ステージ II ～ IV の胃がん、食道がん、膵臓がん患者における食欲と体重に対する耳介指圧の実現可能性
胃がん、食道がん、膵臓がん患者の食欲と体重に対する指圧介入の効果を試験するランダム化比較試験：パイロット研究と実現可能性研究
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
Ancillary studies
他の名前：
Undergo collection of blood samples
他の名前：
Receive usual care
他の名前：
Undergo auricular acupressure
他の名前：
|
|
アクティブコンパレータ：Arm II (usual care)
Patients receive usual care on study. Patients also undergo collection of blood samples on study. |
Ancillary studies
他の名前：
Undergo collection of blood samples
他の名前：
Receive usual care
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Accrual (Feasibility)
時間枠：Up to 2 years, during study accrual
|
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. |
Up to 2 years, during study accrual
|
|
Retention (Feasibility)
時間枠：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. |
Up to 8 weeks
|
|
Intervention Adherence (Feasibility)
時間枠：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. |
Up to 8 weeks
|
|
Intervention Fidelity (Feasibility)
時間枠：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. |
Up to 8 weeks
|
|
Acceptability (Feasibility)
時間枠：Up to 16 weeks
|
Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews. |
Up to 16 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Appetite
時間枠：Baseline to week 4
|
As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 4. The Functional Assessment for Anorexia/Cachexia Treatment Subscale is a 12-item subscale that measures the symptoms and concerns of patients with anorexia/cachexia. The subscale can be used as a standalone instrument. Patients rate each item from 0 to 4 (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very Much). The recall period for each question is "during the past 7 days". As each of the 12 items ranges from 0-4, the range of possible scores is 0-48, with 0 being the worst possible score and 48 the best. To obtain the 0-48 score each negatively-worded item response is recoded so that 0 is a bad response and 4 is good response. |
Baseline to week 4
|
|
Change in Appetite
時間枠：Baseline to week 8
|
As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 8. The Functional Assessment for Anorexia/Cachexia Treatment Subscale is a 12-item subscale that measures the symptoms and concerns of patients with anorexia/cachexia. The subscale can be used as a standalone instrument. Patients rate each item from 0 to 4 (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very Much). The recall period for each question is "during the past 7 days". As each of the 12 items ranges from 0-4, the range of possible scores is 0-48, with 0 being the worst possible score and 48 the best. To obtain the 0-48 score each negatively-worded item response is recoded so that 0 is a bad response and 4 is good response. |
Baseline to week 8
|
|
Change in Body Weight (kg)
時間枠：Baseline to week 4
|
Analyses will assess change in each outcome as a change from baseline to week 4. |
Baseline to week 4
|
|
Change in Body Weight (kg)
時間枠：Baseline to week 8
|
Analyses will assess change in each outcome as a change from baseline to week 8. |
Baseline to week 8
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Blake Langley、Fred Hutch/University of Washington Cancer Consortium
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RG1123492
- RG1123492 (その他の識別子：Fred Hutch/University of Washington Cancer Consortium)
- NCI-2023-03942 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 3KL2TR002317 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data that underlie the results reported in published articles after de-identification may be made available upon request (text, tables, figures, and appendices).
IPD 共有時間枠
Beginning 6 months and ending 36 months after publication of results or study protocol, as requested.
IPD 共有アクセス基準
Researchers and investigators who: 1) provide a methodologically sound proposal to expand on aims in the original, approved proposal; and/or 2) aim to conduct individual, participant-level meta-analyses. Proposals should be directed to blangley@fredhutch.org. To gain access, data requestors will need to sign a data access agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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