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 randomly assigned 744 cancer patients to four arms: 1) placebo, 2) 0.5g ginger, 3) 1.0g ginger, or 4) 1.5g 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 (250mg) or placebo twice daily for six days starting three 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 0.5g and 1.0g 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 daily dose of 0.5g-1.0g significantly aids in reduction of the severity of acute chemotherapy-induced nausea in adult cancer patients.

SummaryBackground-Most women receiving systemic therapy for breast cancer experience hot flashes. We undertook a randomised, double-blind, placebo-controlled, multi-institutional trial to assess the efficacy of gabapentin in controlling hot flashes in women with breast cancer.

Fatigue is often related to cancer, and that related to its treatment is the most commonly reported side effect of cancer treatment. It differs from that induced by other causes, such as sleep disturbance and exertion, as the latter are typically alleviated by a period of rest. In contrast to exercise-induced fatigue, the fatigue reported by cancer patients is usually described as an unusual, excessive, whole-body experience that is disproportionate or unrelated to activity or exertion and is not relieved by rest or sleep. Cancer-related fatigue is a subjective experience that has a clear detrimental effect on a cancer patient's quality of life and ability to sustain the usual personal, professional, and social relationships. The fatigue can be pervasive: cancer patients frequently report that fatigue begins with treatment, continues during the course of chemotherapy or radiation treatment, and declines somewhat - but frequently sustains at a higher-than-baseline rate - after treatment is over. It may also persist for several years even in patients with no apparent disease. While a number of researchers have speculated about the nature of cancer-related fatigue, there has been little systematic research on its etiology or treatment. In many aspects our knowledge of the fatigue mechanisms in cancer patients is at a similar stage to that reached in our understanding of anti-cancer therapy-induced nausea and vomiting about 20 years ago. This paper introduces four plausible hypotheses for the development of fatigue. Evidence available to support a role for anemia, adenosine triphosphate, vagal afferents, and the interaction of the HPA/cytokines and 5HT is discussed.

Paroxetine had no influence on fatigue in patients receiving chemotherapy. A possible explanation is that cancer-related fatigue does not involve a reduction in brain 5-HT levels.

Although depression was significantly reduced in the 44 patients receiving paroxetine compared to the 50 patients receiving placebo, indicating that a biologically active dose was used, no significant differences between groups on any of the measures of fatigued were observed. Results suggest that modulation of serotonin may not be a primary mechanism of fatigue related to cancer treatment.

Little is known about the frequency, severity, and course of symptoms experienced by patients receiving radiotherapy (RT). For this descriptive study, 1129 patients with a variety of cancer diagnoses completed a 12-item Symptom Inventory (SI) at the start of RT; 419 of these patients also completed the SI weekly for an additional 4 weeks (five data points). Eighty-four percent of the 1129 patients were already experiencing symptoms when treatment began. All symptoms significantly increased in frequency over a typical 5 week RT course (all Ps<0.001). Skin problems showed the largest increase. The most common symptoms (fatigue, drowsiness, and sleep problems) were also the most severe. Female patients and patients younger than the median age (59 years) reported significantly more symptoms than males and those 59 years or older. Symptom frequency and severity varied significantly by cancer diagnosis. Improved understanding about the time course and dose response of radiation-induced toxicity will permit more accurate presentation of side effect risk at the time patient consent is obtained.

BACKGROUNDPatients often describe fatigue as the most distressing of the symptoms they experienced during their cancer treatment. Fatigue may increase from initial levels experienced during cancer treatment with the addition of radiotherapy (RT).METHODSThree hundred seventy‐two patients completed a Symptom Inventory at the initiation of RT and weekly for 4 weeks thereafter. Descriptive statistics were used to evaluate differences in fatigue at baseline by demographics and diagnosis. Changes over the course of treatment were evaluated by repeated‐measures analysis of variance and Student t tests for paired data. The effect of diagnosis, age, gender, and previous treatment on fatigue was investigated by linear and hierarchical regression.RESULTSFifty‐seven percent of patients reported some degree of fatigue at the initiation of RT. The proportion increased to 76% by Week 3 and then to 78% at Week 5. Eighty‐four percent of patients with initial fatigue remained fatigued throughout the 5‐week course. Of the 160 patients without initial fatigue, 70% subsequently developed it. By Week 5, only 13% of patients had never reported any fatigue. Severity was found to be related to diagnosis, with patients with prostate carcinoma reporting the least severe fatigue and patients with lung, alimentary, and head and neck carcinoma reporting the most severe fatigue. Neither gender, age, nor total dose of RT predicted significant variance in severity.CONCLUSIONSFatigue was a common adverse effect of RT for cancer, reported by more than three‐fourths of patients by the third to fifth weeks of treatment. Cancer diagnosis was the only factor found to be significantly related to variation in fatigue severity. Additional studies should be devised to identify other underlying causes of RT‐related fatigue. Cancer 2005. © 2005 American Cancer Society.

Seventy-eight female breast cancer patients were assessed for fatigue, depression, overall mood, and circadian rhythm at their second and fourth on-study chemotherapy cycles as part of a larger study examining the efficacy of paroxetine in reducing chemotherapy-induced fatigue. The Multidimensional Assessment of Fatigue (MAF), the Fatigue Symptom Checklist (FSCL), the Center for Epidemiologic Studies-Depression [CES-D) questionnaire, the Hamilton Depression Inventory (HDI), and the Profile of Mood States (POMS) were completed by patients at home 7 days after each treatment to assess symptom severity. Circadian rhythm was assessed over a 72-h period with the Mini-Motionlogger Actigraph (Ambulatory Monitoring, Ardsley, NY), starting 6 days after treatment. Daily patterns of sleep and activity were compared across the 3-day period by autocorrelation analyses to calculate a circadian rhythm score for each patient, with higher scores associated with lower disruption. Comparisons of fatigue, depression, and mood with patient circadian rhythm measures taken after the second cycle indicate that all five paper and pencil measures correlated well with the measure of circadian rhythm (all r(partial) <--0.30, all P<0.05). Changes in the fatigue, depression and mood measures from the second on-study treatment to the fourth were significantly correlated with concurrent changes in circadian rhythm (MAF r=-0.31; P=0.04; FSCL r=-0.30; P=0.04; CES-D r=-0.39; P=0.008; HDI r=-0.34; P=0.03; POMS r=-0.40; P=.007). These findings provide evidence that circadian rhythm disruption is involved in the experience of fatigue and depression in cancer patients.