Reviewed: Belcaro G, Hosoi M, Pellegrini L, et al. A controlled study of a lecithinized delivery system of curcumin (Meriva®) to alleviate the adverse effects of cancer treatment. Phytother Res. March 2014;28(3):444-450.
Cancer is a leading cause of death, and medical research on cancer often is geared toward treatment rather than prevention or supportive care. Botanicals and dietary supplements may help both to prevent cancer and to support patients with cancer who are recovering from conventional treatment; many botanicals also are well tolerated. Curcumin, a bioactive compound found in turmeric (Curcuma longa, Zingiberaceae) root, has been shown to have anti-cancer activity through multiple mechanisms. Despite its potential efficacy, curcumin possesses problematically low bioavailability, and increasing the dosage for patients with cancer may be untenable in terms of compliance. Since a lecithinized preparation of curcumin (Meriva®; Indena S.p.A; Milan, Italy) has been shown to have increased bioavailability, this placebo-controlled study investigated the effect of Meriva consumption on reducing adverse effects from non-surgical treatments of patients with cancer.
Patients were enrolled if they were undergoing either chemotherapy or radiation treatment, had cancer surgery a month or more prior to the study, and had normal liver and kidney function. The Karnofsky Scale was used to gauge patients’ general health; this scale ranges from 100 (normal functioning) to 10 (imminent fatal condition). Enrolled patients had a Karnofsky score of ≥ 70, were free of infection, had clinically significant adverse side effects (ASEs) caused by cancer treatment, and had elevated plasma free radicals as measured by ferric reducing ability of serum (FRAS) assay.
Those receiving chemotherapy had various solid tumors (91%) or hematological malignancies (9%); 65% had no detectable metastases. The chemotherapy treatment had begun one month or more following surgery, and none had undergone prior chemotherapy. Patients undergoing radiotherapy had only solid tumors; 78.4% had no signs of metastasis. They did not have any severe blood test alterations or metabolic problems and had not had radiation treatment prior to this study. All patients were screened for thrombosis at inclusion and at termination of the study.
Patients recorded any ASEs beginning after the first round of chemotherapy or radiation treatment. ASEs were noted if they lasted longer than three days; needed medical attention, treatment, or hospitalization; or interfered with patients’ work or social lives. ASEs were gauged on a 10-point scale ranging from 0 (no ASE) to 10 (life-threatening or severe ASE). Clinic visits were conducted at screening, at the end of the first round of cancer treatment, and after two months. Also, patients were visited or called by study administrators every two weeks.
Treatment consisted of either one tablet (500 mg) of Meriva or placebo after major meals, three times daily. Treatment began after the completion of the initial round of chemotherapy or radiation and continued for at least 60 days. Meriva consisted of 100 mg of curcuminoids (curcumin:demethoxycurcumin:bis-demethoxycurcumin ratio of 33:8:1), 200 mg of soy (Glycine max, Fabaceae) lecithin, and 200 mg of microcrystalline cellulose. The placebo was described as “comparable” but without curcuminoids or soy lecithin. In total, 160 patients undergoing either chemotherapy (n=80) or radiation treatment (n=80) were enrolled, ranging from 35-70 years of age. These two groups were further subdivided into those that received either Meriva (n=40) or placebo (n=40) along with the standard chemotherapy or radiation treatment for each specific type of cancer. Two patients from the chemotherapy placebo group dropped out due to administrative problems, but all patients in the radiation group finished the study.
At the end of the study, the percentage of those undergoing chemotherapy and consuming Meriva who reported nausea and vomiting, diarrhea or constipation, malnutrition or weight loss, memory or cognitive problems, infections, neutropenia (low neutrophilic white blood cell count), cardiotoxicity, or necessity of medication for chemotherapy ASEs was significantly less as compared to the control group (P<0.05 for each). After two months of treatment, those taking Meriva while undergoing chemotherapy reported significantly less nausea and vomiting, diarrhea or constipation, fatigue, malnutrition or weight loss, and memory or cognitive problems as compared to those in the placebo group (P<0.05 for each). Also, those consuming Meriva had a significantly lower plasma free radical status after two months than the control (389 ± 33 Carr units vs. 478 ± 39 Carr units, respectively, P<0.022), and as compared to baseline (P<0.021).
In those undergoing radiation treatment, a significantly lower percentage of patients taking Meriva reported suffering from the ASEs of epithelial damage, alimentary damage, mouth and throat soreness and ulcers, swallowing difficulties, sore esophagus, diarrhea and nausea, lower limb edema, fatigue, and weakness, or necessity of medication for radiotherapy ASEs, as compared to those in the placebo group (P<0.05 for each). After two months of treatment, those taking Meriva reported ASE scores significantly less than those in the placebo group (P<0.05) for each of the following: nausea and vomiting, diarrhea and constipation, fatigue, malnutrition and weight loss, memory and cognitive problems, and pain or swelling at treatment site. At the study’s end, plasma free radical status of those in the Meriva group was significantly less than that of the placebo group with 382 ± 29 Carr units vs. 476 ± 42 Carr units, respectively (P<0.022). This significant difference in plasma free radicals also was seen in the Meriva patients after two months as compared to their baseline assessment (P<0.021). Compliance was greater than 97%, and tolerability was good. Meriva consumption itself did not cause any ASEs that were “clinically significant.”
This study reports significant improvement in both the occurrence and severity of chemotherapy and radiation treatment ASEs in those consuming Meriva. This suggests broad bioactivity of the supplement, as ASEs for cancer treatment may be diverse. Importantly, as the authors note in their conclusion, these findings do not demonstrate that Meriva has a direct, “positive effect on the course of the disease … nor disprove the risk that curcumin, as an antioxidant, might interfere with cancer treatment.” The results observed here in a short period of time (two months) with a relatively low dose of curcuminoids (300 mg/day) point to improved bioavailability, although no testing for curcumin or its metabolites in plasma or urine was completed. Future studies will ideally include these parameters.
—Amy C. Keller, PhD