The effects of Plantago Major on prevention of radiation induced acute mucositis

The effects of Plantago Major compared to placebo on prevention of radiation induced acute mucositis in head and neck cancer patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190312043027N1

Enrollment

Registered

2019-08-14

Start date

2018-10-22

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Radiation-induced mucositis in head and neck cancer. Oral mucositis (ulcerative)

Interventions

Intervention 1: Intervention group: Plantago syrup, three times per day,after each meal, each serving 7.5 cc, for 7 weeks. Intervention 2: Control group: Placebo syrup, three times per day, after each

Eligibility

Sex/Gender

All

Age

17 Years to 75 Years

Inclusion criteria

Inclusion criteria: Candidate for radiotherapy for head & neck cancer Patients with 17-65 years old Life expectancy over 1 year Good performance status in Eastern Cooperative Oncology Group (ECOG) questionnaire At least 4 areas in radiotherapy (RT) ?elds

Exclusion criteria

Exclusion criteria: Using alcohol Use of drugs a?ecting salivary gland secretions,such as antidepressants, Opiates, anti-hypertensives, anti-histamines. Use of mouthwash solutions Smoking History of mouth and oropharynx radiation therapy and chemotherapy in the last six months. History of connective tissue diseases affecting salivary glands such as Sjugren syndrome , Rheumatoid arthritis and Lupus and immunodeficiency diseases Grade 3-4 mucositis Candidiasis, oral herpes Hospitalization or need to Total Parental Nutrition ( TPN) Dissatisfaction to continue participating in the study Treatment failed Diabetes

Design outcomes

Primary

Measure	Time frame
Mucositis. Timepoint: Baseline of radiation therapy; every week after initiation of radiation therapy for 5 weeks and two weeks after intervention terminated. Method of measurement: Examination of oral cavity.;Pain. Timepoint: At the baseline and every week from first to seventh. Method of measurement: Visual analogue scale of pain.;Quality of life. Timepoint: At the baseline and every week from first to seventh. Method of measurement: EORTC questionnaire.	—

Measure

Time frame

Mucositis. Timepoint: Baseline of radiation therapy; every week after initiation of radiation therapy for 5 weeks and two weeks after intervention terminated. Method of measurement: Examination of oral cavity.;Pain. Timepoint: At the baseline and every week from first to seventh. Method of measurement: Visual analogue scale of pain.;Quality of life. Timepoint: At the baseline and every week from first to seventh. Method of measurement: EORTC questionnaire.

—

Secondary

Measure	Time frame
Side e?ects. Timepoint: Every week from first to seventh. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamreza Mohammadsoltani

Arak University of Medical Sciences

rezamohammadsoltani@yahoo.com+98 31 3362 4574

Outcome results

None listed

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