Effect of spaghula husk mucilage on prevention of chemotherapy-induced mucositis

Phase 3

• Conditions: Adriamycin induced oral mucositis.; Oral mucositis (ulcerative) due to antineoplastic therapy; K12.31

• Registration Number: IRCT20180923041093N1
• Lead Sponsor: Vice chancellor for research, Kerman university of medical sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Breast cancer
Candidate for adriamycin
mucositis in screening course
Remaining two courses of adriamycin with two weeks interval
Age between 17 and 65 years
Life expectancy for more than a year based on physician or team estimates
Physical and mental ability to cooperate in filling in the questionnaire
The desire to participate in the study

Exclusion Criteria

Use alcohol
Use of drugs that affect salivary glands such as antipsychotics, opioids, antihypertensives, antihistamine, diuretics
Use of mouthwashes and artificial saliva and cigarettes
Receiving Early Radiation in mouth or oropharynx
The history of connective tissue diseases, such as Sjogren, rheumatoid arthritis, lupus
Liver and kidney disease
Major Depression
Diseases that affect salivary glands such as diabetes
Diseases that induce dehydration such as chronic diarrhea
Diseases of the immune system
Recurrent aphthous stomatitis
Receiving Lithium or Levothyroxine for interference with spaghula

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of oral mucositis according to WHO scale. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: WHO scale for oral mucositis.;Degree of pain due to oral mucositis. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: Visual Analogue Scale.;Quality of life. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: OHIP-14 questionnaire.;Xerostomia. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: LENT-SOMA scale.