Supplemental Evidence and Data Request on Nutrition as Prevention for Improved Cancer Outcomes
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our revi...
Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION:
Request for supplemental evidence and data submissions.
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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.
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:
epc@ahrq.hhs.gov.
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:
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.
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.
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.
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
( printed 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?
KQ2: nutritional interventions during treatment (NIDTs)
KQ3: pre- or during treatment nutritional interventions (NIs) and patient-centered outcomes
KQ4: weight loss in overweight/obese adults with cancer
Population
Adults diagnosed with cancer at or after age 18 who have or are at risk for cancer-associated malnutrition.
Subgroups:
• Cancer and treatment characteristics (cancer type, 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).
Overweight (BMI 25–<30)/obese (BMI ≥30) adults ≥18y of age diagnosed with cancer.
Interventions
Nutritional interventions under the supervision of a nutrition professional (
e.g.,
dietician, nutritionist, or other licensed clinicians).
Nutritional Interventions intended for weight loss (includes both PNIs and NIDTs).
• Diet or nutrition therapy (via oral or enteral (
e.g.,
nasogastric, gastrostomy, jejunostomy) feeding.
○ Special diets (
e.g.,
fasting (intermittent or short-term), calorie restriction, ketogenic, Mediterranean diet, high calorie, high protein).
Use this for formal legal and research references to the published document.
86 FR 59718
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Supplemental Evidence and Data Request on Nutrition as Prevention for Improved Cancer Outcomes,” thefederalregister.org (October 28, 2021), https://thefederalregister.org/documents/2021-23456/supplemental-evidence-and-data-request-on-nutrition-as-prevention-for-improved-cancer-outcomes.