Comparison two methods of treatment of mouth ulcer in childhood cancer patients study design: Randomized parallel trial

Randomized controlled trial of oral GCSF versus oral aid for treating oral mucositis in patients with childhood cancer receiving chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17793029

Enrollment

Registered

2015-10-07

Start date

2013-04-01

Completion date

Unknown

Last updated

2017-05-22

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

Conditions

Oral mucositis Oral Health Oral mucositis

Interventions

Medication (routinely used in the pediatric Oncology ward in HUSM) will be given three times daily (morning, evening, and night) until the oral mucositis resolved. Block randomization will be used for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 3-12 years 2. Have oral mucositis 3. On chemotherapy treatment

Exclusion criteria

Exclusion criteria: 1. Other causes of oral ulcer such as trauma and CT disease 2. Cancer patient who is not under chemotherapy

Design outcomes

Primary

Measure	Time frame
Primary outcomes as of 18/04/2017: 1. Time to healing of oral mucositis is measured using WHO oral toxicity scale at baseline and daily until oral mucositis resolved at 24, 48, 72, 96, 120, 144, and 168 hours 2. Improvement in the absolute neutrophil count is measured using results of absolute neutrophil count in full blood count at baseline and one week Original primary outcome: Healing of the oral mucositis between oral GCSF and oral aid, measured at baseline, day 3 and day 7.	—

Measure

Time frame

Primary outcomes as of 18/04/2017: 1. Time to healing of oral mucositis is measured using WHO oral toxicity scale at baseline and daily until oral mucositis resolved at 24, 48, 72, 96, 120, 144, and 168 hours 2. Improvement in the absolute neutrophil count is measured using results of absolute neutrophil count in full blood count at baseline and one week Original primary outcome: Healing of the oral mucositis between oral GCSF and oral aid, measured at baseline, day 3 and day 7.

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Secondary

Measure	Time frame
Secondary outcome as of 18/04/2017: 1. Relief of oral pain and dysphagia is measured using WHO oral toxicity scale at baseline, 3 and 7 days Original secondary outcomes: 1. Relief the pain of oral mucositis also measured at baseline, measured at baseline, day 3 and day 7. Who oral toxicity scale will be used to assess the severity the oral toxicity are ranked on a scale of 1 to 4, with 1 being minor soreness and painless, 2 is painful erythema, edema, or ulcers but able to eat ,3 is painful erythema, edema, or ulcers but unable eat,and 4 If there is sever pain and requirement for parenteral or enteral support 2. Improvement in absolute neutrophile count (ANC) measured pre (at baseline) and post (on day 7).	—

Measure

Time frame

Secondary outcome as of 18/04/2017: 1. Relief of oral pain and dysphagia is measured using WHO oral toxicity scale at baseline, 3 and 7 days Original secondary outcomes: 1. Relief the pain of oral mucositis also measured at baseline, measured at baseline, day 3 and day 7. Who oral toxicity scale will be used to assess the severity the oral toxicity are ranked on a scale of 1 to 4, with 1 being minor soreness and painless, 2 is painful erythema, edema, or ulcers but able to eat ,3 is painful erythema, edema, or ulcers but unable eat,and 4 If there is sever pain and requirement for parenteral or enteral support 2. Improvement in absolute neutrophile count (ANC) measured pre (at baseline) and post (on day 7).

—

Countries

Malaysia

Outcome results

None listed

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