[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59718-59720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Nutrition as Prevention 
for Improved Cancer Outcomes

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Nutrition as 
Prevention for Improved Cancer Outcomes, which is currently being 
conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. 
Access to published and unpublished pertinent scientific information 
will improve the quality of this review.

DATES: Submission Deadline on or before November 29, 2021.

ADDRESSES: 
Email submissions: [email protected]

Print submissions:

Mailing Address: Center for Evidence and Practice Improvement, Agency 
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857

Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice 
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC 
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 
20857

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Nutrition as 
Prevention for Improved Cancer Outcomes. AHRQ is conducting this 
technical brief pursuant to Section 902 of the Public Health Service 
Act, 42 U.S.C. 299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Nutrition as Prevention for Improved Cancer Outcomes, 
including those that describe adverse events. The entire research 
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/improved-cancer-outcomes/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Nutrition as Prevention for Improved Cancer 
Outcomes helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: Study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the EPC Program. This is a 
voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

Key Questions (KQ)

    KQ 1: In adults diagnosed with cancer who have or are at risk for 
cancer-associated malnutrition, what is the effect of nutritional 
interventions prior to cancer treatment in preventing negative 
treatment outcomes such as effects on dose tolerance, hospital 
utilizations, adverse events and survival?
    a. Do the effects of nutritional interventions on preventing the 
negative outcomes associated with cancer treatment vary by cancer type, 
treatment type (chemotherapy, radiation, surgery) and stage of disease?
    b. Do the effects of nutritional interventions vary across the 
lifespan (e.g., adults aged >=65 years vs. <65 years)?
    c. KQ1c: Compared to adults without muscle wasting, do nutritional 
interventions prevent the negative outcomes associated with cancer

[[Page 59719]]

treatment in adults with muscle wasting?
    d. KQ1d: Do the effects of nutritional interventions on preventing 
the negative outcomes associated with cancer treatment vary across 
special populations (e.g., individuals with multiple comorbid 
conditions)?
    KQ 2: In adults diagnosed with cancer who have or are at risk for 
cancer-associated malnutrition, what is the effect of nutritional 
interventions during cancer treatment in preventing negative treatment 
outcomes such as effects on dose tolerance, hospital utilizations, 
adverse events and survival?
    a. Do the effects of nutritional interventions on preventing the 
negative outcomes associated with cancer treatment vary by cancer type, 
treatment type (chemotherapy, radiation, surgery) and stage of disease?
    b. Do the effects of nutritional interventions vary across the 
lifespan (e.g., adults aged >=65 years vs. <65 years)?
    c. Compared to adults without muscle wasting, do nutritional 
interventions prevent the negative outcomes associated with cancer 
treatment in adults with muscle wasting?
    d. Do the effects of nutritional interventions on preventing the 
negative outcomes associated with cancer treatment vary across special 
populations (e.g., individuals with multiple comorbid conditions)?
    KQ 3: In adults diagnosed with cancer who have or are at risk for 
cancer-associated malnutrition, what is the effect of nutritional 
interventions prior to or during cancer treatment on associated 
symptoms such as fatigue, nausea and vomiting, appetite, physical and 
functional status (e.g., frailty), and quality of life?
    a. Do the effects of nutritional interventions on symptoms 
associated with cancer treatment vary by cancer type, treatment type 
(chemotherapy, radiation, surgery) and stage of disease?
    b. Do the effects of nutritional interventions vary across the 
lifespan (e.g., adults aged >=65 years vs. <65 years)?
    c. Compared to adults without muscle wasting, do nutritional 
interventions differentially effect symptoms associated with cancer 
treatment in adults with muscle wasting?
    d. Do the effects of nutritional interventions on symptoms 
associated with cancer treatment vary across special populations (e.g., 
individuals with multiple comorbid conditions)?
    KQ 4: In adults with cancer who are overweight or obese, what is 
the effect of nutritional interventions intended for weight loss prior 
to or during cancer treatment in preventing negative treatment outcomes 
such as effects on dose, hospital utilizations, adverse events and 
survival?

Contextual Question (CQ)

    CQ 1: What evidence is available on the cost-effectiveness of 
nutritional interventions for preventing negative outcomes associated 
with cancer treatment?

                     PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)
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                                                                  KQ3: pre- or during
                        KQ1: pre-treatment   KQ2: nutritional    treatment nutritional     KQ4: weight loss in
        PICOTS              nutritional        interventions    interventions (NIs) and  overweight/obese adults
                           interventions     during treatment       patient-centered           with cancer
                              (PNIs)              (NIDTs)               outcomes
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Population............  Adults diagnosed with cancer at or after age 18 who have or are  Overweight (BMI 25-<30)/
                         at risk for cancer-associated malnutrition.                      obese (BMI >=30)
                        Subgroups:                                                        adults >=18y of age
                         Cancer and treatment characteristics (cancer type,       diagnosed with cancer.
                         treatment type (systemic therapy, radiation, surgery), stage
                         of disease).
                         Adults >=65y vs younger.
                         Muscle wasting (e.g., sarcopenia, cachexia, pre-
                         cachexia) vs. no muscle wasting.
                         Special populations (individuals with multiple co-
                         morbid conditions).
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Interventions.........  Nutritional interventions under the supervision of a nutrition   Nutritional
                         professional (e.g., dietician, nutritionist, or other licensed   Interventions intended
                         clinicians).                                                     for weight loss
                                                                                          (includes both PNIs
                                                                                          and NIDTs).
                         Diet or nutrition therapy (via oral or enteral (e.g.,
                         nasogastric, gastrostomy, jejunostomy) feeding.
                        [cir] Special diets (e.g., fasting (intermittent or short-
                         term), calorie restriction, ketogenic, Mediterranean diet,
                         high calorie, high protein).
                        [cir] Supplements.
                         Total parenteral therapy.
                         Nutritional counseling.
                         Combined nutritional interventions (e.g., nutritional
                         counseling with nutrition therapy).
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Comparators...........  Standard of care    Standard of care    Standard of care vs      Standard of care vs
                         vs PNIs or PNIs     vs NIDTs, NIDT vs   PNIs or NIDTs, NIDTs     PNIs or NIDTs, NIDTs
                         vs PNIs.            NIDT or PNIs vs.    vs. NIDTs, PNIs vs.      vs. NIDTs, PNIs vs.
                                             NIDTs.              PNIs, PNIs vs NIDTs.     PNIs, PNIs vs NIDTs.
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Outcomes..............  Intermediate Outcomes                                            Intermediate Outcomes.
                        BMI, Body composition, Weight (loss,    Fatigue, nausea and      BMI, Body composition,
                         gain).                                  vomiting, appetite,      Weight (loss, gain).
                                                                 physical/functional
                                                                 status (e.g., frailty).
                        Final Outcomes.                                                  Final Outcomes.
                        Cancer treatment tolerance: treatment   Quality of life........  Cancer treatment
                         interruptions, reductions, or delays.                            tolerance: treatment
                                                                                          interruptions,
                                                                                          reductions, or delays.
                        Hospital utilizations: ER visits,                                Hospital utilizations:
                         Admissions, Length of stay.                                      ER visits.
                                                                                         Admissions, Length of
                                                                                          stay.
                        Adverse events.                                                  Adverse events.
                         Chemotherapy/radiation                                   Chemotherapy/
                         therapy limiting toxicity.                                       radiation therapy
                                                                                          limiting toxicity.
                         Post-op complication.                                    Post-op
                                                                                          complication.
                         NI-related AEs.                                          NI-related
                                                                                          AEs.
                         Unintended harms.                                        Unintended
                                                                                          harms.
                        Survival.                                                        Survival.
                        Nutritional status.                                              Nutritional Status.
                        Malnutrition (underweight, wasting,                              Malnutrition
                         overweight).                                                     (underweight, wasting,
                                                                                          overweight).
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[[Page 59720]]

 
Timing................  Nutritional interventions delivered pre- cancer treatment (KQ1, KQ3, KQ4) and during
                         cancer treatment (KQ2, KQ3, KQ4).
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Setting...............  Outpatient Oncology Care, Ambulatory Care, Cancer Treatment Centers, inpatient, home-
                         based, hospice, telemedicine.
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Abbreviations: KQ = key question; BMI = body mass index; ER = emergency room; PICOTS = population, intervention,
  comparator, outcomes, timing, setting; RCT = randomized controlled trial; NRCT = non-randomized controlled
  trial.


    Dated: October 22, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-23456 Filed 10-27-21; 8:45 am]
BILLING CODE 4160-90-P