ONC: Chemotherapy (2006)
To evaluate the effect of curative chemotherapy on oral status and how the chemotherapy-induced mucositis impacts lifestyle.
- Be 17 years or older
- Planned stomatotoxic chemotherapy that could result in mucositis (5FU, ARA-C, Adriamycin and VP-16)
- Oncology patients on the oncology floors or in the outpatient department of a public hospital in Hong Kong
- Signed informed consent
Recruitment After ethics approval by the Faculty of Medicine of the Chinese University of Hong Kong, patients were enrolled prior to chemotherapy in the outpatient oncology department of while on the oncology floor of a hospital in Hong Kong.
Design Patients were assessed for mucositis and oral symptoms on day 1 of chemotherapy and then on the following day 8 and day 15/16 to assess for changes in oral mucosa as related to stomatoxic chemotherapy regimens.
Statistical Analysis
Statisical analysis was completed with SPSS version 10.
ANOVA was used to detect differences in patients mucositis scores and symptoms. If differences were found, then post hoc tests were applied.
Pearson correlation coefficients were completed for continuous data.
Spearman's rank correlation coefficient was used for categorical data.
Kruskal-Wallis and Mann-Whitney tests compared differences in demographics and treatment/illness data.
Timing of Measurements
At baseline:
- demographics (age, gender)
- stage of disease
- type of chemotherapy
- dietary intake including type of food/drink consumed, frequency of food/drink during treatment, tolerance of hot/spicy foods, alcohol consumption
- BMI
- Tobacco use
- Analgesic use
- Chinese herbal use
- Karnofsky performance status
Mucositis score (condition of oral mucosa only)
- collected on day 1 chemotherapy, day 8 and day 15 or 16 (day 8 and 16 in patients homes)
- measured with the World Health Organization grading scale for mucositis
| grade 0 | no mucositis |
| grade 1 | erythema, soreness |
| grade 2 | erythema and ulcers, still able to eat solids |
| grade 3 | ulcers, only able to take liquids |
| grade 4 | not able to eat or drink |
Severity of mucositis
- collected by research nurse
- collected on day 1 chemotherapy, day 8 and day 15 or 16 (day 8 and 16 in patients homes)
- scale:
grade 1 erythema grade 2 small isolated ulcerations grade 3 ulceration over 25% mouth grade 4 bleeding ulcers in mouth
Mucositis scale and severity of mucositis scores were totaled to give a range of 0 to 8.
Visual analog scales (VAS)
- completed by patients
- collected on day 1 chemotherapy, day 8 and day 15 or 16 (day 8 and 16 in patients homes)
- rated six symptoms associated with mucositis (dryness, oral discomfort, inability to chew, dysphagia, difficulty speaking and mouth pain)
- total scores from 0 to 600
Dependent Variables
- Mucositis score and severity of mucositis (see above)
- VAS for oral symptoms (see above)
Independent Variables
- chemotherapy treatment
- tolerance to hot foods
Initial N: 104 patients (55 male, 39 female)
Attrition (final N): 94 patients (reasons for drop-out include death, loss to follow-up, and patient relocation to mainland China).
Age: 17-71 years, mean 48.19±11.98
Ethnicity: Chinese only
Cancer sites:
- colorectal - 36
- head and neck - 19
- liver - 8
- breast - 4
- leukemia- 4
- gynecologic - 3
- lung - 3
- stomach - 2
- other - 15
Metastasis - 31/94 had metastasis
Anthropometrics not provided
Location: Public hospital in Hong Kong
|
Variables |
Baseline |
Day 8 |
Day 16 |
ANOVA |
|
Total mucositis score (0-8) |
0.32±0.90 |
1.78±1.74 |
1.36±1.81 |
F=23, P<0.001 |
|
Total symptom score using VAS (0-600) |
86.38±107.8 |
183±144 |
140.5±151.5 |
F=11.95, P<0.001 |
Other Findings
A positive correlation was found between the patient's total symptom score and eating spicy foods on day 1 (r=0.305, P<0.01).
When the patients were subdivided into 3 groups based on cancer site, the GI group (n=46) has a positive correlation between the total symptom score and patient's preference for spicy foods on day 1 (r=0.341, P<0.05). On day 16, a positive correlation was found in patients of all other cancer sites (n=29) for eating spicy foods and the total mucositis scores (r=0.458, P<0.05) and for spicy foods and total symptom score (r=0.536, P<0.01).
Mucositis scores on day 1 were higher for patients who had enjoyed spicy foods in the past (U=557, P<0.001). Oral symptoms scores on day 1 were also higher in patients who did not tolerate spicy foods (H=4.2, P<0.05).
The authors discussed the limitations in the study including lack of patient controls, a small and nonrandom sampling of patients, and mixture of patients in terms of cancer sites as well as the homogeneity of the study population (all Chinese patients).
The authors also reported that patients with mucositis report sensitivity fo spicy foods.
The authors suspect that the correlation among spicy good and oral symptoms on day is attributed to a pre-existing poor oral state and prior exposure to irritants (patients who ate spicy foods regularly) causing increased sensitivity and discomfort. As a result, the authors suggest that education prior to cancer treatment should include avoidance of spicy foods.
The symptoms score for mucositis and oral symptoms on day 16 was higher for spicy foods then hot foods.
| Government: | Health Services Research Fund (Hong Kong) |
Limited research exists to evaluate the effect food acidity/spicyness has on the oral mucosa as a result of cancer treatment. This study does present some evidence that spicy foods should be avoided prior to and during cancer treatment, but further research is need with larger, better designed studies.
Limitations:
- descriptions on dosing of chemotherapy unavailable
- multiple chemotherapy agents used in the study
- unsure if this was the first, or one of many, chemotherapy treatments for the patients- could affect mucosal lining if prior treatments
- did not exclude for prior XRT treatment or surgery to salivary glands/head and neck
- did not assess other medications that could affect oral mucosa and saliva production
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Quality Criteria Checklist: Primary Research
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| Relevance Questions | |||
| 1. | Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) | Yes | |
| 2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? | Yes | |
| 3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? | Yes | |
| 4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | N/A | |
| Validity Questions | |||
| 1. | Was the research question clearly stated? | Yes | |
| 1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | Yes | |
| 1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
| 1.3. | Were the target population and setting specified? | Yes | |
| 2. | Was the selection of study subjects/patients free from bias? | Yes | |
| 2.1. | Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? | ??? | |
| 2.2. | Were criteria applied equally to all study groups? | Yes | |
| 2.3. | Were health, demographics, and other characteristics of subjects described? | Yes | |
| 2.4. | Were the subjects/patients a representative sample of the relevant population? | Yes | |
| 3. | Were study groups comparable? | N/A | |
| 3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | N/A | |
| 3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | N/A | |
| 3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | N/A | |
| 3.4. | If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? | N/A | |
| 3.5. | If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) | N/A | |
| 3.6. | If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? | N/A | |
| 4. | Was method of handling withdrawals described? | Yes | |
| 4.1. | Were follow-up methods described and the same for all groups? | Yes | |
| 4.2. | Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) | Yes | |
| 4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
| 4.4. | Were reasons for withdrawals similar across groups? | N/A | |
| 4.5. | If diagnostic test, was decision to perform reference test not dependent on results of test under study? | N/A | |
| 5. | Was blinding used to prevent introduction of bias? | No | |
| 5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | N/A | |
| 5.2. | Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) | No | |
| 5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | N/A | |
| 5.4. | In case control study, was case definition explicit and case ascertainment not influenced by exposure status? | N/A | |
| 5.5. | In diagnostic study, were test results blinded to patient history and other test results? | N/A | |
| 6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | ??? | |
| 6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | N/A | |
| 6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | Yes | |
| 6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | Yes | |
| 6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | ??? | |
| 6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | ??? | |
| 6.6. | Were extra or unplanned treatments described? | N/A | |
| 6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | N/A | |
| 6.8. | In diagnostic study, were details of test administration and replication sufficient? | N/A | |
| 7. | Were outcomes clearly defined and the measurements valid and reliable? | Yes | |
| 7.1. | Were primary and secondary endpoints described and relevant to the question? | Yes | |
| 7.2. | Were nutrition measures appropriate to question and outcomes of concern? | Yes | |
| 7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | Yes | |
| 7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | Yes | |
| 7.5. | Was the measurement of effect at an appropriate level of precision? | Yes | |
| 7.6. | Were other factors accounted for (measured) that could affect outcomes? | No | |
| 7.7. | Were the measurements conducted consistently across groups? | Yes | |
| 8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | Yes | |
| 8.1. | Were statistical analyses adequately described and the results reported appropriately? | Yes | |
| 8.2. | Were correct statistical tests used and assumptions of test not violated? | Yes | |
| 8.3. | Were statistics reported with levels of significance and/or confidence intervals? | Yes | |
| 8.4. | Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? | No | |
| 8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | Yes | |
| 8.6. | Was clinical significance as well as statistical significance reported? | No | |
| 8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
| 9. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
| 9.1. | Is there a discussion of findings? | Yes | |
| 9.2. | Are biases and study limitations identified and discussed? | Yes | |
| 10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
| 10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
| 10.2. | Was the study free from apparent conflict of interest? | Yes | |