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Publication: Favorable Effects of a Ketogenic Diet on Physical Function, Perceived Energy, and Food Cravings in Women with Ovarian or Endometrial Cancer: A Randomized, Controlled Trial +
Ketogenic diets (KDs) are gaining attention as a potential adjuvant therapy for cancer, but data are limited for KDs’ effects on quality of life. We hypothesized that the KD would (1) improve mental and physical function, including energy levels, (2) reduce hunger, and (3) diminish sweet and starchy food cravings in women with ovarian or endometrial cancer. Participants were randomized to a KD (70:25:5 energy from fat, protein, and carbohydrate) or the American Cancer Society diet (ACS: high-fiber, lower-fat). Questionnaires were administered at baseline and after 12 weeks on the assigned diet to assess changes in mental and physical health, perceived energy, appetite, and food cravings. We assessed both between-group differences and within-group changes using ANCOVA and paired t-tests, respectively. After 12 weeks, there was a significant between-group difference in adjusted physical function scores (p < 0.05), and KD participants not receiving chemotherapy reported a significant within-group reduction in fatigue (p < 0.05). There were no significant between-group differences in mental function, hunger, or appetite. There was a significant between-group difference in adjusted cravings for starchy foods and fast food fats at 12 weeks (p < 0.05 for both), with the KD group demonstrating less frequent cravings than the ACS. In conclusion, in women with ovarian or endometrial cancer, a KD does not negatively affect quality of life and in fact may improve physical function, increase energy, and diminish specific food cravings. This trial was registered at ClinicalTrials.gov as NCT03171506. +
Publication: Feasibility, Safety, and Beneficial Effects of MCT-Based Ketogenic Diet for Breast Cancer Treatment: A Randomized Controlled Trial Study +
The present study was aimed to evaluate the safety, tolerability, and beneficial effects of a ketogenic diet (KD) on body composition and blood parameters and survival in patients
with breast cancer. In this randomized, controlled trial, 60 patients with locally advanced or metastatic breast cancer and planned chemotherapy, were randomly assigned to a group receiving KDs (n = 30) or to a control group with standard diet (n = 30) for 3 months. Serum biochemical parameters and body composition were analyzed at baseline, every 3 weeks and end of each arm. Compliance and safety of KD were also checked weekly. Fasting blood sugar (FBS) was significantly decreased in intervention group compared to the baseline (84.5 ± 11.3 vs. 100.4 ± 11.8, P = 0.001). A significant inter-group difference was also observed for FBS level at end of intervention. There was an increasing trend in serum levels of ketone bodies in intervention group (0.007–0.92, P < 0.001). Compared to the control group, BMI, body weight, and fat% were significantly decreased in intervention group in last visit (P < 0.001). No severe adverse side effect was found regarding lipid profile and kidney or liver marker. Overall survival was higher in KD group compared to the control group in neo-adjuvant patients (P = 0.04). Our results suggested that chemotherapy combined with KDs can improve the biochemical parameters, body composition, and overall survival with no substantial side effects in patients with breast cancer. +
Publication: Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: a URCC CCOP study of 576 patients +
Purpose Despite the widespread use of antiemetics, nausea continues to be reported by over 70% of patients receiving chemotherapy.
Methods In this double blind, multicenter trial, we ran- domly assigned 744 cancer patients to four arms: 1) placebo, 2) 0.5 g ginger, 3) 1.0 g ginger, or 4) 1.5 g ginger. Nausea occurrence and severity were assessed at a baseline cycle and the two following cycles during which patients were taking their assigned study medication. All patients received a 5-HT3 receptor antagonist antiemetic on Day 1 of all cycles. Patients took three capsules of ginger (250 mg) or placebo twice daily for 6 days starting 3 days before the first day of chemotherapy. Patients reported the severity of nausea on a 7-point rating scale (“1” = “Not at all Nauseated” and “7” = “Extremely Nauseated”) for Days 1–4 of each cycle. The primary outcomes were to determine the dose and efficacy of ginger at reducing the severity of chemotherapy-induced nausea on Day 1 of chemotherapy. Results A total of 576 patients were included in final analysis (91% female, mean age = 53). Mixed model analyses demonstrated that all doses of ginger significantly reduced acute nausea severity compared to placebo on Day 1 of chemotherapy (p=0.003). The largest reduction in nausea intensity occurred with 0.5 g and 1.0 g of ginger (p=0.017 and p=0.036, respectively). Anticipatory nausea was a key factor in acute chemotherapy-induced nausea (p < 0.0001). Conclusions Ginger supplementation at a daily dose of 0.5 g– 1.0 g significantly aids in reduction of the severity of acute chemotherapy-induced nausea in adult cancer patients. +
Background: Vomiting is one of the most prevalent side effects of chemotherapy in cancer patients. The aim of this study was to evaluate the effect of ginger plant on chemotherapy-induced vomiting, since the previous studies were somehow imperfect and have provided controversial results.
Materials and Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 80 women with breast cancer undergoing chemotherapy and suffering from vomiting in Imam Khomeini Hospital, Tehran, Iran, between July and December 2009. During a convenience sampling the participants were randomly allocated into treatment and placebo arms after taking a written informed consent. Two arms were matched based on the age and emetic risk of chemotherapy drugs. The treatment group received 250 mg ginger powder capsules (Zintoma) and placebo group 250 mg starch capsules 4 times a day (1 g/day) for 6 days since 3 days before chemotherapy session. A two-part self-made questionnaire was used to assess the effect of ginger. Patients completed the instrument every day. Then by STATA software version 8, the gathered data were analyzed using Fisher’s exact, Kruskal–Wallis, and Chi-square tests.
Results: The 2 arms had no significant age differences and were matched (ginger: 41.8±8.4 vs placebo: 45.1±10, P = 0.1). Vomiting cases were significantly lower in ginger group at anticipatory (P = 0.04), acute (P = 0.04), and delayed (P = 0.003) phases. Also, heartburn was the only and venial reported side effect (P > 0.05).
Conclusions: Taking ginger capsules (for 6 days since 3 days before chemotherapy) accompanied by the routine antiemetic treatment could relieve chemotherapy-induced vomiting in all phases. +
Publication: Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: A randomized, cross-over, double blind study +
Objective: To study the antiemetic effect of ginger root on nausea and vomiting induced by cyclophosphamide.
Methods: A randomized, prospective, cross-over, double-blind study was carried out in patients receiving cyclophosphamide in combination with other chemotherapeutic agents. Patients with atleast two episodes of vomiting in the previous cycle were included. The patients were randomly assigned to receive one of the three antiemetics: ginger, metoclopramide or ondansetron in the first cycle. They were admitted in the ward for 24 h and observed for the incidence of nausea and vomiting and adverse effects if any, were recorded. Patients were crossed over to receive the other antiemetic treatments during the two successive cycles of chemotherapy.
Results: Complete control of nausea was achieved in 62% of patients on ginger, 58% with metoclopramide and 86% with ondansetron. Complete control of vomiting was achieved in 68% of patients on ginger, 64% with metoclopramide and 86% with ondansetron. No adverse effects attributable to ginger were recorded.
Conclusion: Powdered ginger root in the dose used was found to be effective in reducing nausea and vomiting induced by low dose cyclophosphamide in combination with drugs causing mild emesis. The antiemetic efficacy of ginger was found to be equal to that of metoclopramide but ondansetron was found to be superior than the other two. +
Publication: Green tea improves metabolic biomarkers, not weight or body composition: a pilot study in overweight breast cancer survivors +
Background: Overweight status after breast cancer treatment may increase a
woman’s risk for recurrent disease and/or early onset cardiovascular disease.
Green tea has been proposed to promote weight loss and favourably modify
glucose, insulin and blood lipids. This pilot study tested the effect of daily
decaffeinated green tea consumption for 6 months on weight and body composition,
select metabolic parameters and lipid profiles in overweight breast cancer
survivors.
Methods: The effect of daily decaffeinated green tea intake on weight, body
composition and changes in resting metabolic rate, energy intake, glucose,
insulin, homeostasis model assessment – insulin resistance (HOMA-IR) and
lipids was evaluated in overweight breast cancer survivors. Participants had a
mean weight of 80.2 kg; body mass index (BMI) 30.1 kg m)-2; and body fat
46.4%. Participants (n = 54) were randomised to 960 mL of decaffeinated
green or placebo tea daily for 6 months.
Results: Mean (SD) tea intake among study completers (n = 39) was
5952 (1176) mL week)-1 and was associated with a significant reduction in
energy intake (P = 0.02). Change in body weight of -1.2 kg (green tea) versus
+0.2 kg (placebo) suggests a weight change effect, although this was not statistically
significant. Decaffeinated green tea intake was associated with elevated
high-density lipoprotein (HDL) levels (P = 0.003) and nonsignificant improvements
in the HDL/LDL ratio and HOMA-IR ()1.1 ± 5.9: green tea;
+3.2 ± 7.2: herbal).
Conclusions: Intake of decaffeinated green tea for 6 months was associated
with a slight reduction in body weight and improved HDL and glucose homeostasis
in overweight breast cancer survivors. +
Publication: Guarana (Paullinia cupana) Improves Fatigue in Breast Cancer Patients Undergoing Systemic Chemotherapy +
Background: In patients with breast cancer (BC) undergoing systemic chemotherapy, cancer-related fatigue (CRF) is a common problem that can negatively impact quality of life. Guarana (Paullinia cupana) is a plant native to the Amazon basin that has been used as a stimulant since pre-Columbian times.
Objective: The purpose of this study was to evaluate the effectiveness of guarana extract on fatigue, sleep quality, anxiety, depression symptoms, and menopause in a group of BC chemotherapy patients.
Patients and methods: Patients with progressive fatigue after their first cycle of chemotherapy were randomized to receive either guarana 50 mg by mouth twice daily (32 patients) or placebo (43 patients) for 21 days. After a 7-day washout period, patients were crossed over to the opposite experimental arm. All patients were evaluated on days 1, 21, and 49. The primary endpoint was the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire score, and secondary endpoints were the results of the Functional Assessment of Chronic Illness Therapy-Endocrine Symptoms (FACT-ES), Brief Fatigue Inventory (BFI), Pittsburg Sleep Quality Index, Chalder Fatigue Scale, and Hospital Anxiety and Depression Scale.
Results: Guarana significantly improved the FACIT-F, FACT-ES, and BFI global scores compared to placebo on days 21 and 49 (p<0.01). The Chalder Scale improved significantly on day 21 (p<0.01) but not on day 49 (p1⁄40.27). Guarana did not produce any Common Terminology Criteria for Adverse Events grades 2, 3, or 4 toxicities and did not worsen sleep quality or cause anxiety or depression.
Conclusions: Guarana is an effective, inexpensive, and nontoxic alternative for the short-term treatment of fatigue in BC patients receiving systemic chemotherapy. Further studies are needed to confirm these results and to evaluate their generalizability to chronic CRF and to other types of cancer. +
Publication: Health-Related Quality-of-Life Outcomes: A Reflexology Trial With Patients With Advanced-Stage Breast Cancer +
Purpose/Objectives
To evaluate the safety and efficacy of reflexology, a complementary therapy that applies pressure to specific areas of the feet.
Design
Longitudinal, randomized clinical trial.
Setting
Thirteen community-based medical oncology clinics across the midwestern United States.
Sample
A convenience sample of 385 predominantly Caucasian women with advanced-stage breast cancer receiving chemotherapy and/or hormonal therapy.
Methods
Following the baseline interview, women were randomized into three primary groups: reflexology (n = 95), lay foot manipulation (LFM) (n = 95), or conventional care (n = 96). Two preliminary reflexology (n = 51) and LFM (n = 48) test groups were used to establish the protocols. Participants were interviewed again postintervention at study weeks 5 and 11.
Main Research
Variables
Breast cancer–specific health-related quality of life (HRQOL), physical functioning, and symptoms.
Findings
No adverse events were reported. A longitudinal comparison revealed significant improvements in physical functioning for the reflexology group compared to the control group (p = 0.04). Severity of dyspnea was reduced in the reflexology group compared to the control group (p < 0.01) and the LFM group (p = 0.02). No differences were found on breast cancer–specific HRQOL, depressive symptomatology, state anxiety, pain, and nausea.
Conclusions
Reflexology may be added to existing evidence-based supportive care to improve HRQOL for patients with advanced-stage breast cancer during chemotherapy and/or hormonal therapy.
Implications for Nursing
Reflexology can be recommended for safety and usefulness in relieving dyspnea and enhancing functional status among women with advanced-stage breast cancer. +
Publication: High-dose zinc oral supplementation after stem cell transplantation causes an increase of TRECs and CD4+ naive lymphocytes and prevents TTV reactivation +
Introduction: Zinc plays an important role in thymic function and immune homeostasis. We performed a pro- spective clinical trial using a high-dose zinc oral supplementation to improve the immune reconstitution after hematopoietic stem cell transplant (HSCT).
Patients and methods: We enrolled 18 patients undergoing autologous HSCT for multiple myeloma. Nine patients were randomized to receive only a standard antimicrobial prophylaxis; whereas, nine patients received in ad- dition 150 mg/day of zinc from day +5 to day +100 after transplant.
Results: CD4+ naïve lymphocytes and TRECs showed a significant increase from day +30 until day +100 only in the zinc-treated group. Moreover, the load of Torquetenovirus, a harmless virus that replicates in course of immunedepression, increased at day +100 only in the control group. No severe adverse events were reported during the zinc consumption.
Conclusion: First data from the ZENITH trial suggest that high-dose zinc supplementation is safe and may en- hance the thymic reconstitution after HSCT. +
Publication: Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study +
Background: A minority of early breast cancer (EBC) patients treated with adjuvant or neoadjuvant chemotherapy have sufficient baseline vitamin D (vitD) level. This randomized phase III study assessed the safety and efficacy of a tailored, high-dose, oral vitD supplementation in restoring a normal 25-hydroxy vitD (25OHD) level in this population.
Patients and methods: Participants received a 6-month conventional (C) vitD and calcium supplementation or a 6-month high-dose oral vitD regimen tailored on the deficiency (T) and a conventional calcium supplementation. The primary end point was the 6-month percentage of 25OHD serum level normalization.
Results: A total of 215 patients including 197 patients with vitD deficiency were recruited, and 195 patients were randomized (T, 100; C, 95). Compliance to the daily oral supplementation was 68.4% and 67% in the C and T arms, respectively. Discontinuous high-dose vitD compliance appeared higher in the T arm (77%). At 6 months, more patients presented with a normalized vitD level in the T arm (30% versus 12.6%; P = 0.003). Supplementation was well tolerated, and no significant difference in the treatment-related toxicity between the two arms was reported. Fifty-two patients without vitD normalization from the C arm switched to the T arm after 6 months. At 12 months, 44% of these patients achieved vitD normalization.
Conclusion: A tailored high-dose oral vitD supplementation safely allows a higher percentage of the serum 25OHD level normalization compared with a conventional regimen in chemotherapy-treated EBC patients. As compliance to a daily oral supplementation remains poor in this setting, an adaptation of the treatment schedule is warranted. +
Publication: Impact of treatment planning target volumen (PTV) size on radiation induced diarrhoea following selenium supplementation in gynecologic radiation oncology-a subgroup analysis of a multicenter, phase III trial +
Background: In a previous analysis (Int J Radiat Oncol Biol Phys 70:828-835, 2010), we assessed whether adjuvant supplementation with selenium (Se) improves Se status and reduces the radiation-induced side effects of patients treated by adjuvant radiotherapy (RT) for cervical and uterine cancer. Now, a potential relation between the planning target volume (PTV) of the RT and the Se effect concerning radiation-induced diarrhea was evaluated in detail.
Methods: Whole blood Se concentrations had been measured in patients with cervical (n=11) and uterine cancer (n=70) after surgical treatment, during, and at the end of RT. Patients with initial Se concentrations of less than 84 μg/L were categorized as Se-deficient and randomized before RT to receive Se (as sodium selenite) per os on the days of RT or to receive no supplement during RT. Diarrhea was graded according to the Common Toxicity Criteria system (CTC, Version 2a). The evaluation of the PTV of the RT was ascertained with the help of specialized computer-assisted treatment planning software used for the radiation planning procedure.
Results: A total of 81 patients had been randomized for the initial supplementation study, 39 of which received Se (selenium group, SeG) and 42 serving as controls (control group, CG). Mean Se levels did not differ between SeG and CG upon study initiation, but were significantly higher in the SeG compared to the CG at the end of RT. The actuarial incidence of at least CTC 2 radiation-induced diarrhea in the SeG was 20.5% compared to 44.5% in the CG (p=0.04). The median PTV in both groups was 1302 ml (916–4608). With a PTV of <= 1302 ml (n=41), the actuarial incidence of at least CTC 2 diarrhea in the SeG was 22.3% (4 of 18 patients) compared to 34.8% (8 of 23 patients) in the CG (p=0.50). In patients with a PTV of > 1302 ml (n=40), the actuarial incidence of at least CTC 2 diarrhea in the SeG was 19.1% (4 of 21 patients) versus 52.6% (10 of 19 patients) in the CG (p=0.046).
Conclusions: Se supplementation during RT was effective in improving blood Se status in Se-deficient cervical and uterine cancer patients and reducing episodes and severity of RT-induced diarrhea. This effect was most pronounced and significant in patients with large PTV (> 1302 ml).
Publication: Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial +
Objectives: Patients treated for head and neck carcinomas experience a significant deterioration of their quality of life during treatments because of severe side effects. Nabilone has many properties that could alleviate symptoms caused by radiotherapy and improve patients’ quality of life. The aim of the present study was to compare the effects of nabilone versus placebo on the quality of life and side effects during radiotherapy for head and neck carcinomas.
Methods: Fifty-six patients were randomized to nabilone or placebo. Patients filled the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H&N35; three independent questionnaires assessing appetite, nausea, and toxicity; and a visual analog scale for pain. These data were collected before radiotherapy, each week during radiotherapy, and 4 weeks after radiotherapy. Patients were weighed every week.
Results: Nabilone did not lengthen the time necessary for a 15% deterioration of quality of life (P = .4279), and it was not better than placebo for relieving symptoms like pain (P = .6048), nausea (P = .7105), loss of appetite (P = .3295), weight (P = .1454), mood (P = .3214), and sleep (P = .4438).
Conclusion: At the dosage used, nabilone was not potent enough to improve the patients’ quality of life over placebo. +
Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial +
In this study, vitamin C was administered at various times as a sour stimulant to thyroid cancer patients, and the effect on salivary absorbed dose of therapeutic radioiodine (131I) was investigated.
Methods: Patients with differentiated thyroid cancer who had been prepared for thyroid remnant ablation after total thyroidectomy were prospectively recruited and, using a random-number table, were divided into 4 groups. In the hypothyroid condition, the patients in groups A, B, C, and D began sucking vitamin C (100 mg every 4 h in the daytime over 6 d) at 1, 5, 13, and 25 h, respectively, after receiving 3.7 GBq of (131)I. Scintigraphic images of the head and neck were serially acquired after (131)I administration to assess biokinetics in the salivary glands. Calculation of salivary absorbed dose was based on the MIRD schema of the Society of Nuclear Medicine.
Results: Seventy-two patients (18, 18, 19, and 17 patients from groups A, B, C, and D, respectively) were eligible for the analysis of salivary dosimetry. Differences in absorbed doses to the parotid salivary gland (0.18 +/- 0.11, 0.16 +/- 0.07, 0.16 +/- 0.09, and 0.16 +/- 0.12 mGy/MBq in groups A, B, C, and D, respectively; P = 0.37) and submandibular salivary gland (0.19 +/- 0.05, 0.17 +/- 0.05, 0.18 +/- 0.07, and 0.17 +/- 0.06 mGy/MBq, respectively; P = 0.28) were not statistically significant among groups. Salivary cumulated activities arising from the first 24 h after (131)I administration accounted for 86.08% +/- 7.89% (range, 75%-98%) of total cumulated activities. Differences in salivary absorbed dose during the first 24 h were not statistically significant among the 4 groups either (P = 0.32 and 0.24, respectively, for the parotid and submandibular salivary glands).
Conclusion: Salivary stimulation with vitamin C at any time after (131)I administration has only a limited effect on salivary absorbed dose in thyroid cancer patients. +
Publication: Intravenous Carnitine Administration in Addition to Parenteral Nutrition With Lipid Emulsion May Decrease the Inflammatory Reaction in Postoperative Surgical Patients +
Background:
A prospective randomized study was performed to investigate the validity of intravenous carnitine administration during postoperative parenteral nutrition (PN) with lipid emulsion.
Methods:
Patients undergoing surgery for gastric or colorectal cancer were enrolled in the study and were randomly divided into two groups (n = 8 in each group): 1) group L, who received a peripheral PN (PPN) solution of 7.5% glucose, 30% amino acid, and 20% lipid emulsion; and 2) group LC, who received the same PPN solution, as well as carnitine intravenously. PPN was performed from postoperative day (POD) 1 to POD4. Clinical and laboratory parameters were compared between the two groups; statistical significance was set at P < 0.05.
Results:
Serum carnitine concentrations were significantly higher in group LC on POD3 (P < 0.01) and POD7 (P = 0.01). Postoperative changes in laboratory parameters and morbidity were comparable between the two groups. However, the decrease in C-reactive protein from POD3 to POD7 was significantly greater in group LC than in group L (P = 0.011).
Conclusion:
The results show that intravenous carnitine administration in addition to PN is safe and may be beneficial for recovery from postoperative inflammatory reactions. +
Publication: Is reflexology as effective as aromatherapy massage for symptom relief in an adult outpatient oncology population? +
Aim: To test whether reflexology was inferior to aromatherapy massage for ameliorating self-selected problems or concerns.
Design: Non-blinded, randomised study with a 1:1 allocation.
Adult outpatients recruited from a UK cancer centre, randomised by the minimisation method to either four aromatherapy massage or four reflexology sessions.
Outcome measures: MYCaW scores at baseline and completion; VAS (relaxation) pre and post-sessions.
Analysis: Unpaired t-test for the primary outcome; analysis of variance tests for repeated measures for VAS (relaxation); descriptive statistics (means and 95% confidence intervals) and content analysis for patient comments.
Results: 115 subjects (58 aromatherapy massage, 57 reflexology) recruited. Reflexology was found to be no less effective than aromatherapy massage for MYCaW first concerns (p=0.046). There was no statistical difference between groups for MYCaW second concerns or overall well-being scores, proportions of patients gaining clinical benefit, VAS scores over time (p=0.489) or between groups (p=0.408) or in the written responses. +
Background and aims: The effect of perioperative treatment with L-carnitine in hepatectomized patients is unclear. The objectiveof the current study is to evaluate the short-term outcomes after liver cancer surgery in patients treated with L-carnitine comparedwith nontreated patients.
Methods: Patients with primary liver malignancies scheduled to undergo a hepatectomy were randomlyassigned to receive either perioperative treatment with L-carnitine (carnitine group) or usual intake (control group). The primaryendpoint of this study was the short-term outcome after liver surgery.
Results: The study participants were randomly assigned into2 groups: 106 patients in the control group and 102 patients in the perioperative L-carnitine supplementation group. The restorationof serum ammonia levels, prothrombin time, and peripheral neutrophil count at 3 days after the operation was significantly fasterin the carnitine group than in the control group. Fewer patients in the carnitine group developed grade B posthepatic liver failure,according to the grading system of the International Study Group of Liver Surgery, than patients in the control group (20% vs76%). The length of hospitalization was significantly shorter in patients in the carnitine group than in those in the control group.
Conclusions: We found that perioperative treatment with L-carnitine was significantly better than ordinary treatment in reducingpostoperative serum ammonia levels, suggesting that L-carnitine may serve as a pivotal regulator of liver injury and repair andresult in shorter postoperative hospitalization +
Publication: L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial +
Purpose
L-carnitine, a popular complementary and alternative medicine product, is used by patients with cancer for the treatment of fatigue, the most commonly reported symptom in this patient population. The purpose of this study was to determine the efficacy of L-carnitine supplementation as a treatment for fatigue in patients with cancer.
Patients and Methods
In this double-blind, placebo-controlled trial, patients with invasive malignancies and fatigue were randomly assigned to either 2 g/d of L-carnitine oral supplementation or matching placebo. The primary end point was the change in average daily fatigue from baseline to week 4 using the Brief Fatigue Inventory (BFI).
Results
Three hundred seventy-six patients were randomly assigned to treatment with L-carnitine supplementation or placebo. L-carnitine supplementation resulted in significant carnitine plasma level increase by week 4. The primary outcome, fatigue, measured using the BFI, improved in both arms compared with baseline (L-carnitine: 0.96, 95% CI, 1.32 to 0.60; placebo: 1.11, 95% CI 1.44 to 0.78). There were no statistically significant differences between arms (P .57). Secondary outcomes, including fatigue measured by the Functional Assessment of Chronic Illness Therapy–Fatigue instrument, depression, and pain, did not show significant difference between arms. A separate analysis of patients who were carnitine-deficient at baseline did not show statistically significant improvement in fatigue or other outcomes after L-carnitine supplementation.
Conclusion
Four weeks of 2g of L-carnitine supplementation did not improve fatigue in patients with invasive malignancies and good performance status. +
Publication: L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study +
Carnitine deficiency is prevalent in populations with chronic illness, including cancer. In a recent open-label study, L-carnitine supplementation was well tolerated and appeared to improve fatigue and other outcomes in cancer patients. To further evaluate this finding, adult patients with advanced cancer, carnitine deficiency (free carnitine more than 35 μmol/L for males or less than 25 μmol/L for females, or acyl/free carnitine ratio of more than 0.4), moderate to severe fatigue, and a Karnofsky Performance Status (KPS) score of 50 or more, were randomly assigned to receive either L-carnitine (0.5 g/day for two days, followed by 1 g/day for two days, and then 2 g/day for 10 days) or placebo. This double-blind phase was followed by an open-label phase, during which all patients received L-carnitine supplementation for two weeks. Outcomes included the fatigue subscale of the Functional Assessment of Cancer Therapy-Anemia (FACT-An), the Linear Analog Scale Assessments (LASA), the Mini-Mental State Exam (MMSE), and the KPS. Twenty-nine patients (12 placebo, 17 L-carnitine) were included in the intent-to-treat (ITT) analysis. From baseline to the end of the double-blind phase, serum total and free L-carnitine increased from 32.9 ± 3.8 to 56.6 ± 20.5 (P = 0.004), and from 22.9 ± 19.4 to 45.3 ± 17.2 (P = 0.004), respectively, in the L-carnitine-treated group, and from 28.2 ± 10.2 to 36.2 ± 8.7 (P = ns), and from 22.6 ± 7.9 to 28.7 ± 8.6 (P = ns) in the placebo group, respectively. The planned ITT analysis revealed no significant improvement in any of the study's endpoints, and these negative findings were not different when data from two patients who did not adhere to the protocol were eliminated. However, an exploratory covariate analysis that excluded these two protocol violators and included outcome data from both the double-blind and open-label phases demonstrated significantly improved fatigue on the FACT-An fatigue subscale (P < 0.03), and significantly improved FACT-An functional well-being subscale (P < 0.03), and KPS (P < 0.003), in the group that started with L-carnitine during the double-blind phase. These data do not support the conclusion that L-carnitine in the doses tested reverses cancer-related fatigue in carnitine-deficient patients. However, L-carnitine supplementation does increase L-carnitine serum levels, and the positive findings in an exploratory analysis justify a larger study to determine if this strategy could be of benefit for a subpopulation of cancer patients.
Publication: L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN) - a randomized multicentre trial +
Background
Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia.
Findings
We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g) or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM) kg. During treatment body-mass-index increased by 3,4 ± 1,4% under L-Carnitine and decreased (−1,5 ± 1,4%) in controls (p < 0,05). Moreover, nutritional status (body cell mass, body fat) and quality-of-life parameters improved under L-Carnitine. There was a trend towards an increased overall survival in the L-Carnitine group (median 519 ± 50 d versus 399 ± 43 d, not significant) and towards a reduced hospital-stay (36 ± 4d versus 41 ± 9d,n.s.).
Conclusion
While these data are preliminary and need confirmation they indicate that patients with pancreatic cancer may have a clinically relevant benefit from the inexpensive and well tolerated oral supplementation of L-Carnitine. +
Publication: Limited effects of selenium in the prevention of radiation-associated toxicities - results of a randomized study in head neck cancer patients +
Objective: The substitution of selenium activates the selenium-dependent enzyme glutathione peroxidase, which is important for scavenging free radicals. To date, only limited data are available about the clinical impact of selenium regarding the toxicities due to free radical producing therapies, e.g. irradiation or chemotherapy, and therefore the objective of this study was to investigate the clinical impact of selenium in such therapies.
Patients and Methods: 39 patients (8 female, 31 male) with advanced head and neck cancer were included in a randomised phase II study. The mean age was 63.52±9.31 years. Tumour localizations: oral cavity 15 patients, oropharynx 19 patients, hypopharynx 5 patients, carcinoma of unknown primary 1 patient. Group A (n=22) received 500 μg sodium selenite on the days of radiotherapy and 300 μg sodium selenite on days without radiotherapy. Group B (17) was irradiated without any selenium substitution. Both groups were well balanced according to age, gender, localization and stage of the tumour. The RTOG grade of radiation-associated toxicities was evaluated once per week.
Results: The following serious toxicities were observed (group A vs. group B): dysphagia 22.7% vs. 35.3%, loss of taste 22.7% vs. 47.1%, dry mouth 22.7% vs. 23.5%, and stomatitis 36.4% vs. 23.5%. A statistical trend (Fisher’s exact test) was only seen for the loss of taste (p=0.172). The weekly patient analysis (Student’s t-test) showed a significant reduction of dysphagia in the selenium group (Group 1) at the last week of irradiation.
Conclusion: This small randomised trial showed limited effects of selenium in the prevention of ageusia (loss of taste) and dysphagia due to radiotherapy of head and neck cancer. +