This study is a phase I safety and feasibility study to treat head and neck cancer patients with autologous salivary gland stem cell transplantation after postoperative (chemo)radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy
UMCG
Groningen, Netherlands
RECRUITINGSafety: adverse events
The number of adverse events (AE), serious adverse events (SAE) or suspected unexpected adverse reactions (SUSAR) after autologous salivary stem cell transplantation. All possible adverse events will be scored according to the definitions of the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0).
Time frame: Data for assessing safety will be recorded from day 1 to 365.
Feasibility: salivary flow rate
The salivary flow rate of the remaining submandibular gland will be recorded.
Time frame: Data for assessing feasibility will be recorded 6 and 12 months after autologous stem cell transplantation to assess if salivary flow will be increased compared to salivary flow before transplantation.
Salivary flow recovery
Unstimulated whole saliva, paraffin stimulated whole saliva and 5% citric acid stimulated parotid and submandibular/sublingual saliva measurements.
Time frame: Saliva measurements at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation
Impact of transplantation
Patient-rated outcome measures including various side effects related to the postoperative (chemo)radiation and Quality of Life (QoL) using internationally validated questionnaires.
Time frame: Patient-rated outcome measures at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation
Locoregional control
Locoregional control is defined as the number of patients with recurrent disease within or adjacent to the primary tumor site and regional lymph nodes after postoperative (chemo)radiation, assessed by pathology and/or oncologic imaging (CT, MRI or PET).
Time frame: 5 years after postoperative (chemo)radiation
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Overall survival and disease-free survival
Time frame: 5 years after postoperative (chemo)radiation
Rate of water diffusion in remaining submandibular gland
The rate of water diffusion in remaining submandibular gland derived from DWI/DTI-MRI.
Time frame: 6 and 12 months after postoperative (chemo)radiation
Amount of PSMA
The amount of prostate specific membrane antigen (PSMA) in the remaining submandibular gland derived from PET-CT
Time frame: 6 and 12 months after autologous stem cell transplantation