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Property:Exclusion criteria

From CAMIH

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Allergy to lycopene; hearing loss; significant neuropathy; metastatic renal involvement  +
Suffering from any other underlying diseases; being addicted to cigars, tobacco and opioid drugs; having a history of sensitivity to aloe vera; developing any kind of sensitivity to any material during the study; developing any acute condition during the study; and unwillingness to continue participation in the study  +
History of radiation therapy or chemotherapy in previous year, chemotherapy protocol in addition to radiotherapy, any allergy to condiments, especially "Turmeric root", any complications due to the use of topical gel during the study, suffering from any kind of oral disease such as active oral infection, ulcer, having any systemic disease or taking any medication  +
Women of child-bearing age and patients with a mechanical obstruction to feeding, medical treatments inducing significant changes in patient metabolism or body weight, and a history of thromboembolism.  +
Participants who had undergone prostatectomy prior to radiation therapy or who had metastatic disease at the time of radiation therapy  +
Palliative indications for pelvic irradiation; existence of a colostomy; known intolerance to proteolytic enzyme preparations or to contents of the study medication; participation in other clinical studies within the last 30 days  +
Patients who were scheduled to receive radiotherapy during the study period, were pregnant or lactating, concurrently used other ginger-containing supplements or ingested large quantities of ginger, had a history of adverse reactions to ginger, and/or thrombocytopenia.  +
Patients with prior upper aerodigestive tract cancers within the past 5 years, or with synchronous cancers of the esophagus or lung  +
Patients having an active infection, inability or unwillingness to take vitamin supplementation, had taken any vitamins within the past 28 days or receiving concomitant radical chemotherapy and radiotherapy or antiepileptic treatment  +
Patients who underwent definitive surgery (anything beyond excisional biopsy), those with Stage IVc disease (nonregional metastatic disease), those with malignancy within the previous five years, prior radiotherapy, HIV or hepatitis C positivity, platinum hypersensitivity, inability to tolerate oral medications (in absence of feeding tube), symptomatic peripheral neuropathy, planned use of amifostine, and significant comorbidity  +
Patients with co‑morbidities like diabetes, autoimmune diseases which include lupus, rheumatoid arthritis, kidney disease, liver disease and thyroid (hypothyroidism, tested pre‑enrollment by thyroid‑stimulating hormone, T4, T3) and with infections like hepatitis C and human immunodeficiency virus/acquired immunodeficiency syndrome (HIV)/AIDS (all patients would undergo laboratory confirmation for shingles, hepatitis B, C and HIV/AIDS (at any Voluntary Confidential Counselling and Testing Centre, India) prior to inclusion in study), spinal cord injuries, peripheral vascular disorders known to be associated with peripheral neuropathy; uncontrolled diabetes or compromised cardiac function or any other major organ dysfunctions, other than cancer, which would require curtailment of full doses of paclitaxel at 175 mg/m<sup>2</sup>, 3 weekly regimens  +
concurrent disease (diabetes mellitus, hypertension, autoimmunedisorder, chronic infllammation, cardiac disease, etc.), previously administration of cytotoxic chemotherapy or radiotherapy, patients refusal, infection of mouth and systemic infection and patients with interruption in the treatment  +
Patients with metastatic disease, diarrhea before radiotherapy, radiochemotherapy, or supplementation of selenium before radiotherapy, as well as patients who had undergone previous pelvic radiotherapy  +