A Randomized Double-Blind Placebo-Controlled Phase IIB Trial of Curcumin in Oral Leukoplakia.

Oral leukoplakia is a potentially malignant lesion of the oral cavity, for which no effective treatment is available. We investigated the effectiveness of curcumin, a potent inhibitor of NF-κB/COX-2, molecules perturbed in oral carcinogenesis, to treat leukoplakia. Subjects with oral leukoplakia (n = 223) were randomized (1:1 ratio) to receive orally, either 3.6 g/day of curcumin (n = 111) or placebo (n = 112), for 6 months. The primary endpoint was clinical response obtained by bi-dimensional measurement of leukoplakia size at recruitment and 6 months. Histologic response, combined clinical and histologic response, durability and effect of long-term therapy for an additional six months in partial responders, safety and compliance were the secondary endpoints. Clinical response was observed in 75 (67.5%) subjects [95% confidence interval (CI), 58.4-75.6] in the curcumin and 62 (55.3%; 95% CI, 46.1-64.2) in placebo arm (P = 0.03). This response was durable, with 16 of the 18 (88.9%; 95% CI, 67.2-96.9) subjects with complete response in curcumin and 7 of 8 subjects (87.5%) in placebo arm, demonstrating no relapse after 6 months follow-up. Difference in histologic response between curcumin and placebo was not significant (HR, 0.88, 95% CI, 0.45-1.71; P = 0.71). Combined clinical and histologic response assessment indicated a significantly better response with curcumin (HR, 0.50; 95% CI, 0.27-0.92; P = 0.02). Continued therapy, in subjects with partial response at 6 months, did not yield additional benefit. The treatment did not raise any safety concerns. Treatment of oral leukoplakia with curcumin (3.6 g for six months), thus was well tolerated and demonstrated significant and durable clinical response for 6 months. Cancer Prev Res; 9(8); 683-91. ©2016 AACR.

Early effect of surgery on quality of life in women with operable breast cancer.

BACKGROUND: Quality of life (QOL) after a diagnosis of breast cancer varies considerably across individuals. The treatment modality of the patients significantly contributes to their QOL. The present study reports the initial findings on the early effects of surgery in patients with breast cancer. METHODS: Two hundred and fifty-one women with breast cancer undergoing surgery were interviewed prior to and after the surgery using the Functional Assessment of Cancer Therapy for Breast (FACT-B). Trial Outcome Index (TOI) was calculated besides total and subscale scores. The results were analyzed using paired t-test and two-sample paired Wilcoxon signed rank test. Multivariate analysis was carried out using repeated measures general liner model with 2-way interactions. RESULTS: Significant reduction in physical well-being (P = 0.001), functional well-being (P = 0.00) and the breast-specific subscale (P = 0.000) was observed after surgery. No significant change was observed in social or emotional well-being. Total FACT scores and TOI too showed significant declines (P = 0.000; and P = 0.000 respectively) on univariate analysis. Multivariate analysis, however, showed no difference in QOL after surgery, but QOL was significantly poor among women undergoing mastectomy. CONCLUSIONS: Results of the present study indicate no significant change in overall QOL immediately after the surgery, probably reflecting strong family and social support for these women. QOL was significantly better among women undergoing breast conservation compared with mastectomy.

Factors influencing distress in Indian cancer patients.

BACKGROUND: The current study set out to identify distress in cancer patients undergoing curative treatment within India. PATIENTS AND METHODS: This study was carried out to measure distress and contributory factors in 103 cancer patients undergoing treatment with curative intent. The patients were interviewed using the Distress Inventory for Cancer (DI-C). The data on social, demographic, clinical, treatment, and follow-up details was collected from case records. RESULTS AND CONCLUSION: The distress score for individual respondents ranged from 34 to 90 (mean 62.3). Patients with lower income, those who were single/widowed, or divorced, those living between 150 and 350 km (3-6 h commuting distance) from the cancer centre, presence of pain and patients with advanced tumours at presentation showed higher distress. A higher distress score correlated significantly with patients being lost to follow-up.

Quality of life determinants in women with breast cancer undergoing treatment with curative intent.

BACKGROUND: The diagnosis of breast cancer and its subsequent treatment has significant impact on the woman's physical functioning, mental health and her well-being, and thereby causes substantial disruption to quality of life (QOL). Factors like patient education, spousal support and employment status, financial stability etc., have been found to influence QOL in the breast cancer patient. The present study attempts to identify the determinants of QOL in a cohort of Indian breast cancer patients. PATIENTS AND METHODS: Functional Assessment of Cancer Therapy-Breast (FACT-B) Version 4 Malayalam was used to assess quality of life in 502 breast cancer patients undergoing treatment with curative intent. The data on social, demographic, disease, treatment, and follow-up were collected from case records. Data was analysed using Analysis of Variance (ANOVA) and multinomial logistic regression. RESULTS: The mean age of the patients was 47.7 years with 44.6% of the women being pre-menopausal. The FACT-B mean score was 90.6 (Standard Deviation [SD] = 18.4). The mean scores of the subscales were - Physical well-being 19.6 (SD = 4.7), Social well-being 19.9 (SD = 5.3), Emotional well-being 14 (SD = 4.9), Functional well-being 13.0 (SD = 5.7), and the Breast subscale 23.8 (SD = 4.4). Younger women (< 45 years), women having unmarried children, nodal and/or metastatic disease, and those currently undergoing active treatment showed significantly poorer QOL scores in the univariate analysis. However multivariate analysis indicated that the religion, stage, pain, spouse education, nodal status, and distance travelled to reach the treatment centre as indicative of patient QOL. CONCLUSION: QOL derangements are common in breast cancer patients necessitating the provisions for patient access to psychosocial services. However, because of the huge patient load, a screening process to identify those meriting intervention over the general population would be a viable solution.

Reliability and validity of the Malayalam hospital anxiety and depression scale (HADS) in cancer patients.

BACKGROUND & OBJECTIVE: The hospital anxiety and depression scale (HADS) has been widely used on cancer patients as an indicator of psychological morbidity. Though the scale has been used in India, no reports are available on translation of HADS in any Indian language and testing the reliability. The present study describes the translation process of HADS into Malayalam and testing its reliability and validity on psychological morbidity in cancer patients. METHODS: The English version of the HADS was translated into Malayalam and was used in this study. The questionnaire was administered to 240 cancer patients and statistical analysis was carried out using Chronbach's alpha to test the internal consistency of the HADS scale while confirmatory factor analysis was carried out using principal axis factoring with equimax rotation and Kaiser Normalization to test its construct validity. RESULTS: The Cronbach's alpha was found to be 0.81 for the HADS anxiety subscale, 0.71 for the HADS depression subscale, and 0.85 for HADS tool. Confirmatory factor analysis (CFA) indicated two depression items (i.e., enjoyment and anhedonia) loading onto the anxiety subscale. Clinical caseness for anxiety was observed in 8 per cent, while 11 per cent of the patients had borderline mood disorder. Clinical caseness for depression was identified in 7.6 and 13 per cent of patients were found to have borderline mood disturbances. INTERPRETATION & CONCLUSION: This preliminary validation study of the Malayalam version of the HADS showed it as an acceptable, and reliable measure of psychological morbidity among cancer patients. The prevalence of anxiety and depression in Indian population was low and enjoyment and anhedonia might present as anxiety initially.

Reliability & validity of the Malayalam Functional Assessment of Cancer Therapy for Head & Neck Cancer.

BACKGROUND & OBJECTIVES: The need for quality over quantity in cancer survival is increasingly being recognised in the developing countries, and the efforts to monitor quality of life (QOL) are increasing. However, the non-availability of a valid and reliable tool in the local language is a common problem. Cross-culturally sensitive tools enable the researchers to compare different patient populations and identify cultural differences and variations. The present study was carried out to translate, validate and test for reliability a reliable QOL tool for the head and neck cancer patient population in a tertiary care hospital in south India. METHODS: The functional assessment of cancer therapy for head and neck cancer (FACT-H&N) was translated into the local language (Malayalam) and tested for reliability in 140 patients of head and neck cancer. RESULTS: The translated tool showed substantial psychometric sensitivity. The Cronbach's alpha for the total FACT-H&N was 0.94. The alpha scores for the five subscales ranged from 0.81-0.92. Significant correlations were observed amongst the total QOL and subscale scores and patient's demographic, disease and treatment variables. INTERPRETATION & CONCLUSION: The Malayalam translation of the FACT-H&N questionnaire was developed, tested and validated. It was found to satisfactorily measure QOL in head and neck cancer patients.

Identifying and predicting behaviour outcomes in cancer patients undergoing curative treatment.

A lot of emphasis is now being placed in early identification of 'distress', a state that lies between the feelings of sadness and apprehension, and clinically defined syndromes. It is assumed that an intervention at this stage will check the progression along the continuum in cancer patients. We have been working in global distress in cancer patients undergoing multimodality treatment with curative intent, for over 5 years. It all started with the generation of a hypothesis which led to the development of the 'Distress Inventory for Cancer', its refinement, and finally to modelling distress. This article gives a brief overview of our work on distress as conceptualised by the National Comprehensive Cancer Network in 1998, adopted and modified by us using informal patient interviews, expert Delphi exercise and structured patient interviews.

Oral cancer in southern India: the influence of smoking, drinking, paan-chewing and oral hygiene.

Between 1996 and 1999 we carried out a case-control study in 3 areas in Southern India (Bangalore, Madras and Trivandrum) including 591 incident cases of cancer of the oral cavity (282 women) and 582 hospital controls (290 women), frequency-matched with cases by age and gender. Odds ratios (ORs) and 95% confidence intervals (CIs) were obtained from unconditional multiple logistic regressions and adjusted for age, gender, center, education, chewing habit and (men only) smoking and drinking habits. Low educational attainment, occupation as a farmer or manual worker and various indicators of poor oral hygiene were associated with significantly increased risk. An OR of 2.5 (95% CI 1.4-4.4) was found in men for smoking > or = 20 bidi or equivalents versus 0/day. The OR for alcohol drinking was 2.2 (95% CI 1.4-3.3). The OR for paan chewing was more elevated among women (OR 42; 95% CI 24-76) than among men (OR 5.1; 95% CI 3.4-7.8). A similar OR was found among chewers of paan with (OR 6.1 in men and 46 in women) and without tobacco (OR 4.2 in men and 16.4 in women). Among men, 35% of oral cancer is attributable to the combination of smoking and alcohol drinking and 49% to pan-tobacco chewing. Among women, chewing and poor oral hygiene explained 95% of oral cancer.