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Pre-Transplant Nutrition Counseling in Patients With Multiple Myeloma (PREPARE)

2026年11月5日 更新者:University of Utah

PREPARE: PRE-transPlant Nutrition Counseling to Attenuate Malnutrition and Improve REcovery in Patients With Multiple Myeloma

The primary endpoint of this pilot randomized controlled trial (RCT) will evaluate the feasibility and acceptability of an 8-week pre-hematopoietic stem cell transplant (HSCT) nutrition counseling intervention aimed at improving dietary intake and quality before HSCT to attenuate post-HSCT malnutrition among up to 20 patients with multiple myeloma (MM).

Hypothesis: An 8-week pre-transplant nutrition counseling intervention will be feasible and acceptable among patients with MM undergoing HSCT.

調査の概要

状態

まだ募集していません

詳細な説明

Hematopoietic Stem Cell Transplantation (HSCT) is standard of care for multiple myeloma (MM), yet treatment-related toxicities result in post-transplant malnutrition in up to 80% of patients. Conditioning chemotherapy is associated with substantial toxicities, including severe nausea, vomiting, and mucositis, which impair oral intake and disrupt GI function. Peri-transplant malnutrition is associated with increased healthcare utilization, higher infection risk, greater incidence of mucositis, reduced quality of life (QOL), and worse survival.

This pilot, parallel-group randomized controlled trial evaluates the feasibility and acceptability of an 8-week nutrition counseling intervention designed to improve dietary intake and quality among 20 patients with MM undergoing HSCT (1:1 allocation). Counseling begins at the start of induction therapy and continues for 8 weeks through weekly 30-45 minute video sessions delivered by a registered dietitian. The intervention utilizes stepwise, incremental goals targeting energy intake, protein intake, and fruit/vegetable consumption, monitored via a dietary tracking application. Control participants receive usual standard of care, including written educational materials and one pre-HSCT dietitian consultation 2-3 weeks prior to HSCT to discuss anticipated side effects.

PRIMARY OBJECTIVES I. Conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of an 8-week pre-hematopoietic stem cell transplant (HSCT) nutrition counseling intervention aimed at improving dietary intake and quality before HSCT to attenuate post-HSCT malnutrition among up to 20 patients with multiple myeloma (MM).

EXPLORATORY OBJECTIVES I. Leverage the usual-care control arm to characterize longitudinal changes in protein and energy intake, diet quality, malnutrition risk and status, physical activity, and quality of life from baseline (post-diagnosis, pre-induction therapy) through approximately three weeks post-HSCT to inform refinement of intervention timing, duration, and outcome assessment.

II. Compare the sensitivity and specificity of recommended malnutrition screening tools relative to a validated malnutrition assessment tool to inform selection of the optimal screening tool for patients with multiple myeloma.

III. Estimate the effect of the intervention, compared with usual care, on post-HSCT malnutrition status to inform the design of a larger, adequately powered trial.

研究の種類

介入

入学 (推定)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Subject age >= 18 years old
  • Individuals newly diagnosed with multiple myeloma undergoing hematopoietic stem cell transplantation as part of first line therapy
  • Willingness to engage in virtual nutrition counseling intervention one day per week for eight weeks if assigned to the nutrition counseling group
  • Willingness to complete 1-3 food records using Cronometer dietary tracking app each week for eight weeks if assigned to the nutrition counseling group
  • Willingness to complete four virtual assessment sessions (baseline, post-intervention, pre-HSCT, post-HSCT)
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria:

  • Patients with multiple myeloma for whom hematopoietic stem cell transplantation is not planned
  • Patients who do not speak English will be excluded for this pilot trial due to inadequate funds and staffing to successfully execute this trial in languages other than English

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Nutrition Counseling Intervention

8-week pre-HSCT virtual nutrition counseling intervention (1 session per week, 30-45 minutes) delivered by a registered dietitian and completion of 1-3 weekly dietary tracking a dietary tracking application.

Participants receive one 30-45 minute virtual nutrition counseling session per week for 8 weeks starting on or within 7 days after Cycle 1 Day 1 of induction therapy. Sessions are delivered by a registered dietitian using the Nutrition Care Process framework with stepwise goal setting targeting energy, protein, and fruit/vegetable intake based on food records tracked via a dietary tracking application.

アクティブコンパレータ:Usual Care

Standard clinical care including AICR educational booklet provided on Cycle 1 Day 1 of induction therapy and standard pre-HSCT dietitian consultation 2-3 weeks prior to transplant.

Participants receive standard medical care, including the American Institute for Cancer Research (AICR) Living with Cancer handbook on Cycle 1 Day 1 of induction therapy and a standard dietitian consultation 2-3 weeks prior to HSCT regarding expected treatment side effects.

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
Intervention Feasibility
時間枠:End of 8-week intervention (Week 9)

Feasibility is defined as: (1) >=40% enrollment rate among potentially eligible patients, (2) >=70% completion of the 8-week intervention, and (3) >=70% attendance of >=75% of scheduled counseling sessions (>=6 sessions) and completion of >=1 food record per week.

End of 8-week intervention (Week 9)
Intervention Acceptability
時間枠:End of 8-week intervention (Week 9)

Acceptability assessed using an end-of-intervention survey completed by intervention participants. Considered acceptable if >=80% of all agreement-based responses are "Agree" or "Strongly agree".

End of 8-week intervention (Week 9)

二次結果の測定

結果測定
メジャーの説明
時間枠
Global Leadership Initiative on Malnutrition (GLIM)
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)]

Malnutrition status will be assessed according to the GLIM criteria. A malnutrition diagnosis requires at least one etiologic criterion (reduced food intake or assimilation and/or disease burden or inflammation) and at least one phenotypic criterion (weight loss, low body mass index, and/or reduced muscle mass) are present. Severity is graded as moderate or severe based on the phenotypic criteria.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)]
Malnutrition Screening Tool (MST)
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

The Malnutrition Screening Tool (MST) is a two-question screening tool that assesses malnutrition risk. Scores range from 0-5. Scores >=2 indicate malnutrition risk, whereas scores <2 indicate no risk.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
NUTRISCORE
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

NUTRISCORE includes the MST questions and additional items related to cancer site and anticancer treatment. Scores range from 0 to 11; scores ≥5 indicate malnutrition risk, whereas scores <5 indicate no malnutrition risk.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
Malnutrition Universal Screening Tool (MUST)
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

The MUST assesses BMI, unintentional weight loss, and the acute disease effect. Scores range from 0 to 6. A score of 0 indicates low risk of malnutrition, 1 indicates medium risk, and scores ≥2 indicate high risk of malnutrition.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
Mini Nutritional Assessment-Short Form (MNA-SF)
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

The MNA-SF is a six-item screening tool used to assess nutritional status in older adults. Scores range from 0 to 14; scores of 12-14 indicate normal nutritional status, 8-11 indicate risk of malnutrition, and 0-7 indicate malnutrition.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
Nutrition Risk Screening 2002 (NRS-2002)
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

The NRS-2002 assesses impaired nutritional status, disease severity, and age. Scores range from 0 to 7; scores ≥3 indicate nutritional risk, whereas scores <3 indicate no nutritional risk.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF)
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

The PG-SGA SF is a four-item, patient-completed nutrition screening tool assessing weight history, food intake, nutrition impact symptoms, and activity and function. Scores range from 0-36. A score ≥7 indicates malnutrition risk.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
Protein intake
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

Average daily protein intake, measured in grams per day, will be calculated from 1-3-day food records collected using a dietary tracking application.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
Energy intake
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

Average daily energy intake, measured in kilocalories per day, will be calculated from 1-3-day food records collected using a dietary tracking application.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
Godin Leisure-Time Exercise Questionnaire.
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. The Leisure Score Index is calculated by weighting the weekly frequency of strenuous, moderate, and mild activity by 9, 5, and 3 metabolic equivalents, respectively, and summing the weighted values.

Scores have no fixed upper limit; higher scores indicate greater leisure-time physical activity.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
Mini Eating Assessment Tool (mini-EAT)
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

The Mini-EAT is a nine-item dietary screener that assesses diet quality. Scores range from 0 to 100, with lower scores indicating poorer diet quality and higher scores indicating better diet quality.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
時間枠:Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

The EORTC QLQ-C30 is a 30-item questionnaire that assesses global health status/QOL, physical, role, emotional, cognitive, and social functioning, and cancer-related symptoms. All scale scores range from 0 to 100. Higher global health status/QOL and functioning scores indicate better QOL and functioning, whereas higher symptom scores indicate greater symptom burden.

Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Adriana Coletta, MD、Huntsman Cancer Institute

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月1日

一次修了 (推定)

2028年6月1日

研究の完了 (推定)

2028年12月1日

試験登録日

最初に提出

2026年11月5日

QC基準を満たした最初の提出物

2026年11月5日

最初の投稿 (実際)

2026年11月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月5日

最終確認日

2026年10月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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