Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C130- Malignant neoplasm of postcricoidregion Health Condition 3: C131- Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect Health Condition 4: C132- Malignant neoplasm of posterior wall of hypopharynx Health Condition 5: C138- Malignant neoplasm of overlappingsites of hypopharynx Health Condition 6: C139- Malignant neoplasm of hypopharynx,unspecified Health Condition 7: C12- Malignant neoplasm of pyrif
Conditions
Interventions
Intervention1: Transcutaneous Electrical Nerve Stimulation (TENS): Head and neck cancer patients on Parotid sparing VMAT receiving TENS daily during the course of RT.
Patients who are receiving TENS w
Sponsors
IMRF FUND, JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years of age 2. Patients with ECOG performance status 0 - 2 3. Patients of squamous cell carcinoma of head and neck can- cer planned for Radical RT with or without concurrent chem- otherapy using parotid sparing VMAT
Exclusion criteria
Exclusion criteria: 1. Patients with previous history of radiotherapy to head and neck 2. Patients with carcinoma of the head and neck in whom the salivary glands are involved by the disease 3. Pre-existing salivary gland disease 4. Patients with contraindications to pilocarpine or TENS were excluded. Contraindications to pilocarpine: - clinically important uncontrolled cardiac, renal, and pulmonary disease - ocular disease -Concurrent use of tricyclic antidepressants, antihistamines with anticholinergic effects, betablockers, pilocarpine eye preparations Contraindications to TENS: -Cardiac diseases -people with pacemaker or any electrical or metal implant -epilepsy, mental disorders -Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the difference in salivary flow rate between Transcutaneous Electrical Nerve Stimulation (TENS) and Pilocarpine in patients who are receiving parotid sparing Volumetric Modulated Arc Therapy (VMAT) in Head and Neck Cancer patients by sialometryTimepoint: At baseline, 3rd week, 6thweek during the course of radiation therapy, 6 weeks and 6 months post completion of radiation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether Transcutaneous Electri-cal Nerve Stimulation (TENS) would reduce the overall radiation-induced xerostomia burden compared with oral pilocarpine measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS)Timepoint: At baseline and at 6 months post completion of radiation therapy;Incidence of adverse events of pilocarpine and Transcutaneous Electrical Nerve Stimulation (TENS) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteriaTimepoint: At 3rd week, 6th week during the course of radiation therapy, 6 weeks and 6 months post completion of radia-tion therapy.;Relative change in excretion fraction by salivary scintigraphyTimepoint: At baseline and at 3, 6 months post completion of radiation therapy;Secretion velocity by salivary scintigraphyTimepoint: At baseline and at 3, 6 months post completion of radiation therapy.;Ophthalmic examination with measurement of Tear film, Intraocular Pressure (IOP), Anteri-or chamber depth, Pupil size, Refractive errorsTimepoint: At baseline and at 6 months post completion of radiation therapy. | — |
Countries
India
Contacts
Public ContactDr. Gunaseelan K
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed