Comparison of effectiveness of atropine versus placebo applied below tongue in the management of excessive salivation in head and neck cancer.

Efficacy of sub-lingual atropine versus placebo in the management of sialorrhea in head and neck cancer- An open label, Randomized controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072793

Enrollment

Registered

2024-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C04- Malignant neoplasm of floor of mouth Health Condition 3: C10- Malignant neoplasm of oropharynx Health Condition 4: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx Health Condition 5: C06- Malignant neoplasm of other and unspecified parts of mouth Health Condition 6: C05- Malignant neoplasm of palate

Interventions

Intervention1: Drug - sub-lingual atropine: 1% Atropine eye drops applied sublingually- 2 drops in 10ml water used thrice daily for 3 days. Control Intervention1: Placebo- 0.9% saline drops: 0.9% sali

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients diagnosed with head and neck cancer with sialorrhea, with a VAS score of more than or equal to 30%. 2. All patients aged more than 18 years. 3. All patients with ECOG performance status 0 to 3. 4. All patients who can understand Hindi/English.

Exclusion criteria

Exclusion criteria: 1. Age below 18 years. 2. All the patients on End of life care/ terminally ill patients with ECOG performance status of 4. 3. Presence of other causes of sialorrhea like parkinsonism, amyotropic lateral sclerosis, drug induced sialorrhea. 4. Patients not consenting for the study. 5. Patients with contraindication to use of atropine like coronary heart disease, acute angle glaucoma, obstructive diseases. 6. Patients unable to read and write Hindi/English. 7. Patients with no mouth opening/ absolute trismus. 8. Patients with oro-cutaneous and pharyngo-cutaneaous fistula.

Design outcomes

Primary

Measure	Time frame
To assess the effect of sub-lingual atropine versus placebo in the management of sialorrhea in patients with head and neck cancers using Visual analogue scale.Timepoint: To assess the effect of sub-lingual atropine versus placebo in the management of sialorrhea in patients with head and neck cancers using Visual analogue scale thrice- pre-intervention/baseline, day 3 and day 7 post intervention.	—

Secondary

Measure	Time frame
To assess the quality of life associated with sialorrhea in terms of choking, interference with social activities, interference with daily activities & global discomfort due to drooling in head & neck cancer pre & post intervention.Timepoint: Assessed using patient administered 4 point score thrice- pre-intervention, post-intervention day 3 & 7. [0-never, 1-sometimes, 2-often, 3-always];To assess the various factors associated with sialorrheaTimepoint: Assessed pre intervention/ baseline. 1. Mode of nutrition- oral feeds/ RT feeding/ Feeding procedures. 2. Dysphagia based on Modified Takita scoring. 3. Oral mucositis based on WHO grading. 4. Mouth opening measured with callipers & graded as per Thomas classification;To monitor the side-effects of sub-lingual atropine in the management of cancer associated sialorrhea.Timepoint: Patient reported symptoms on day 3 and 7 post intervention.	—

Measure

Time frame

To assess the quality of life associated with sialorrhea in terms of choking, interference with social activities, interference with daily activities & global discomfort due to drooling in head & neck cancer pre & post intervention.Timepoint: Assessed using patient administered 4 point score thrice- pre-intervention, post-intervention day 3 & 7. [0-never, 1-sometimes, 2-often, 3-always];To assess the various factors associated with sialorrheaTimepoint: Assessed pre intervention/ baseline. 1. Mode of nutrition- oral feeds/ RT feeding/ Feeding procedures. 2. Dysphagia based on Modified Takita scoring. 3. Oral mucositis based on WHO grading. 4. Mouth opening measured with callipers & graded as per Thomas classification;To monitor the side-effects of sub-lingual atropine in the management of cancer associated sialorrhea.Timepoint: Patient reported symptoms on day 3 and 7 post intervention.

—

Countries

India

Contacts

Public ContactDr Adithya Krishnan S

All India Institute of Medical Sciences, New Delhi

dr.shwetabhopale06@gmail.com8111938856

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026