Valcarcel, D., Sanz, M.A., Sureda, A., Sala, M., Munoz, L., Subira, M., et al. (2002). Mouth-washings with recombinant human granulocyte-macrophage colony stimulation factor (rhGM-CSF) do not improve Grade III-IV oropharyngeal mucositis (OM) in patients with hematological malignancies undergoing stem cell transplantation. Results of a randomized, double-blind, placebo-controlled study. Bone Marrow Transplantation, 29, 783-787.

Intervention Characteristics/Basic Study Process

Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) mouthwash

400 mcg dissolved in 20 mL NS; control received 200 mL saline only
Mouthwashings 3 times a day for 30 min without swallowing, over a period of 5 days after inclusion in protocol. Avoid other oral intake for 1 hour.

Also standard protocol of mouth care – toothbrushing after each meal and rinsing oral cavity with 0.9% saline or in cases of inflammation, 0.12% chlorhexidine four times daily

Only MM patients received IV GCSF 5 mcg/kg from day +7 to neutrophil recovery.

Sample Characteristics

The study was comprised of 41 patients (tx grp = 18, 23 placebo), with an age range of 16–69 years and a median age of 44.

All patients developed OM grade III-IV after auto- or allo-SCT.

Setting

Oct 1998 – Mar 2001

Study Design

Prospective randomized, double-blind placebo-controlled study

Measurement Instruments/Methods

WHO toxicity score grading mucositis from 0-4, EVA scale (visual analog) scoring swallowing induced pain from 0-10 3x a day, sleep quality evaluations as good, intermediate, and poor, and food intake, none, liquids, soft, regular

Also, infections, days with fever, fungal and viral oral infections, and need for broad spectrum antibiotics, TPN, and opioids were documented.


P < 0.05 = significant
 

Results

No statistically significant differences in overall duration of mucositis or duration of maximum grade of OM. Mouth pain and sleep quality scores were similar.
More people in the rhGM-CSF group needed PCA morphine (50%, 8pts) versus the NS (10%, 2pts).
Also no significance in the use of TPN between the two groups.
 

Conclusions

Given cost, it appeared the results were not better than NS.

No benefit of GM-CSF mouthwash.
May actually show benefit of NS.

Limitations

Schering-Plough supplied the rhGM-CSF.
Small diverse study group – long duration for study – other potential factors possibly change over time.
Study needs to be larger.
Only trialed with stem cell transplant recipients.
Patients were also rinsing with 0.9 NS and chlorhexidine as part of everyday mouth care (unable to determine number).

Study was from 1998-2001.

Study focused only on prevention after dev grade 3 – 4 OM.