienced by breast cancer patients, to explore the microbiome profile, cytokines, and bacterial metabolites before and after the treatment with cannabis oil or no cannabis oil, and to study the pharmacokinetics parameters and pharmacogenetics profile of the doses | ||
| 520 | |a METHODS: A randomized, double-blinded, placebo-controlled trial will be conducted on the breast cancer cases who were diagnosed with breast cancer and currently receiving chemotherapy at King Chulalongkorn Memorial Hospital (KCMH), Bangkok, Thailand. Block randomization will be used to allocate the patients into three groups: Ganja Oil (THC 2 mg/ml; THC 0.08 mg/drop, and CBD 0.02 mg/drop), Metta Osot (THC 81 mg/ml; THC 3 mg/drop), and placebo oil. The Edmonton Symptom Assessment System (ESAS), Food Frequency Questionnaires (FFQ), microbiome profile, cytokines, and bacterial metabolites will be assessed before and after the interventions, along with pharmacokinetic and pharmacogenetic profile of the treatment during the intervention | ||
| 520 | |a TRIAL REGISTRATION: TCTR20220809001 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Breast Cancer | |
| 650 | 4 | |a Cannabis | |
| 650 | 4 | |a Microbiota | |
| 650 | 4 | |a Quality of Life | |
| 650 | 7 | |a Cannabidiol |2 NLM | |
| 650 | 7 | |a 19GBJ60SN5 |2 NLM | |
| 650 | 7 | |a Cytokines |2 NLM | |
| 700 | 1 | |a Pongpirul, Krit |e verfasserin |4 aut | |
| 700 | 1 | |a Vongsaisuwon, Mawin |e verfasserin |4 aut | |
| 700 | 1 | |a Vinayanuwattikun, Chanida |e verfasserin |4 aut | |
| 700 | 1 | |a Banchuen, Kamonwan |e verfasserin |4 aut | |
| 700 | 1 | |a Ondee, Thunnicha |e verfasserin |4 aut | |
| 700 | 1 | |a Payungporn, Sunchai |e verfasserin |4 aut | |
| 700 | 1 | |a Phutrakool, Phanupong |e verfasserin |4 aut | |
| 700 | 1 | |a Nootim, Preecha |e verfasserin |4 aut | |
| 700 | 1 | |a Chariyavilaskul, Pajaree |e verfasserin |4 aut | |
| 700 | 1 | |a Cherdchom, Sarocha |e verfasserin |4 aut | |
| 700 | 1 | |a Wanaratna, Kulthanit |e verfasserin |4 aut | |
| 700 | 1 | |a Hirankarn, Nattiya |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t BMC complementary medicine and therapies |d 2020 |g 24(2024), 1 vom: 23. März, Seite 130 |w (DE-627)NLM306156547 |x 2662-7671 |7 nnns |
| 773 | 1 | 8 | |g volume:24 |g year:2024 |g number:1 |g day:23 |g month:03 |g pages:130 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1186/s12906-024-04426-0 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 24 |j 2024 |e 1 |b 23 |c 03 |h 130 | ||