Evidence map›Paper›PMID 38280052›Full record

Trial reportBreast cancer research and treatment2024

Randomized placebo-controlled, double-blind clinical trial of nanoemulsion curcumin in women with aromatase inhibitor-induced arthropathy: an Alliance/NCORP pilot trial.

Maryam Lustberg, Patty Fan-Havard, F Lennie Wong, Kasey Hill, Mitch A Phelps, Kevin W Herrera, Ni-Chun Tsai, Timothy Synold, Ye Feng, Chidimma Kalu and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03865992 (Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
6.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03865992 naactive not recruitingnot on this map

Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study

TypeinterventionalSponsorCity of Hope Medical CenterRan2019 to 2026Enrolled42ConditionsBreast Cancer, Joint PainArmsCurcumin, Placebo, Nanoemulsion, Quality-of-Life Assessment, Questionnaire
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. The logarithmic phase as a therapeutic direction: evaluating pharmacological strategies against cancer progression.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Maryam LustbergYale Cancer Center, New Haven, CT, USA.
Patty Fan-HavardKaweah Health Care District, Visalia, CA, USA.
F Lennie WongCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Kasey HillComprehensive Cancer Center, The Ohio State University Wexner Medical Center and James Cancer Hospital, Columbus, OH, USA.
Mitch A PhelpsComprehensive Cancer Center, The Ohio State University Wexner Medical Center and James Cancer Hospital, Columbus, OH, USA.
Kevin W HerreraCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Ni-Chun TsaiCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Timothy SynoldCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Ye FengCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Chidimma KaluCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Mina S SedrakDavid Geffen School of Medicine, University of California, Los Angeles, Los Angeles, USA.
Lisa D YeeCity of Hope Comprehensive Cancer Center, Duarte, CA, USA. lyee@coh.org.ORCID http://orcid.org/0000-0001-8243-1055
City of Hope · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USKaweah Delta Health Care District · USUniversity of California, Los Angeles · USYale Cancer Center · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Daniel G. Stover · 1985 to 2026
$132.3M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI John Charles Williams · 1985 to 2026
$86.3M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
Yale Cancer Center NCTN LAPSUG1CA233337 · NCI · YALE UNIVERSITY · PI ANNE C CHIANG · 2019 to 2026
$6.0M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA016058NCI NIH HHS P30 CA033572NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA233331NCI NIH HHS UG1 CA233337
6 · The paper itself

Abstract

purposeAromatase inhibitor (AI) therapy reduces risk of recurrence and death for postmenopausal women with breast cancer (BC); however, AI-induced arthralgia (AIIA) can lead to discontinuation of treatment. Curcumin, a bioactive polyphenolic substance, may help ameliorate inflammation-related conditions including osteoarthritis and pain.

methodsWe conducted a multisite randomized placebo-controlled, double-blind pilot trial (Alliance A22_Pilot9) to evaluate the effects of nanoemulsion curcumin (NEC, 200 mg/day) in postmenopausal women experiencing AIIA for ≥ 3 months. The primary objective was to determine the feasibility of using Functional Assessment of Cancer Treatment-Endocrine Symptoms (FACT-ES) to detect changes from 0 (T0) to 3 months (T3) of NEC treatment in AI-induced symptoms and well-being; secondary objectives included evaluation of changes in Disabilities of the Shoulder, Arm, and Hand (DASH), Brief Pain Inventory-short form (BPI-SF), grip strength, and biomarkers at T0 and T3.

resultsForty-two patients were randomized to NEC or placebo; 34 women completed the 3-month study. Patient-reported outcome measures (PROMs: FACT-ES, DASH, BPI-SF) and biospecimens were collected at T0-T3 in > 80% of participants. Adherence was ≥ 90% for both arms. PROMs and grip strength did not differ significantly by treatment arm. Plasma curcumin was detected only in NEC arm participants. Serum estradiol and estrone levels were below detection or low on study agent. Gastrointestinal adverse effects were commonly reported in both arms.

conclusionNEC versus placebo in a multisite randomized trial is feasible and well-tolerated. Additional studies with larger sample size are needed to further evaluate the efficacy and safety of NEC in treatment of AIIA. CLINICALTRIALS: gov Identifier: NCT03865992, first posted March 7, 2019.

Indexed as

Aromatase InhibitorsBreast NeoplasmsCurcuminAgedArthralgiaDouble-Blind MethodEmulsionsFemaleHumansMiddle AgedPilot ProjectsPostmenopauseTreatment OutcomeAromatase InhibitorsCurcuminEmulsionsAromatase inhibitors-induced joint arthropathyNanoemulsion curcuminPlasma curcumin levelsPlasma estrone and estradiol levelsPostmenopausal women

Identifiers

PMID38280052
PMCPMC11062803
OpenAlexW4391276990

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.