Efficacy of a tooth foam and oral spray containing Cannabis sativa and Basella alba seed oil in reducing oral mucositis and xerostomia in patients receiving radiotherapy: An open-label randomized controlled trial

Efficacy of a tooth foam and oral spray containing Cannabis sativa and Basella alba seed oil in reducing oral mucositis and xerostomia in patients receiving radiation therapy: A randomized controlled clinicaltrial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250521002

Enrollment

Registered

2025-05-21

Start date

2025-05-23

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with head and neck cancer who are receiving radiotherapy, ASA class I or II oral mucositis, head and neck cancer, radiotherapy, radiation therapy, Cannabis saltiva, Basella alba,tooth foam

Interventions

normal toothpaste,tooth foam containing Cannabis sativa and Basella alba ,tooth foam and oral spray containing Cannabis sativa and Basella alba

No Intervention No treatment,Experimental Other,Experimental Other

control group,tooth foam,tooth foam and oral spray

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Over the age of 20 2. Receiving radiation therapy at least 45 Gy 3. ASA I or II 4.Presence of dry mouth symptoms

Exclusion criteria

Exclusion criteria: 1.Severe underlying health conditions that cannot be managed 2.Dementia or impaired cognitive and communicative abilities 3.The existence of oral pain/ burning sensations resulting from other causes 4.Smokers or ceased smoking for less than one year 5.History of allergic reactions to any ingredient found in products

Design outcomes

Primary

Measure	Time frame
VAS of pain day 0 and 14 days after end of the intervention visual analog scale,VAS of oral dryness day 0 and 14 days after end of the intervention visual analog scale,WHO scale day 0 and 14 days after end of the intervention WHO Oral Mucositis Grading Scale ,Actual moisture levels day 0 and 14 days after end of the intervention Measured by the moisture checking device	—

Secondary

Measure	Time frame
RTOG-EORTC scoring day 0 and 14 days after end of the intervention RTOG-EORTC scoring system for late radiation-induced morbidity of salivary glands,Oral hygiene day 0 and 14 days after end of the intervention OHI-simplified index (OHI-S),Inhibit Candida spp. growth day 0 and 14 days after end of the intervention numbers of Candida Spp. colonies from oral rinse	—

Countries

Thailand

Contacts

Public ContactJitjiroj Ittichaicharoen

CMU

Jitjiroj.itti@cmu.ac.th053944451

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026