Rationale
for the study: Oral mucositis is one of the most common
side effects in cancer treatment. Severe mucositis may lead to non-compliance
to treatment and complications that could add substantially to the cost of
care. Oral cryotherapy is effective for the prevention of oral mucositis in
adults receiving chemotherapy for solid cancer patients. But the effect of oral
cryotherapy in patient receiving Chemoradiation for the treatment of head and
neck cancer is still unknown. Aim:To assess the effect of oral-cryotherapy in prevention
of oral-mucositis in head and neck cancer patients receiving
Chemo-radiotherapy. Primary Objective: To assess the effect of addition of
prophylactic oral-cryotherpy in prevention of Gr-3 to Gr-4 oral Mucositis in
patients who receive chemo-radiotherapy for Head and Neck cancers. Secondary
Objective: To compare the QOL at the
end of CTRT between the 2 arms. To compare the patient
compliance to definitive treatment. To
assess additional cost incurred for management of Mucositis in both the
arms. Study
Type: Open label, parallel design, randomized
controlled study Study Methodolgy: Screening Visit: All
patients who are planned for Chemoradiotherapy in Tata Memorial Centre will be
screened for the study. If the inclusion/Exclusion criteria are fulfilled the
patient will be enrolled after well informed written consent and randomized. Randomization: Patients
will be randomly assigned to either of the 2 arms in 1:1 ratio by stratified randomization method where stratum would consist
of platinum based chemotherapy, taxane based chemotherapy and others. Study Intervention: Arm A- Intervention
arm(Definitive CT-RT + Oral-cryotherapy) Arm B- Control
arm(Definitive CT-RT) Arm A: All patients
randomized to Arm-A will be given oral-cryotherapy in the form of ice cubes/ice-chips/iced
water within 5 fractions of start of Radio-therapy till the end of Radiotherapy
or occurrence of Gr-3 or more mucositis whichever is earlier. Arm B: Patients will be
given Chemo-radiotherapy as per the treatment plan. Chemoradiation in both arms will be in accordance with the
institutional standards and standard guidelines like NCCN, ESMO. Patients may be advised sodium bicarbonate gargles as per the
treating physician. Cryotherapy administration: Patient has to take oral-cryotherapy 5-7 times a day by the
procedure as specified. Patients
will be provided with ice cubes/crushed ice or ice pop 30 min prior to the
start of radiotherapy. Once the ice melts, the liquid is rinsed around the
mouth to cool as large surface as possible of the oral mucosa. In addition, to
achieve cooling of the hindmost part of the throat, the liquid is gurgled for a
few seconds before it is swallowed or spat out. The procedure is repeated for
20-30minutes until start of radiotherapy and 10 minutes after the termination
of the Radiotherapy dose for the day. The same will be followed if patient has
chemotherapy dose also, except that the patient has to keep cold water in mouth
during chemotherapy. Other than chemo/radio-therapy dose of the day, the
patient has to repeat the same for 5-6 times per day During treatment
the patient may if necessary, rest for a maximum of 5 min. Food and drink
should, whenever possible, be consumed either before or after the cooling
session. Data Collection at baseline: All patients will undergo baseline
evaluations. Demographic details will be
recorded Baseline evaluations of height,
Weight, BMI Previous medical history will be
collected. Baseline Oral Mucositis grading
will be done as per NCI-CTCAE 5.0. Quality of Life will be measured
using QLQ-C30 and H&N-35 Study Visits: The follow-up visits will be as
per routine visits for patients under CT-RT. Patients will undergo laboratory
investigations as per their physician’s discretion. Compliance with trial intervention
will be evaluated. Oral Mucositis grading will be
done at each visit as per NCI-CTCAE 5.0. Weight loss if any will be recorded at
each visit and graded as per NCI-CTCAE 5.0. Any other adverse event or
Concomitant medications will be recorded at each visit. Quality of Life will be recorded
at baseline and first 3 months follow-up post CTRT Withdrawal Rules: The following are reasons
for removing a patient from the trial: Any condition that is a
contra-indication for oral intake Definitive treatment
with-held due to toxicity. Patient elects to
discontinue his/her participation in the trial by withdrawing consent Progressive disease
leading to discontinuation of definitive treatment. Gr-3 or Gr-4 mucositis
that would require management Primary
End-point: Occurrence of Gr-3 to Gr-5
Mucositis at any time point during CT-RT and post 3 months of its completion Secondary
End-points: To compare the compliance
to definitive treatment between two arms To compare the QOL at the
end of CTRT between the 2 arms To compare the cost
incurred for management of mucositis between 2 arms Sample Size Calculation: Assuming
grade 3 and above mucositis incidence of 67%, to decrease the mucositis by 10%
using a type 1 error of 5% and type of 20% , 1:1 allocation , we will require
128 patients.
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