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WithdrawnNCT06442397HEALUpdated Aug 20, 2025

Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors

An interventional study of Anti-Inflammatory Lifestyle Intervention in Survivorship, sponsored by Virginia Commonwealth University. Withdrawn. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Unable to enroll a sufficient number of participants to launch a cohort despite increased recruitment efforts
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 29 Years
Sex
All
01

Study summary

To test the feasibility and acceptability of AILI and associated research procedures among emerging adult cancer survivors (EACS, N=16) age 18-29.

Read the detailed description

This is a single-arm pilot trial designed to assess the feasibility and acceptability of an anti-inflammatory lifestyle intervention (AILI) for emerging adults (EA) adapted for emerging adult cancer survivors (EACS).

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Conditions studied

  • Survivorship

Keywords

  • Adult Cancer Survivors
  • Anti-Inflammatory Lifestyle for Cancer Survivors
03

In context

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-29
  • Cancer diagnosis of any type
  • Body fat percentage >16.2% for women; >10.6% for men

Exclusion criteria

Exclusion Criteria:

  • Individuals receiving active chemotherapy/radiation or those having completed active chemotherapy/radiation within the past 6 months
  • Individuals who are currently pregnant or lactating
  • Current involvement in a weight loss program or current use of weight loss medication
  • Individuals who report any other uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity (e.g., uncontrolled hypertension)
  • Individuals with rheumatologic and gastrointestinal conditions associated with severe systemic inflammation (e.g., rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease)
  • Individuals with medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis (e.g., endogenous hypercortisolemia [Cushing's syndrome] or adrenal insufficiency)
  • Individuals who report a heart condition, chest pain during periods of activity or rest, or loss of consciousness as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)
  • Report of lifetime diagnosis of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors (vomiting, laxative abuse) within the previous 3 months
  • Hospitalization for depression or other psychiatric disorder within the past 12 months
  • Report of lifetime diagnosis of bipolar disorder or psychotic disorder
  • Indication of current suicidal intent
  • Inability to speak and read English
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Anti-Inflammatory Lifestyle Intervention

    A 16-week program consisting of 12 75-minute virtual group meetings

    Behavioral: Anti-Inflammatory Lifestyle Intervention

Interventions

  • BehavioralAnti-Inflammatory Lifestyle Intervention

    Content includes training in empirically-supported strategies to improve psychological function (e.g., restructuring negative thoughts, distress tolerance), with a focus on changing discrete behaviors linked to inflammation (e.g., sleep, processed foods, physical activity), all intertwined with evidence-based behavior change content adapted to meet the needs of EACS. Participants will also receive digital tools to facilitate daily self-monitoring (Fitbit activity monitor, wireless scales, self-monitoring app) and generate information for tailored weekly e-coaching

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What researchers measure

Primary outcomes

  1. Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29

    The percentage of participants that enroll

    Time frame: Day 0, At end of recruitment period

  2. Test the feasibility of AILI and associated research procedures among EACS age 18-29

    The percentage of participants that complete the post intervention questionnaire

    Time frame: 4 months

  3. Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29.

    The percentage of participants that complete the post intervention blood draw

    Time frame: 4 months

  4. Assess the acceptability of AILI and associated research procedures among EACS age 18-29.

    The percentage of participants that complete all study sessions

    Time frame: 4 months

  5. Assess the acceptability of AILI and associated research procedures among EACS age 18-29.

    The percentage of participants that wear the Fitbit \>/= 60% throughout the intervention period.

    Time frame: 4 months

  6. Assess the acceptability of AILI and associated research procedures among EACS age 18-29.

    Intervention satisfaction ratings\>/= 4 on a 1-5 Likert scale at 4 months, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.

    Time frame: 4 months

  7. Assess the acceptability of AILI and associated research procedures among EACS age 18-29.

    Research procedure satisfaction ratings\>/= 3 on a 1-5 Likert scale, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.

    Time frame: 4 months

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — There are no plans to share individual participant data at this time.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06442397
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Jun 4, 2024
Start date
Oct 30, 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Last update
Aug 20, 2025

Study contacts

Autumn Lanoye, Ph.D
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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