To determine if maintenance acupuncture is beneficial in sustaining improvements in fatigue after a course of acupuncture.

Patients in a previous six-week acupuncture trial were rerandomized to three groups:  maintenance self-acupuncture, therapist-delivered maintenance acupuncture, or a control group receiving usual care. Maintenance therapy lasted for four weeks. Standard acupuncture points were used, and sessions were weekly. Data were collected at the end of four weeks and at 12 weeks after rerandomization.

• The study reported a sample of 151 women with breast cancer.
• Mean age was 53 years.
• Patients had undergone surgery, and the majority had received prior chemotherapy and radiotherapy.
• Mean time since completion of treatment was 20 months.
• The majority of patients were married and employed full- or part-time.

• Single site
• Multiple settings
• United Kingdom

Patients were undergoing the transition phase of care after active treatment.

The study was a randomized, controlled trial.

• Multidimensional Fatigue Inventory (MFI)
• Hospital Anxiety and Depression Scale (HADS)
• Functional Assessment of Cancer Therapy-Breast (FACT-B)
• Patients' logs of self-needling

Results showed a trend of fatigue improvement in the combined acupuncture groups compared to the control; the trend was not significant. In regard to results reflecting anxiety or depression, the study showed no differences between groups. Patients' logs indicated that patients performed self-needling as planned.

Findings suggested that it is feasible for patients to maintain acupuncture treatment through self-needling. Compared to symptom improvement in patients in the control group, symptom improvement in patients undergoing maintenance acupuncture through self-needling or through delivery by a therapist was not significant.

• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• The authors did not discuss other treatments or interventions aimed at fatigue. If the authors used additional management approaches, the approaches are unknown.

The study showed that patients can be taught to deliver their own acupuncture treatments effectively by self-needling. The study did not demonstrate that ongoing acupuncture, or maintenance acupuncture, had any effect on fatigue, anxiety, or depression.

To assess the effectiveness of acupuncture for cancer-related fatigue (CRF) in women with breast cancer.

Women were randomly assigned to acupuncture or enhanced usual care groups. Usual care enhancement consisted of providing a booklet about CRF, diet, exercise, and sleep. The intervention group was offered six acupuncture treatments over six weeks. Sessions lasted 20 minutes each and involved unilateral or bilateral needles at three points. No rotation or flicking of needles was performed. Patients were followed for 18 weeks. Outcome measures were recorded at six weeks.

• The sample was comprised of 246 participants.
• Mean age was 52.5 years (range 25–80).
• All participants were female.
• All participants had breast cancer with no distant metastases. 
• All participants had completed antitumor treatment within one month to five years prior to enrollment. 
• All participants had a baseline fatigue of at least 5 on an 11-point screening scale. 
• Average time since diagnosis was 20.5 months.
• Mean duration of fatigue was 16.5 months.
• Participants were predominantly white, married, and had at least a college education.

• Multisite
• Outpatient
• United Kingdom

The study has clinical applicability for late effects and survivorship.

The study was a randomized, controlled trial.

• Multidimensional Fatigue Inventory (MFI)
• Hospital Anxiety and Depression Scale (HADS)
• Functional Assessment of Cancer Therapy-Breast (FACT-B)
   

The difference score between the control and acupuncture groups for fatigue was –3.11 (95% confidence interval [CI] [–3.97, –2.25]; p < 0.001). Intention-to-treat (ITT) analysis, using an assumption of no improvement for patients whose week six outcome data were missing, continued to show a significant difference (–2.49; p < 0.001). Week six outcomes, as reflected in HADS and FACT-B scores, were significantly improved from baseline in patients who received acupuncture (p < 0.001).

Findings showed that acupuncture as provided was effective in reducing fatigue over a six-week period among survivors of breast cancer.

• The study had a risk of bias due to no blinding.
• Data were missing for 20.3% of the acupuncture group and 13.3% of the control group. The authors performed conservative ITT analysis to account for the missing data. For the intervention group, the authors reported complete data only.
• The authors did not discuss data relative to anxiety or depression.

Findings showed that acupuncture was helpful in reducing fatigue in patients with breast cancer who had completed antitumor treatment. The study supports the effectiveness of acupuncture for the treatment of fatigue.

The study was a randomized, controlled trial of acupuncture (n = 15); acupressure (n = 16); and sham acupressure (n = 16). Acupuncture included six 20-minute sessions over two weeks. Acupressure involved self-applying pressure to the same points daily. Sham acupressure involved self-applying pressure to nonenergy points. The selected acupuncture points were energy points that have been used for more than 2,000 years.

• The study included 47 patients with cancer who experienced moderate to severe fatigue (greater than 5 on a 1–10 scale) who were at least one month postchemotherapy.
• Of the participants, 32 of 47 were female and all but one were Caucasian.
• Mean age was 53.4 years (range 20–76).
• Patients were excluded if they had needle phobia, platelets less than 50,000, hematocrit (HCT) less than 30, Karnofsky Performance Status (KPS) less than 70, or were on steroids.

Patients were recruited from an outpatient clinic, an acupuncture treatment setting in a hospital in the United Kingdom, or in their own homes.

The study was a small randomized, controlled trial with blinding between two acupressure conditions.

• Multidimensional Fatigue Inventory (MFI) pretreatment and at two and four weeks
• Daily log for acupressure groups

The study included an intention-to-treat (ITT) analysis. Significant improvements existed in general fatigue (p < 0.001), physical fatigue (p = 0.016), activity (p = 0.004), and motivation (p = 0.024). Patients showed 36% improvement in acupuncture, 19% in acupressure, and 0.6% in sham acupressure. The effect was not sustained at the same level after two weeks.

• The drop-out rate was 15%.
• It was not possible to blind the acupuncture group.
• Travel to the clinical site to receive acupuncture or acupressure treatment was a barrier.

Spot bleeding was observed in two cases. Trained acupuncturists are necessary. A detailed description of acupuncture was given using Standards of Reporting Interventons of Controlled Trials of Acupuncture (STRICTA) guidelines.

• N = 1,014 (HEC), 848 (MEC)
• MEAN AGE = 58–59 years (Study 1 HEC, SD = 12 years), 53–54 years (Study 2 HEC, SD = 13–14 years). Demographic results of the HEC studies were reported. Data only about females participants were reported.  
• MALES: Study I = 62%, Study II = 61% (both for HEC studies), FEMALES: Study 1 = 38%, Study 2 = 39%. All results are related to the HEC studies.
• KEY DISEASE CHARACTERISTICS: Respiratory, urogenital, and others (not specified)

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: Not specified

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care 

Phase III clinical trial program; included data from two HEC trials and one MEC trial

• Modified version of the Functional Living Index–Emesis (FLIE)

More patients who received the aprepitant regimen in the HEC trials achieved overall complete response compared with those on standard antiemetic therapy in cycle one adjusted for gender, region, and use of concomitant chemotherapy (67.7% versus 47.8%, p < 0.01). A significantly higher number of patients who received aprepitant reported NIDL (74.4%) as compared with those on the standard antiemetic regimen (63.9%, p < 0.01). In the HEC group, when compared to standard therapy, patients who received aprepitant reported significantly lower nausea (70.2% versus 60.9%) and vomiting (84.6% versus 68.7%, p < 0.01). In the MEC trial, reports of no emesis were significantly lower in the aprepitant group (76.2%) than in the standard regimen (61.1%, p < 0.001) after the first cycle of chemotherapy. Patients receiving aprepitant in the MEC trial had a significantly higher percentage of complete response (68.7%) than the patients in the standard regimen (56.3%, p < 0.001). Aprepitant also had a significant impact on patient report of NIDL with 73.4% reporting no impact compared to 66.3% in the standard regimen group (p < 0.05).

Aprepitant, when given with HEC, led to higher overall complete response rates than the standard regimen. Patients who received aprepitant and MEC also reported lower levels of nausea and vomiting. For patients receiving both HEC and MEC, aprepitant improved outcomes on activities of daily living (ADL).

• Patients may not be able to detect the effect of chemotherapy on their daily function.
• Recall bias could be considered as a limitation.

Aprepitant, in addition to standard CINV prophylactic medications, reduces nausea and vomiting associated with chemotherapy and decreases the impact of CINV on ADLs. This is true for patients receiving HEC and MEC. Nurses should spend time educating patients on how CINV can impact ADLs and work with patients to create patient-centered, nurse-led interventions to ease the influence of CINV on patient quality of life.

To assess the effectiveness of progressive muscle relaxation (PMR) and guided imagery training as an adjuvant intervention and accompanying antiemetics (metoclopramide, dexamethasone) in managing acute and delayed nausea and vomiting, anxiety, and depression

In the experimental group, PMR was initiated for 25 minutes and guided imagery for 5 minutes, each one hour before chemotherapy was administered.

The study reported on 71 Chinese chemotherapy-naive women with breast cancer who were older than 30 years and were receiving doxorubicin and cyclophosphamide.

The study was conducted at a university hospital outpatient treatment center in Hong Kong.

This was a randomized, controlled clinical trial.

The Profile of Mood States, State-Trait Anxiety Index, and Morrow Assessment of Nausea and Vomiting were translated into Chinese and back-translated. Measures were piloted on 25 patients prior to use in the study. Demographic data and vital signs measures were used.

The effects of PMR therapy and guided imagery were more pronounced at the initial stage of treatment when patients did not know what to expect. The effects were reduced on the fourth day and beyond. The study did not show a significant reduction in the intensity of nausea and vomiting after chemotherapy; the baseline nausea and vomiting values showed that the patients in this study began with considerably lower levels of nausea and vomiting than in previous studies. The combination of PMR and guided imagery was beneficial for cognitive distraction and relaxation, components that reduce stress and anxiety. The physiologic benefit to these techniques was discussed. Differences in Chinese and Western cultures related to expression of emotions was noted.

PMR therapy with guided imagery was found to be superior to standard antiemetic treatment alone in managing acute and delayed chemotherapy-induced nausea and vomiting.

• Pharmacologic agents prescribed were metoclopramide and dexamethasone for doxorubicin and cyclophosphamide treatment; 5-HT₃ was not given despite publication in 2002.
• Only one population (Chinese) was included.

To study the effects of P6 acupressure in the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer.

Participants were randomized to the control or experimental arm and received standard antiemetics before chemotherapy with prescriptions for antiemetics for delayed CINV that were variable.

For the experimental group, acupressure was applied using a Sea-Band® (Sea-Band Ltd.) for five days after chemotherapy administration. Researchers taught patients how to wear the bands bilaterally with the stud pressing the P6 acupoint in brief education sessions. Patients were given daily logs with the hours of the day and asked to put a mark at the hour each time that they pressed the wristband’s stud. Patients were instructed to press the stud for two to three minutes every two hours throughout the day, marking it in their log.

The control group was given antiemetics and told that they would receive acupressure instructions and wristbands with their next cycle of chemotherapy.

All participants completed questionnaires every evening after chemotherapy for five evenings. Completed questionnaires were returned directly to researchers or via pre-paid envelopes.

• The study consisted of 36 participants.
• All patients were newly diagnosed and chemotherapy naïve, starting their first cycle of chemotherapy for breast cancer, stages I-III, receiving doxorubicin or epirubicin and cyclophosphamide.
• Patients were excluded if they had received palliative chemotherapy, had a life expectancy of less than three months, had bowel obstruction, were receiving radiation therapy, or had lymphedema.

This study was conducted at a general hospital and a cancer hospital in the United Kingdom.

This was a randomized, controlled trial.

The Rhodes Index of Nausea and Vomiting was used.

Nausea and retching experience and nausea, vomiting, and retching occurrence and distress were significantly lower in the acupressure group than the control group.

At day 3, the acupressure group had a high level of nausea, vomiting, and retching, which was equal to the control group.

Acupressure at P6 is an effective intervention for managing CINV in patients with breast cancer.

• The sample size was small.
• Antiemetics for days 2-5 were not controlled.
• The study relied on patients completing daily questionnaires and returning them.

Use of the acupressure bands is easy to teach, and the bands are low in cost.

To determine the effectiveness of self-acupressure using wrist bands in the management of acute and delayed chemotherapy-induced nausea and vomiting (CINV) and to assess if the wrist bands are more effective in high, moderate, or low emetogenic chemotherapies

Patients were randomized using a method of minimization with a random element. Randomization was balanced for gender, age, and levels of emetogenic chemotherapy. Both patients and treating physicians were blinded to group. Patients received an acupressure wrist band, a sham acupressure wrist band, or no wrist band. All patients received the standard antiemetic regimen based on American Society of Clinical Oncology (ASCO) and Multinational Association of Supportive Care in Cancer (MASCC) guidelines with the exception of NK1-receptor antagonists, which were not available. The acupressure wrist bands are elastic with a 1 cm round plastic button. The button was worn at the P6 acupoint after patients were trained on the appropriate location to wear the button. The sham wrist bands had the button on the outside of the elastic band, and the button was worn facing away from the P6 point. Patients wore the wrist bands beginning the morning before chemotherapy and for six days after each cycle. Main outcome data were collected at baseline the day before chemotherapy and daily for up to seven days after chemotherapy, and additional data were collected on day 10. Some patients also participated in a qualitative interview.

• N = 361  
• AGE = Unable to determine
• MALES: 31.5%, FEMALES: 68.5%
• KEY DISEASE CHARACTERISTICS: Heterogeneous

• SITE: Multi-site    
• SETTING TYPE: Outpatient   
• LOCATION: United Kingdom

• PHASE OF CARE: Active antitumor treatment

Randomized, three-group, sham-controlled trial (Phase III)

• Rhodes Index of Nausea, Vomiting and Retching (INVR)
• MASCC Antiemesis Tool
• European Quality of Life-5 Dimensions (EQ-5D) utility scale
• Functional Assessment of Cancer Therapy—general quality of life scale
• Baseline measures—anxiety and depression, nausea/vomiting expectations, expectations from using the acupressure wrist bands

After the first cycle, there was no difference in the nausea level between any group, though there was a trend towards lower nausea scores for both the wrist band and sham wrist band groups. Qualitative interviews indicate that patients perceived both real and sham wrist bands as helpful in managing CINV.

Acupressure wrist bands are not an effective intervention in the management of CINV.

• Subject withdrawals ≥ 10%  
• Other limitations/explanation: 500 patients were randomized and data were only used on 361.

Nurses can educate patients that acupressure wrist bands are not an effective intervention to manage CINV.

To determine the effectiveness of acupressure in the management of chemotherapy-induced nausea and vomiting (CINV)

Patients were randomly assigned to one of three groups: use of P6 acupressure wristband, sham acupressure wristband, or usual care only. 

Prior to randomization, subjects were stratified by age group, gender, and emetogenicity of planned chemotherapy.  Patients were instructed to wear wristbands on both arms from the morning before chemotherapy administration and for the following 6 days, and to only remove them for showering or bathing. 

All patients received antiemetics based on American Society of Clinical Oncology (ASCO) and Multinational Association of Supportive Care in Cancer (MASCC) guidelines with the exception that NK1 receptor antagonists were not used with highly emetogenic chemotherapy, as these were not widely available in the country. 

All patients had rescue antiemetics available.  Study questionnaires were completed on day 10 of each cycle. Patients graded nausea daily.

• The study consisted of 372 patients.
• Two-thirds of the patients were over age 50. The sample included a few children. No other data was available.
• The majority (77.2%) of patients were female.
• A variety of tumor types and regimens were represented, with breast cancer as the most frequent.
• The majority of patients were receiving moderately emetogenic treatments.
• Almost all patients were Caucasian.

The study was conducted at multiple outpatient sites in the United Kingdom.

All patients were in active antitumor treatment.

This was a randomized controlled trial.

Measurement tools used were

• Rhodes Index of Nausea Vomiting and Retching
• MASCC Antiemesis Tool
• Functional Assessment of Cancer Therapy (FACT)-General
• The Hospital Anxiety and Depression Scale
• Patient expectations of nausea/vomiting, a two item, 11-point scale.

• The entire group showed relatively low levels of nausea. No significant differences were found between the three study groups in the experiences and measures of nausea; some improvement was found in both the actual and sham intervention groups. 
• The sham acupressure group had better odds ratio in improving nausea than the acupressure group. 
• No differences were found between groups in MASCC tool results for either acute or delayed nausea. 
• No differences were found in other outcome measures.
• Auditing of wristband use showed that compliance was good, with only four cases observed where use was incorrect. 
• Regression analysis showed that older age and male gender were predictive of better nausea outcomes (p = 0.005).

P6 acupressure was not shown to have a significant impact on prevention of CINV.  Findings suggest a potential placebo effect with both acupressure and sham acupressure wristbands.

• This study had unintended interventions or applicable interventions not described that would influence results.
• Participant withdrawals were 10% or more.
• No information about the use of any rescue medication was provided. 
• This study had very low nausea levels.

Findings did not show a significant effect of P6 acupressure on CINV; however, use of an actual and sham acupressure wristband may have a placebo effect.

To determine the feasibility and impact of providing a family-oriented intervention incorporating Hawaiian values on native Hawaiian women with cancer

Recruited patients were randomly assigned to an intervention or control group. The intervention group received sessions of informational and emotional support that incorporated prayer (often done by an elder), participant and staff disclosure of genealogies to affirm spiritual origins, and use of other cultural value items, such as graphics incorporating Hawaiian themes, plant fiber bags for program materials, and sharing of food. Sessions were focused on providing information on cancer basics and understanding of treatment and side effects, as well as information seeking and communication. Sessions included one or two patient-selected family members together. The intervention group had six sessions provided in a variety of locations, including homes, business offices, and libraries. Control group patients received two visits from the research team over three months and were provided with educational brochures and opportunity for having questions answered. Interventions were provided by master’s-prepared social workers.

• The sample included 12 participants.
• Mean age of patients was 55 years (intervention group range was 25–76 years; control group range was 48–84 years).
• Mean age of family members was 54 years.
• Patients were 100% female, and family members were 50% male.
• Patients had a variety of cancer types, including breast, ovarian, throat, uterine, lung, and lymphoma.
• Family members were primarily spouses and adult children.

Hawaii

A randomized prospective trial design was used.

• Cancer knowledge assessment (author developed)
• 12-item self-efficacy scale (author developed) (α = 0.91)
• Family Crisis-Oriented Personal Evaluation Scale (F-COPES)
• Brief Symptom Inventory (BSI)

In the intervention group, women showed significant improvement in F-COPES and decrease in BSI scores (p < 0.05). Family members also reported significant increase in self efficacy (p < 0.01) and F-COPES scores (p < 0.01). Women in the control group did not show change on any indicators, and their family members showed significantly poorer F-COPES total scores (p < 0.05).

Provision of a culturally relevant support intervention appeared to have a positive effect on Hawaiian patients and family members coping with cancer.

• The sample was small, with less than 30 participants.
• No specific diagnostic or symptom information was provided. Differences in these between groups can be expected to have substantial influence on outcomes of interest in this study.
• No demographic information was provided.
• No information regarding the stage of disease or phase of care was provided, another set of items that can be expected to influence outcomes.
• There was no appropriate attentional control, as control subjects received much less intervention time and content than the intervention group.

This study points to the need to consider provision of supportive interventions that are designed according to specific cultural values of participants. This particular study has a number of methodologic and reporting issues that limit the usefulness of findings.

To evaluate the use of Chinese herbal medicine as a complementary therapy for the reducing chemotherapy-induced toxicity

Patients were randomly assigned to one of three Chinese herbalists who evaluated and prescribed combination, single-item, packaged, herbal extract granules. Herbalists completed university training and were licensed to practice Chinese herbal medicine (CHM) in Hong Kong and China. Patients were randomly assigned to each group and received either CHM or placebo packages with corresponding serial numbers in a 14-day supply at each clinic visit. The placebo package contained nontherapeutic herbs with an artificial smell and taste similar to typical herb tea. Each patient completed the log for each day’s consumption. On days 1 and 14, patients met with the herbalist in the clinic setting for evaluation and the herbalist documented the visit in case report form. A quality-of-life questionnaire was completed at baseline, day 1 of each cycle, and after four months.

The sample consisted of 120 patients with early-stage breast and colon cancer receiving adjuvant treatment in a university-based cancer center in Hong Kong.

Patients were included in the study if they

• Were 18 years or older
• Had an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2
• Had no prior chemotherapy
• Had normal hematologic, liver, and renal function.

Patients were excluded from the study if they

• Required concurrent radiotherapy
• Were unable to take or follow directions for daily oral medications
• Had evidence of distant metastasis
• Had concurrent medical illness
• Had received prior chemotherapy
• Were pregnant or breast feeding.

The study was conducted at a university-based cancer center in Hong Kong.

This was a double-blind, placebo-controlled, randomized study.

The National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0 and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 were used.

Patients recorded their daily intake of the herbal package contents on patient logs. Herbalists documented patient visits in case report form 

• CHM was not found to be efficacious for reducing hematologic toxicity associated with adjuvant chemotherapy for breast and colon cancer.
• CHM did reduce grade 2 nausea in the CHM group compared to the placebo group.
• Accrual to the study was slow because patients had a preference for receiving the true CHM rather than participating in a controlled, placebo trial. Therefore, a formal interim analysis was conducted with only half of the target accrual. The review committee eventually terminated the study. 

• Patient accrual was difficult because the population believed CHM to be effective.
• Cost and storage is a barrier with the herbal or natural product granules.
• More than 225 different types of preparations are available.
• CHM requires use of trained and certified herbalists.