Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Unstimulated whole salivary flow rate
Study Overview
Brief Summary
Dry mouth leads to debilitating symptoms 24/7. The two primary causes for dry mouth are Sjögrens disease and after radiotherapy of a head and neck cancer. Former clinical trials have investigated mesenchymal stem cell treatment for dry mouth with promising results. However, few of the participants evolved normal salivary flow rate. Therefore, in this randomized clinical trial, two treatments of mesenchymal stem cells are administered, 4 months apart. This has not been done before.
The hypothesis is that two treatments of mesenchymal stem cells results in a higher salivary flow rate and ameliorate symptoms from dry mouth.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
One research assistant preparing the treatments are unmasked
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity
- •WHO Performance status 0-1
- •Presence of xerostomia daily
- •UWS of 0.05 mL/min to 0.5 ml/min
- •Age above 18
- •Informed consent
- •0.5 year follow-up of the cancers in
- •with no recurrence
Exclusion Criteria
- •Any malignant cancer diagnosis excluding head and neck cancers
- •Xerogenic medications at inclusion
- •Penicillin or streptomycin allergy assessed by health personnel
- •Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)
- •Previous submandibular surgery or biopsy
- •Pregnancy or planned pregnancy until 4 months after second treatment
- •Breastfeeding
- •Smoking within the last 6 months
- •Alcohol abuse within the last 6 months (consumption must not be above 10 units/week (Danish National board health alcohol guidelines)
Arms & Interventions
Mesenchymal Stem Cells
Treatment with intraglandular injections in both submandibular glands with allogeneic adipose derived mesenchymal stem cells
Intervention: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (Drug)
Placebo
Treatment with intraglandular injections in both submandibular glands sterile isotonic saline water
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Unstimulated whole salivary flow rate
Time Frame: T=0 months, T=4 months and T=8 months (primary endpoint assessed after 8 months)
Unstimulated whole salivary flow rate measured in mL/min
Secondary Outcomes
- Stimulated whole salivary flow rate(T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).)
- Patient-Reported Outcome of xerostomia: The Groningen Radiotherapy-Induced Xerostomia questionnaire (GRIX).(T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).)
- Patient-Reported Outcome of xerostomia: The European organization for research and treatment of cancer quality of life questionnaire, head and neck-35 (EORTC QLQ-H&N35).(T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).)
- Immune response(T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).)
- Patient Reported Outcome: Goal Attainment Scale (GAS)(T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).)
Investigators
Christian von Buchwald
MD, DMSc, professor
Rigshospitalet, Denmark