A Randomized Controlled Trial Testing the Effects of an Acupressure Intervention on Appetite and Weight in Patients With Gastric, Esophageal, and Pancreatic Cancer: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Accrual (feasibility)
研究概览
简要总结
This clinical trial evaluates the feasibility and acceptability of acupressure to the ear (auricular) to address appetite and weight in patients with stage II-IV gastric, esophageal, or pancreatic cancer. Cancer anorexia, the abnormal loss of appetite, directly leads to cancer-associated weight loss (cachexia) through malnourishment, reduced caloric intake, treatment side-effects, and other modifiable risk factors. Cachexia prolongs length of hospital stay for patients, negatively impacts treatment tolerance and adherence, and reduces overall patient quality of life. Auricular acupressure is a form of micro-acupuncture that exerts its effect by stimulating the central nervous system using adhesive taped pellets applied to specific locations on the external ear. The use of these pellets to deliver auricular acupressure has been shown to improve pain, fatigue, insomnia, nausea and vomiting, depression, and quality of life in both cancer and non-cancer settings. Auricular acupressure is a safe, inexpensive, and non-invasive approach to addressing cancer-related symptoms and treatment side-effects and may be effective at improving appetite and weight loss in stage II-IV gastric, esophageal, and pancreatic cancer patients.
详细描述
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
ARM II: Patients receive usual care on study. Patients also undergo collection of blood samples on study.
After completion of study treatment, patients in Arm II are followed up at 8 weeks after active treatment ends.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •Stage II-IV gastric, esophageal, or pancreatic cancer
- •Appetite score on visual analog scale ≤ 70/100
- •At least 60 days of planned systemic treatment, whether already initiated or scheduled to be initiated
- •Access to phone and electronic device for study contacts and questionnaires
- •Willing and able to attend 4 in-person auricular acupressure treatments at the Fred Hutch South Lake Union Clinic
- •Willing and able to perform 4 at-home self-applied treatments of auricular acupressure
- •Participants must not have received acupressure or acupuncture for low appetite within last 30 days
- •Participants must not be actively using corticosteroids, mirtazapine (Remeron), olanzapine (Zyprexa), or Marinol for appetite stimulation at baseline
- •Participants must be able to intake food orally and not require sole or supplemental intravenous nutrition at baseline
- •Participants must not have a history of physiological eating disorders (e.g., anorexia nervosa) in the last 3 years
- •Participants must not have a current known or diagnosed immunodeficiency
- •Participants must have an intact auricular pinna
- •Able to understand and willing to sign written informed consent in English
排除标准
- 未提供
研究组 & 干预措施
Arm I (acupressure therapy)
Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
干预措施: Acupressure Therapy (Procedure)
Arm I (acupressure therapy)
Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
干预措施: Biospecimen Collection (Procedure)
Arm I (acupressure therapy)
Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
干预措施: Questionnaire Administration (Other)
Arm II (usual care)
Patients receive usual care on study. Patients also undergo collection of blood samples on study.
干预措施: Best Practice (Other)
Arm II (usual care)
Patients receive usual care on study. Patients also undergo collection of blood samples on study.
干预措施: Biospecimen Collection (Procedure)
Arm I (acupressure therapy)
Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
干预措施: Best Practice (Other)
Arm II (usual care)
Patients receive usual care on study. Patients also undergo collection of blood samples on study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Accrual (feasibility)
时间窗: Up to 15 months
Accrual will be measured by the average rate of participants-per-month enrolled into both groups with the goal of 5 patients/month over a 15-month period.
Acceptability (feasibility)
时间窗: Up to 16 weeks
Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.
Intervention adherence (feasibility)
时间窗: Up to 8 weeks
Adherence will be measured in the intervention group by the number of applied auricular acupressure treatments, with the total possible being 8.
Retention (feasibility)
时间窗: Up to 8 weeks
Retention will be measured by the number of participants who remain in the trial and provide data at the closeout visit.
Intervention fidelity (feasibility)
时间窗: Up to 8 weeks
Fidelity will be assessed by study team adherence to symptom query and appropriate ear seed point modifications to the standard protocol and accuracy of seed placement according to photographic analysis.
次要结局
- Change in appetite(Baseline to week 8)
- Change in body weight (kg)(Baseline to week 8)