Intervention:

Behavioural:

Questionnaires for patient/family caregiver interview

BIDHU K MOHANTI, MD

Jaspreet Kaur, MD

Bidhu K MOHANTI, MD

Jaspreet KAUR, MD

Sudhir K Khandelwal, MD

Ravindra M Pandey, PhD

The purpose of this study is to assess the various aspects of life in the cancer survivors in India. Cancer survivor is defined as "an individual diagnosed with cancer and who has survived the disease and treatment, and for the rest of his/her life".

Cancer survivors are at increased risk of developing various physical and psychosocial conditions, which require to be identified and attended within the cancer care system.

Survivorship research is seen as addressing the medical, functional, and health related issues of individuals diagnosed with cancer, as well as that of their families.

It is estimated that approximately 25 million people are living as cancer survivors worldwide. The cancer survivors are those individuals who live beyond a cancer diagnosis and its therapy. Within the existing health care system, the cancer care models are largely focused on diagnostic methods, treatment aspects, cure, and disease failure and survival rates. There is very little research and intervention approaches for the after-effects of cancer diagnosis and treatments for an individual cancer patient. Cancer survivors are at increased risk of developing various physical and psychosocial conditions, which require to be identified and attended within the cancer care system. In the developing countries like India, the cancer cure rates are improving due to improvements in comprehensive diagnostic and treatment strategies. Cancer survivorship research will be valuable to enhance our understanding and care approaches to these vulnerable individuals in our society. There is lack of evaluation tools which can completely fit to assess all issues such as physical, social, financial, mental aspects of a cancer survivor.

Hence the investigators of this observational study have prepared an empirical cancer survivorship questionnaire (CSQ) which will document the patient's disease and treatment details and obtain subjective responses from the patient(and/or family care giver) related to the physical, functional, social, economic and mental aspects of daily living of a cancer survivor. In order to assess the mental status of the survivors, the investigators have also included the widely used and internationally accepted MINI (Mini-international neuropsychiatry interview) version along with the CSQ in this survey. Researchers and clinicians working in non-profit and academic setting such as this institution are allowed to make copies of this MINI questionnaire for the purpose of clinical and research use. For the present study, MINI version is suitably modified to exclude the items which are already in the CSQ, and certain items are reframed for the socio-cultural requirement. Both the CSQ (45 items) and MINI-modified (13 items) will be applied simultaneously in this survey as a direct face to face response documentation from the patient (cancer survivor), along with his/her family member. Patients will be chosen for this cross-sectional survey during the follow-up visit to a cancer clinic of this hospital, at least 3 months after the completion of cancer diagnosis and therapy. Each participant is expected to complete the survey at the first encounter, however, a provision is made to report any missing information at later visit.

An interim analysis will be carried out after the survey of first 50 patients to observe the trends in the findings. However, this will not impact the further accrual, except for making some changes in the survey parameters if at all needed.

Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)

Behavioral: Questionnaires and medical records. The cancer survivors' physical, social, economic and psychological issues will be assessed as verbal response.The survey questionnaires will document the sequelae of cancer and its treatment during the face to face interview and by collecting information from the individual cancer survivor's medical records

Behavioral:MINI-international neuro-psychiatric questionnaire(modified for local use)

This cancer survivorship survey will include adult cancer survivors post-therapy. Survivors of various neoplasms will be accrued for this survey.

This survey of 200 adult cancer survivors will analyse various issues-physical, social, psychological and economic which adversely impact the life of cancer survivors in India.

This analysis will help in evolving a feasible approach towards implementation of follow up care practice for cancer survivors.

All India Institute of Medical Sciences, New Delhi

Professor Department of Radiation Oncology

Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Zhouguang Hui, Ph.D.

Zhouguang Hui, M.D.

Malignant pleural mesothelioma (MPM) is a highly aggressive tumor with atypical clinical manifestations. Most patients with MPM are at an advanced stage at the time of diagnosis, and only a few patients can be cured by radical surgery and other treatment measures. Pemetrexed + cisplatin chemotherapy with or without bevacizumab is still the standard treatment for MPM. In recent years, multimodality therapy including surgery, radiotherapy and chemotherapy have shown certain advantages in improving patient overall survival time. Targeted and immunotherapy may bring breakthroughs in MPM therapy. However, there are still no high-quality evidence-based medical evidence reports on the treatment model and effects of MPM patients in China.

Focusing on MPM, we plan to systematically review the relevant scientific literature, confirm relevant scientific research questions, and provide references for related treatments. On this basis, we will estimate MPM incidence and mortality rates from 2014 to 2025 based on the data published by the National Cancer Registry. Meanwhile, a retrospective study cohort was constructed based on the electronic medical record database, and according to the research demand, patients were followed up with their post-discharge survival status to comprehensively describe and analyze the incidence, diagnosis, treatment, and prognosis of MPM patients. Also, exploratory analysis of the therapeutic effects of existing clinical treatments was conducted.

Real World Study of MPM in China

Real World Study of Diagnosis, Treatment and Prognosis of Malignant Pleural Mesothelioma in China

Overall survival is defined as the time from diagnosis to death for any reason or last follow-up

Progression-free survival is defined as the time from diagnosis to the first event of progression

Chinese Academy of Medical Sciences

M.D.

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Analgesics

Herbal and Botanical

Liver Extracts

Mitogens

Interleukin-2

Cola

The number of patients suffering from well-documented malignancies to be assigned to this group will be at least 30: with mixed types of carcinoma of breast, lung, colon, gastro-intestinal, ovarian, cervical, uterine, prostatic, bladder, hepatic, lymphoma, melanoma and so forth. These patients will be given Bromelain at 500 mg/day, divided into two doses of 250 mg/dose and taken with meals.

The number of patients suffering from well-documented malignancies with be at least 60: with mixed types of carcinoma of breast, lung, colon, gastro-intestinal, ovarian, cervical, uterine, prostatic, bladder, hepatic, lymphoma, melanoma and so forth. These patients will be given Bromelain at 2400 mg/day, divided into two doses of 1200 mg/dose and taken with meals.

Treatment of solid tumors in advanced stage of lung, breast, colon, ovary, cervix, uterus, prostatic, and liver

Bromelain and Comosain

Benedict Liao, M.D.

Masao Wada, M.D.

Lewis Hamilton, M.D.

The Phase II randomized, two-armed clinical study will investigate the efficacy of high dose versus low dose Bromelain (Comosain) in human subjects diagnosed with advanced late stage cancers. The study subjects will be randomly assigned to each group by a coin toss. Bromelain (Comosain) extract, derived from the stem and fruit of Ananas Comosus will be administered orally each day.

1. Patient Eligibility and Selection

   Patients suffering from late stage breast, lung, colon, cervical, ovarian, and uterine cancers in stages III and IV, with tissue proof of well-documented malignancies, whether by tissue biopsies and/or laparatomy or thoracotomy and have not been helped by conventional radiation therapy and/or chemotherapies are eligible for this study. Additionally the following conditions must be met:
   1. Patient's age is between 18 and 85 years.
   2. Patient is not taking anticoagulants or on antiplatelet therapy.
   3. Patient does not have a history of abdominal fistula, gastroenteral perforation, peptic ulcer diseases, or intra-abdominal abscess within 6 months prior to study enrollment.
   4. Patient has not had major surgery within 4 weeks prior to study enrollment. Patients who have not recovered from adverse events due to surgery performed more than 4 weeks earlier are not eligible for this study.
   5. Patient does not currently have uncontrolled hypertension, diabetes, or clinically significant cardiac arrhythmia.
   6. Patient does not have an allergic reaction to Bromelain or pineapple-containing products.
   7. Female patients should not be pregnant or breastfeeding.
   8. Patient's platelet counts must be greater than 100,000/mL.
   9. Patient's hemoglobin must be greater than 9.0 g/dL.
   10. Patient does not have significant abnormal hepatic and/or renal function.
   11. Patient's tumors are measurable; between 0.2 - 10 cm in size and number between 1 - 15. All measurable tumors that have spread to the bones, liver, lung, kidney, and abdomen will be included in the data analysis.

   Patients with following conditions will be excluded from the study:
   1. Hemoglobulin less than 9 g/dL and WBC less than 4.0 k/µL.
   2. Platelet count less than 100,000/µL.
   3. INR greater than 1.5
   4. Patient currently taking therapeutic doses of warfarin or anti anti-platelet agents.
   5. Patient has a history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.
   6. Patient currently has uncontrolled hypertension, diabetes, or clinically significant cardiac arrhythmia.
   7. Patient who had major surgery performed within 4 weeks prior to entering the study; and patients who have not recovered from adverse events due to surgery performed more than 4 weeks earlier.
   8. Patient with a history of allergic reaction to Bromelain or pineapple-containing products.
   9. Female patients who are pregnant or breastfeeding.
   10. Patient with tumors that are widely spread in the chest and abdomen that cannot be measured by CT scan.

   Patients who are eligible for this study will be randomly assigned to either the low dose group or the high dose group by a coin toss. Each study subject will be assigned a patient number for the purpose of this study.
2. Drug Dosage and Schedule

   High Dose Group-The oral dose of Bromelain (50 mg/kg/day) is extrapolated from in vivo animal studies, and determined to be safe by a Safety study on healthy human subjects (see Section VII-A). For this clinical investigation, the High Dose group will be given Bromelain at 50 mg/kg/day, to a maximum of 2400 mg/day (divided into 2 doses/day of 1200 mg/dose)

   Low Dose Group - Low Dose group will be given 10 mg/kg/day, to a maximum of 500 mg/day (divided into 2 doses/day of 250 mg/dose).

   The number of patients suffering from well-documented malignancies to be assigned to this group will be at least 30: with the combination of mixed types carcinoma of breast, lung, colon, gastro-intestinal, ovarian, cervical, uterine, prostatic, hepatic, bladder, lymphoma, melanoma, and so forth. These patients will be given Bromelain at 500 mg/day, divided into two doses of 250 mg/dose and taken with meals.

   High Dose Group - The dose will be at 50 mg/kg/day, The number of patients suffering from well-documented malignancies with be at least 60: with the combination of mixed types carcinoma of breast, lung, colon, gastro-intestinal, ovarian, cervical, uterine, prostatic, hepatic, bladder, lymphoma, melanoma, and so forth. These patients will be given Bromelain at 2400 mg/day, divided into two doses of 1200 mg/dose and taken with meals.
3. Duration and Route of Administration Study subjects will be provided with Bromelain for oral administration. The containers will be clearly labeled (see Section V-E). Bromelain will be taken orally twice daily with meals. On their biweekly visits to the Doctor's Office, the Study patients will be provided with enough doses for two weeks. The study patients are required to keep a journal of the daily doses they take and any side effects they experience.

The study patients will be evaluated using blood tests and CT scans at six months for signs of disease progression. If the disease did not progress, then treatment will continue and the patient will be evaluated every six months thereafter until the investigator determines otherwise. If the disease did progress, then the patient will be taken off the study.

Bromelain, Comosain as a New Drug for Treating and Preventing Various Types of Cancer in the Humans

The Methods and Compositions for Treating / Preventing Various Types of Cancer Which Comprise Administered an Effective Amount of Glyco-Polypeptides, Such as Comosain, Bromelainases, Ananase, and a Mixture Thereof. By Way of (a) MMAPKinase (Major Mitogen Activiting Protein Kinase), (b) TPKinase (Tryosine Phosphorylation Kinase) Inhibitors Which Induce Cascade Production of Interleukin II B, 6, 8 & TNFs Through TCRs/ CD-2, TCRs/ CD-3 of WBC

Using standard serious and non-serious toxicity measurement in hematology, hepato-reno systems in cancer patients

Measurement of the size of tumor lesion in centimeters and shrinking of regional lymphnodes

Measurement of the non-target lesions (tumor markers) values decrease or increase by laboratory tests

Oeyama-Moto Cancer Research Foundation

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.

Standard Treatments of Very-early Stage Hepatocellular Carcinoma

The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial

Hepatocellular Carcinoma will recurrence in 3 years

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)	NCT01304199	Cancer		18 Years - 75 Years	All India Institute of Medical Sciences, New Delhi
Real World Study of MPM in China	NCT05042557	Malignant Pleur... Diagnoses Disea... Treatments Prognosis		18 Years -	ChineseAMS
Bromelain, Comosain as a New Drug for Treating and Preventing Various Types of Cancer in the Humans	NCT02340845	Cancer	Bromelain and C...	18 Years - 85 Years	Oeyama-Moto Cancer Research Foundation
Bromelain, Comosain as a New Drug for Treating and Preventing Various Types of Cancer in the Humans	NCT02340845	Cancer	Bromelain and C...	18 Years - 85 Years	Oeyama-Moto Cancer Research Foundation
Standard Treatments of Very-early Stage Hepatocellular Carcinoma	NCT02728193	Hepatocellular ... Very-early Stag...	RFA MWV PEI	18 Years - 70 Years	Eastern Hepatobiliary Surgery Hospital

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Every month we try and update this database with for treatments cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for treatments

Every month we try and update this database with for treatments cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for treatments cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.