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REVIEW ARTICLE
Year : 2020  |  Volume : 16  |  Issue : 6  |  Page : 1210-1214

Addressing and targeting earnest condition of advance breast cancer-related anorexia and cachexia through Rasayana therapy


1 Department of Clinical Research, Rasayani Biologics Pvt. Ltd., Pune, Maharashtra, India
2 Department of Oncology (Ayurveda), Rasayu Cancer Clinic, Pune, Maharashtra, India

Date of Submission22-Jan-2020
Date of Decision07-Apr-2020
Date of Acceptance22-Jun-2020
Date of Web Publication18-Dec-2020

Correspondence Address:
Yogesh Bendale
Department of Oncology (Ayurveda) Rasayu Cancer Clinic, B-1, Amrutkumbh Apts; Laxmi Park Society, Near Bhide hospital, Pune - 411030, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcrt.JCRT_96_20

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 > Abstract 


Anorexia and cachexia are major clinical problems seen in a large proportion of patients with advanced cancer. Weight loss has also been identified as an indicator of poor prognosis in cancer patients. Around 20% of patients with advanced cancer present mortality from the effects of malnutrition rather than from cancer itself. Early nutrition intervention has seen to improve outcomes in cancer patients such as weight gain, treatment tolerance, and improved quality of life (QoL). Effective therapies for addressing these threatening conditions are lacking. Pharmacotherapeutic agents such as corticosteroids, megestrol acetate, and cyproheptadine have several adverse reactions and also lack satisfactory results. Rasayana therapy is known to prevent loss of body mass and at the same time help to improve appetite and increase patient's QoL. The Rasayana compound used by us to prevent cachexia mainly includes swarna sindoor, Hirak bhasma, and suvarna bhasma. To evaluate benefits of Rasayana therapy on these variables, we maintain complete documentation of different clinical variables in all cancer patients. Here, in this observational study, we analyzed the data collected from a group of stage IV breast cancer patients (n = 30) receiving Rasayana therapy. Patients were followed at an interval of every 15 days from baseline for 3 months. Furthermore, at each visit, there weight was recorded on calibrated digital weight balance. QoL in these patients was recorded at quarterly interval using functional assessment of cancer therapies questionnaire. It was seen that in the duration of 3 months patients appetite increased significantly (P = 0.03). Significant weight gain was seen in patients (P = 0.04). Significant improvement was also seen in QoL especially related to QoL subdomains of physical wellbeing (P = 0.01), emotional wellbeing (P < 0.04), and functional wellbeing (P < 0.001). Rasayana therapy was seen to be well tolerated by all patients.

Keywords: Anorexia, cachexia, cancer, Rasayana


How to cite this article:
Kadam A, Bendale Y, Birari-Gawande P. Addressing and targeting earnest condition of advance breast cancer-related anorexia and cachexia through Rasayana therapy. J Can Res Ther 2020;16:1210-4

How to cite this URL:
Kadam A, Bendale Y, Birari-Gawande P. Addressing and targeting earnest condition of advance breast cancer-related anorexia and cachexia through Rasayana therapy. J Can Res Ther [serial online] 2020 [cited 2021 Nov 27];16:1210-4. Available from: https://www.cancerjournal.net/text.asp?2020/16/6/1210/303901




 > Introduction Top


Breast cancer is the most common cancer affecting women. Globally, about 1.4 million new cases are diagnosed each year.[1] Breast cancer has ranked number one cancer among Indian females with age adjusted rate as high as 25.8 per 100,000 women and mortality 12.7 per 100,000 women. The age adjusted incidence rate of carcinoma of the breast was found as high as 41 per 100,000 women for Delhi, followed by Chennai (37.9), Bengaluru (34.4), and Thiruvananthapuram district (33.7). A statistically significant increase in age-adjusted rate over time (1982–2014) in all the population-based cancer registry namely Bengaluru (annual percentage change [APC]: 2.84%), Barshi (1.87%), Bhopal (2.00%), Chennai (2.44%), Delhi (1.44%), and Mumbai (1.42%) was observed. Mortality-to-incidence ratio was found to be as high as 66 in rural registries whereas as low as 8 in urban registries.[2],[3] The youngest age group consisting of 15–34 years had an APC of 4.24%, 1.60%, and 0.80% in Nagpur, Mumbai, and Chennai, respectively. For 35–44 years of age group, the APC ranged from 0.37% to 2.97% in these registries. However, the oldest age group comprising of patients >64 years, the APC ranged from 0.53% to 2.64%.[4] Studies suggest that the disease peaks at 40–50 years in Indian women.[5] Cancer projections are useful especially in a developing country like India, where there is an urgent need to plan and prioritize health care services including both diagnostic and treatment facilities. Breast cancer projection for India during time periods 2020 suggests the number to go as high as 17,97,900 with its approximately relative percentage remaining same 10% among all the cancers.[6]

The diagnosis of breast cancer carries a negative stigma, regardless of the disease prognosis. Despite the success of effective anticancer treatment, they can live with other problems related to: psychosocial impact of treatment; chances of relapse; association with other comorbidities such as cardiovascular disease, diabetes, and osteoporosis.[7] The most common forms of treatments include surgery, chemotherapy, radiation therapy, and hormonal therapy. More than one way can be used in a complementary manner. Despite the frequent success of the therapy, many adverse events (AE) are observed, leading to the decline functional.[8] AEs caused by chemotherapy drugs are related to their lack of specificity for tumor cells and cytotoxic effects on normal cells. The most common AEs experienced are pain, lymphedema, peripheral neuropathy, fertility issues, and premature menopause and cardiotoxicity. These events predominate in cells that are in constant division, such as the hematopoietic tissue, the germinal tissue of hair follicles, and gastrointestinal coating. Despite increase survival, chemotherapy, and hormonal therapies influence negatively the quality of life (QoL) due to these AEs.[9]

A large number of patients with advanced stage cancer undergo a typical wasting syndrome characterized by severe anorexia, loss of weight, asthenia, and a poor prognosis, referred to as the cancer anorexia/cachexia syndrome. It was seen in a study conducted on cancer patients taking palliative care service; anorexia/cachexia and asthenia were more common than pain. These symptoms cluster were found to be within the top five most troubling and bothersome symptoms for cancer patients approaching the end of life. It is currently understood that Patients who exhibit such signs and symptoms have a short survival, respond poorly to chemotherapy agents, and also suffer from increased toxicity from these agents. Besides this patients suffering from this syndrome are associated with symptoms such as weakness, fatigue, and poor QoL.[10] The prevalence of cachexia increases from 50% to more than 80% before death and in more than 20% of patients, cachexia is the main cause of death.[11] In healthy adults, the 95% confidence intervals for change in body weight is approximately ±2% in 1 month, ±3.5% in 3 months, and ±5% within a 6-month follow-up.[11],[12] Any weight loss of more than 5% of premorbid weight observed within a 6-month period can be called as cachexia. Often a weight loss of 10% or more is considered as a starting criterion for the anorexia-cachexia syndrome in obese patients.

The cancer-related anorexia/cachexia syndrome (CACS) is characterized by anorexia and a loss of body weight associated with reduced muscle mass and adipose tissue. In addition to a variable contribution from decreased energy intake, resting energy expenditure can be elevated in CACS in association with increases in both muscle protein breakdown and lipolysis, changes that appear to be due in part to an inflammatory response with the elaboration of cytokines, including tumor necrosis factor-alpha, interleukin (IL)-6, and IL-1 beta. Tumor-elaborated factors may play an important role. Unlike starvation, weight loss in cancer arises both from loss of muscle and fat. Patients who exhibit such signs and symptoms generally have a short survival time, respond poorly to chemotherapy agents, and suffer increased toxicity from these agents. In addition, cancer anorexia/cachexia often is associated with weakness, fatigue, and a poor QoL. This symptom of anorexia not only affects the patient but also frequently has a negative impact on family members, in part because the patient is no longer able to participate fully in eating as a social activity. These devastating syndrome declines QoL, lower tolerance to chemotherapy, reduced physical functioning, and worse survival. Although the great need, there are few therapeutic options and no standard of care for the treatment of cancer anorexia/cachexia, other than treating the underlying disease. Thus, these symptoms must be given considerable perceptiveness to encounter cancer.[13],[14]

The National Comprehensive Cancer Network (NCCN) has published Guidelines for Supportive and Palliative Care Symptom Management for anorexia-cachexia.[15],[16] When life expectancy is years to months, the NCCN guidelines recommendations include assessments, medications, and nonpharmacologic approaches. Pharmacotherapeutic agents used to treat these conditions are corticosteroids, megestrol acetate, cyproheptadine, hydrazine sulfate, and dronabinol. These therapies are found to be having limited therapeutic efficacy and at the same time are associated with adverse reactions. Ayurveda has mentioned various Rasayana compounds which have Brumhana and Dhatuvardhana (promotes growth of body tissues) properties. We are using these compounds in advanced stage cancer patients for treating anorexia, preventing weight loss, and improving QoL. All our patients taking treatment in our clinic undergo a regular documentation of changes in various clinical variables. By using these available clinical data, we planned this retrospective study with an aim to systematically evaluate the efficacy of Rasayana – in the management of patients with advanced breast cancer presenting with anorexia – cachexia.


 > Methods Top


Study population

As a part of a regular clinical practice, we maintain systematic clinical documentation of various variables in a structured case record form. These data are used to monitor the developments in patients and also to understand trends in patients. Patients are requested to give consent for use of their data for conducting clinical observational studies on the condition of maintaining confidentiality. In this study, we have used data pertaining to variables such as weight, appetite, and QoL from randomly selected 30, stage IV breast cancer patients who have voluntarily given consent to use their data for this observational retrospective study. The method of data collection was observational chart review in which data of eligible patients were collected from case record form. Only those stage IV breast cancer patients who are complaining anorexia (anorexia score ≤4 on a 10 point visual analog scale (VAS) where 0 represents no appetite and 10 represents very good appetite) and has lost more than 10% of body weight at baseline were considered eligible for including their data in the study. Data of patients taking chemotherapy/radiotherapy or any other palliative care therapy which is indicated to increase body weight or appetite were excluded from the study. However, patients who took chemotherapy/radiotherapy at least 1 month before starting Rasayana therapy were included in the study.

Study design

A retrospective, observational, within subject pre-postdesign was used. As a part of standard clinical practice, patients are expected to visit clinic for follow-up at a regular interval of 15 days. Hence, follow-up data pertaining to weight and appetite were collected at an interval of approximately 15 days (±3 days) from baseline till 3 months.

Study variables

Weight, appetite, and QoL were the selected variables. Weight was recorded with light clothing's, without shoes on a calibrated digital weight balance. Changes in appetite were recorded using a 10-point VAS where 0 represents no appetite and 10 represents very good appetite. QoL in these patients was recorded at a quarterly interval using functional assessment of cancer therapies (FACT-G) questionnaire.[17]

Treatment modalities

The main line of treatment was based on principles of Rasayana therapy. The prime formulations which were used in all the patients for increasing weight, appetite, and improving QoL were Suvarnasindoor, Hirak bhasma, and suvarnabhasma. Suvarnasindoor was administered at the dosage of 30 mg at night, Hirak Bhasma was administered at the dosage of 2.5 mg twice daily and Suvarnabhasma was administered at the dosage of 30 mg at night daily. All the above compounds were administered with honey at empty stomach avoiding food intake 1 h before and after taking medicines. All the formulations used were obtained from good manufacturing practices certified company.

Statistical analysis

Statistical significance of mean changes from baseline to 3rd month was assessed using nonparametric Wilcoxon Signed-ranks test. Paired sample test was however used to check statistical significance of mean changes in QoL scores. Missing data were replaced considering Intent to treat analysis using last observation carried forward imputation technique. Statistical analyses were performed with SPSS software for Windows, version 20.0.


 > Results Top


Of the 30 patients, whose data were selected for study 26 patients showed follow-up for the entire 3 months [Table 1]. The mean age of the patients was 56 years (±3.5 years). There was significant increase in weight (P < 0.05) [Table 2], and appetite (P < 0.005) [Table 3] by the end of the 3rd month. The overall increase in mean weight was 1.8%. Besides this a significant increase in QoL scores of following FACT-G subscales [Table 4] was also seen physical wellbeing (<0.01), emotional wellbeing (<0.05), functional wellbeing (<0.001), and FACT-G total QoL score (P < 0.05).
Table 1: Number of patients at each follow-up visit

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Table 2: Changes in weight

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Table 3: Changes in appetite (Anorexia scale score)

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Table 4: Changes in quality of life scores

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 > Discussion Top


It was noticed that the main intentions of caregivers and patients to select adjuvant Ayurveda therapy in these patients with advanced cancer was to control symptoms such as anorexia, cachexia, and fatigue besides maintaining or improving the health-related QoL. Anorexia and cachexia are one of the most common symptoms in patients with advanced malignancies and are known to adversely affect patients performance status and QoL. It is now believed that cancer cachexia is a complicated term which describes marked weight loss in patients with cancer and most importantly which cannot be reversed by normal nutritional support.[18] Cancer anorexia cachexia usually gets worse over time as weight loss increases, which also leads to difficulties for patients with everyday activities.[19] The findings of this study clearly indicate that Rasayana therapy has played a very important role in increasing weight of patients. Although the weight gain was about 1.8% in 3 months, this counts a lot considering the above-mentioned fact that weight loss in cancer cachexia in advanced stage cannot be reversed by nutritional support and it gets worst over time.

It is seen that often family caregivers continue to try to help the patient by reminding and pleading with the patient to eat, as eating/feeding have great cultural meanings. The patient's inability to eat can lead to irritability and become a source of tension leading to family conflict and social isolation.[20],[21],[22] Rasayana therapy also showed a marked improvement in patient's appetite. Thus, it can be said that Rasayana therapy can play an important role in improving outcomes in patients of cancer cachexia anorexia.

Cancer cachexia affects multiple dimensions of health-related QoL, including physical, psychological, and social functioning.[23] Because of various aspects associated with the cancer and associated weight loss and anorexia patients' QoL seems to decrease in all dimensions. The findings of this study have shown that Rasayana therapy can play an important role in improving physical, functional, and emotional dimensions of patient's QoL. However, no significant improvement was seen in social dimension of patient's QoL.

Unfortunately, because of a lack of effective pharmacological therapies, practitioners may have the perception that cancer cachexia is an intractable, untreatable condition. As a result of this misconception, patients may not receive effective treatment.[24] Rasayana therapy with the compounds used in this study seems to provide an effective therapeutic option in treating cancer anorexia cachexia.

No toxicity studies exist for the combined therapy used in the patients included in the study. However, there exist some studies on separate compounds used in the therapy. However, all the formulations used in these patients are based on the compounds mentioned in Ayurveda classics and have a long history in the treatment of various health conditions. Besides these all the patients included in the study well tolerated the Rasayana therapy. No Grade III or Grade IV toxicity was seen in any patients. These facts and observations indicate that Rasayana therapy is well tolerated and safe.

Although this study clearly demonstrated the role of Rasayana therapy in effectively treating cancer anorexia cachexia, due to the limitations of observational study, it cannot explore the mechanism of action. Considering the important role of inflammatory mediators in cancer anorexia cachexia a prospective study evaluating the effect of these Rasayana compounds on markers of inflammation can put light on the probable mechanism of action.[25]


 > Conclusion Top


Cancer anorexia cachexia not only decreases patients QoL but it is also related to several adverse outcomes such as decreased survival, increased toxicity to chemotherapy, and even mortality. Rasayana therapy with calcined metallic compounds such as suvarnasindoor, suvarnabhasma, and hirak bhasma has showed significant improvement in increasing patient's weight, appetite, and overall health-related QoL. Rasayana therapy can be considered as an effective therapeutic option for treating patients with cancer anorexia cachexia.

Acknowledgment

We sincerely thank all the patients of Rasayu cancer clinic who provided us with their clinical data and gave a voluntary consent for using this data for analysis and making scientific communications.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
 > References Top

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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