Effects of a ketogenic diet on the quality of life in 16 patients with advanced cancer: A pilot trial

Background

Tumor patients exhibit an increased peripheral demand of fatty acids and protein. Contrarily, tumors utilize glucose as their main source of energy supply. Thus, a diet supplying the cancer patient with sufficient fat and protein for his demands while restricting the carbohydrates (CHO) tumors thrive on, could be a helpful strategy in improving the patients' situation. A ketogenic diet (KD) fulfills these requirements. Therefore, we performed a pilot study to investigate the feasibility of a KD and its influence on the quality of life of patients with advanced metastatic tumors.

Methods

Sixteen patients with advanced metastatic tumors and no conventional therapeutic options participated in the study. The patients were instructed to follow a KD (less than 70 g CHO per day) with normal groceries and were provided with a supply of food additives to mix a protein/fat shake to simplify the 3-month intervention period. Quality of life [assessed by EORTC QLQ-C30 (version 2)], serum and general health parameters were determined at baseline, after every two weeks of follow-up, or after drop out. The effect of dietary change on metabolism was monitored daily by measuring urinary ketone bodies.

Results

One patient did not tolerate the diet and dropped out within 3 days. Among those who tolerated the diet, two patients died early, one stopped after 2 weeks due to personal reasons, one felt unable to stick to the diet after 4 weeks, one stopped after 6 and two stopped after 7 and 8 weeks due to progress of the disease, one had to discontinue after 6 weeks to resume chemotherapy and five completed the 3 month intervention period. These five and the one who resumed chemotherapy after 6 weeks report an improved emotional functioning and less insomnia, while several other parameters of quality of life remained stable or worsened, reflecting their very advanced disease. Except for temporary constipation and fatigue, we found no severe adverse side effects, especially no changes in cholesterol or blood lipids.

Conclusions

These pilot data suggest that a KD is suitable for even advanced cancer patients. It has no severe side effects and might improve aspects of quality of life and blood parameters in some patients with advanced metastatic tumors.     

Telephone counseling promotes dietary change in healthy adults: results of a pilot trial

Telephone counseling is increasingly reported to be an effective behavior change strategy, but more studies in broader populations are needed. This uncontrolled pilot trial investigated whether a 3-month/eight-call telephone counseling intervention could promote dietary changes associated with reduced chronic disease risk in adults consuming <5.0 servings of vegetables and fruits daily. Between 2002 and 2004, 97 adults (mean age 46 years; range 21 to 84 years) completed the intervention and a follow-up assessment at 6 months. Approximately half were of nonwhite ethnicity (53%). The majority were women (95%) and had never had cancer (89%). The intervention promoted daily intakes of three to five vegetable servings, two to four fruit servings, and three whole-grain and/or beans/legumes servings. Average total daily intake of vegetables, fruits, whole grains, beans/legumes, fiber, and fat were assessed at baseline and at 6 months, each by a set of three 24-hour recalls. Plasma carotenoids were measured on a subsample (n=41) as an objective biomarker of vegetable and fruit intake. Change in mean self-reported dietary intake (ie, vegetables, fruit, whole grains, beans/legumes, fiber, and fat) and plasma carotenoids were compared by paired t tests. The intervention was associated with a significant (P<0.001) increase in vegetable servings per day (baseline 2.1 servings per day, 6 months 3.5 servings per day; 67% increase), fruit servings per day (baseline 1.4 servings per day, 6 months 2.4 servings per day; 71% increase), and whole-grain and/or bean servings per day (baseline 1.0 serving per day, 6 months 1.4 servings per day; 40% increase). These changes were corroborated by a significant (P<0.001) increase in total plasma carotenoids. This 3-month/eight-call telephone counseling intervention was associated with dietary change in healthy adults consuming fewer than five servings per day of vegetables and fruit at study entry.     

Influence of a nutritional intervention on dietary intake and quality of life in cancer patients: A randomized controlled trial

ObjectiveWeight loss is common in patients with malignant tumors and it can adversely affect quality of life and survival. The aim of the present study was to investigate the effects of a nutritional intervention in cancer patients in an outpatient setting.MethodsCancer outpatients (N = 58) who were classified as undernourished or at high risk for undernutrition by the Nutritional Risk Screening 2002 tool were randomized into two groups. One group (n = 30) received standardized individual nutritional therapy, including counseling by a dietitian, food fortification, and oral nutritional supplements if required. The second group (n = 28) received standard care. The nutritional intervention lasted 3 mo. Dietary intake (3-d dietary record), nutritional status (body weight), physical functioning (performance status, hand-grip strength) and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0) were assessed at baseline and after 6 wk and 3 mo. An additional follow-up assessment was carried out 3 mo post-intervention.ResultsNutritional intervention led to a significantly higher average energy and protein intake in the nutritional therapy group (+379 kcal; 95% confidence interval [CI], 117–642; P = 0.007, respectively; +10.4 g; 95% CI, 2.3–18.5; P = 0.016). However, the increased dietary intake was not associated with improvements in nutritional status, physical functioning, or quality of life.ConclusionsIndividual nutritional counseling significantly and positively influenced energy and protein intake, but did not improve nutritional or physical outcome or quality of life. These results indicate that nutritional therapy alone is of limited efficacy in cancer patients whose nutritional status has already deteriorated.     

A best practice dietetic service for rural patients with cancer undergoing chemotherapy: A pilot of a pseudo-randomised controlled trial

Aim:  The aim of the present study was to test a predetermined model of best practice for rural patients with cancer undergoing chemotherapy treatment by assessing patient satisfaction and patient outcomes.
Methods:  The study design was a pseudo-randomised controlled trial, comparing a predetermined best practice protocol with usual service delivery, as provided by the local hospital. Patient outcomes were measured using the Patient-Generated Subjective Global Assessment (PG-SGA), Modified Constipation Assessment Scale (MCAS) and Global Quality of Life questionnaire C30 (QLQ-C30). Patient satisfaction and feedback were also assessed.
Results:  Twenty-four cancer patients receiving chemotherapy treatment in a rural oncology treatment centre were recruited to the study, with complete data sets for 12 participants. The median age of participants was 60 years (range 41–74), with equal numbers of male and female participants. No statistically significant results were found for any of the outcome variables. More than half of all the service delivery provided to the intervention group was outside the designated clinic times, with services provided most days of the week. The preferred method of review for respondents was by telephone or in person at the time of treatment.
Conclusions:  This pilot study indicates the need to further investigate this best practice dietetic service model to determine if patient outcomes are significant. Patient feedback indicates that a rural dietetic service to oncology patients needs to be well organised with a screening process and provided in a timely and flexible way.     

Impact of fish oil and melatonin on cachexia in patients with advanced gastrointestinal cancer: a randomized pilot study

OBJECTIVE: The effect of fish oil (FO), melatonin (MLT), or their combination and dietary advice on cachexia and biochemistry variables reflecting cachexia were investigated in patients with advanced gastrointestinal cancer. METHODS: Twenty-four patients not amenable to standard anticancer treatment and with documented weight loss and/or decreased serum albumin were included. They were randomized to 30 mL/d of FO, which provided 4.9 g of eicosapentaenoic acid and 3.2 g of docosahexanoic acid, or 18 mg/d of MLT for 4 wk. During the next 4 wk, all patients had FO and MLT. Serum or plasma was analyzed for tumor necrosis factor-alpha, interleukin-1beta, soluble interleukin-2 receptor, interleukin-6, and interleukin-8 and the fatty acids eicosapentaenoic acid, docosahexanoic acid, arachidonic acid, and linoleic acid. RESULTS: Serum levels of eicosapentaenoic acid and docosahexanoic acid increased as expected with FO. No major changes in biochemical variables and cytokines were observed with any intervention. In the FO group, 5 of 13 patients (38%) showed weight stabilization or gain compared with 3 of 11 patients (27%) in the MLT group. After combining interventions, approximately 63% of patients showed such responses. CONCLUSIONS: FO, MLT, or their combination did not induce major biochemical changes indicative of a strong anticachectic effect. Nonetheless, the interventions used may have produced a weight-stabilizing effect.     

Leuprorelin: a leading role in advanced prostate cancer therapy

Leuprorelin is a luteinizing hormone-releasing hormone analogue, licensed in the UK for the treatment of advanced prostate cancer. This review highlights the efficacy and tolerance of this agent and the benefits provided for developing patient-centred therapy and optimizing patient quality of life.     

Effects and feasibility of a multi-disciplinary orientation program for newly registered cancer patients: design of a randomised controlled trial

Background  

Diagnosis and treatment of cancer can contribute to psychological distress and anxiety amongst patients. Evidence indicates that information giving can be beneficial in reducing patient anxiety, so oncology specific information may have a major impact on this patient group. This study investigates the effects of an orientation program on levels of anxiety and self-efficacy amongst newly registered cancer patients who are about to undergo chemotherapy and/or radiation therapy in the cancer care centre of a large tertiary Australian hospital.     

Methylphenidate for fatigue in advanced cancer: a prospective open-label pilot study.

Psychostimulants such as methylphenidate are used for fatigue in cancer patients. We report a prospective, open-label, pilot study of the successful use of methylphenidate to treat fatigue in nine of 11 consecutive patients with advanced cancer. Seven had received radiation or chemotherapy, a median of three weeks (range from one to 30 weeks) prior to methylphenidate. A rapid onset of benefit was noted, even in the presence of mild anemia. Sedation and pain also improved in some. Only one patient had side effects severe enough to stop the medication.     

Dietary patterns in patients with advanced cancer: implications for anorexia-cachexia therapy

BACKGROUND: Severe malnutrition and wasting are considered hallmarks of advanced malignant disease, and clinical research into anorexia-cachexia therapy and nutritional support for cancer patients is ongoing. However, information on typical dietary intakes and food choices for this population is notably lacking; proposed therapies for anorexia and wasting are not framed within the context of current intake. OBJECTIVE: The objective of the study was to characterize the food intake patterns of patients with advanced cancer. DESIGN: Patients with advanced cancer (n = 151) recruited from a regional cancer center and palliative-care program completed a 3-d dietary record a mean (+/-SD) 8 +/- 7 mo before death. Food items were categorized according to macronutrient content and dietary use and subsequently entered into cluster analysis. RESULTS: Wide variations in intakes of energy (range: 4-53 kcal . kg body wt(-1) . d(-1); x +/- SD: 25.1 +/- 10.0 kcal . kg body wt(-1) . d(-1)) and protein (range: 0.2-2.7 g . kg body wt(-1) . d(-1); x +/- SD: 1.0 +/- 0.4 g . kg body wt(-1) . d(-1)) were observed. Even the subjects with the highest intakes had a recent history of weight loss, which suggests that the diets of those persons were consistently inadequate for weight maintenance. Cluster analysis found 3 dietary patterns that differed in food choice and caloric intake. Low intakes and a high risk of weight loss were associated with decreased frequency of eating and dietary profiles with little variety and unusually high proportions of liquids. CONCLUSION: These data provide a glimpse into dietary habits toward the end of life. Unique dietary patterns were found in this nutritionally vulnerable patient population.     

A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study

Background

The study was conducted to test the feasibility of conducting a randomized controlled contraceptive trial in postpartum teens and to assess whether postpartum advanced supply of emergency contraception (EC) to teenaged mothers helps to prevent repeat pregnancies of close proximity.

Study Design

We performed a randomized controlled trial of 50 postpartum teens at an urban academic medical center. Participants in the intervention arm received routine postpartum contraceptive care and advanced supply of one pack of EC pills with unlimited supply thereafter upon request. The routine care arm (RCA) received routine postpartum contraceptive care. We asked open-ended questions about how we might maximize study retention and implemented the participants' requests in both arms.

Results

Our retention rate was 78%. There were three (13%) pregnancies out of 23 participants in the intervention arm and eight (30%) pregnancies out of 27 participants in the RCA. The risk of pregnancy occurring in the intervention arm was 0.57 times that of the RCA (95% CI 0.20-1.60; p=.23).

Conclusions

A randomized controlled trial of postpartum teens to receive and not to receive advanced supply of EC is both feasible and necessary. Our study provides preliminary data to suggest that advanced supply of EC may help decrease repeat teen pregnancies.     

Preoperative chemoradiotherapy for locally advanced low rectal cancer using intensity-modulated radiotherapy to spare the intestines: a single-institutional pilot trial

The irradiated volume of intestines is associated with gastrointestinal toxicity in preoperative chemoradiotherapy for rectal cancer. The current trial prospectively explored how much of the irradiated volume of intestines was reduced by intensity-modulated radiotherapy (IMRT) compared with 3-dimensional conformal radiotherapy (3DCRT) and whether IMRT might alleviate the acute gastrointestinal toxicity in this population. The treatment protocol encompassed preoperative chemoradiotherapy using IMRT plus surgery for patients with clinical T3–4, N0–2 low rectal cancer. IMRT delivered 45 Gy per 25 fractions for gross tumors, mesorectal and lateral lymph nodal regions, and tried to reduce the volume of intestines receiving 15 Gy (V_{15 Gy}) < 120 cc and V_{45 Gy} ≤ 0 cc, respectively, while keeping target coverage. S-1 and irinotecan were concurrently administered. Acute gastrointestinal toxicity, rates of clinical downstaging, sphincter preservation, local regional control (LRC) and overall survival (OS) were evaluated. Twelve enrolled patients completed the chemoradiotherapy protocol. The volumes of intestines receiving medium to high doses were reduced by the current IMRT protocol compared to 3DCRT; however, the predefined constraint of V_{15 Gy} was met only in three patients. The rate of ≥ grade 2 gastrointestinal toxicity excluding anorectal symptoms was 17%. The rates of clinical downstaging, sphincter preservation, three-year LRC and OS were 75%, 92%, 92% and 92%, respectively. In conclusion, preoperative chemoradiotherapy using IMRT for this population might alleviate acute gastrointestinal toxicity, achieving high LRC and sphincter preservation; although further advancement is required to reduce the irradiated volume of intestines, especially those receiving low doses.