Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT07050771
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bladder Cancer
  • Hepatopancreaticobiliary (HPB) Malignancy
  • Kidney Cancers
  • Ovarian Cancer (OvCa)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Comprehensive multimodal prehabilitation (CMMP) — OTHER
    Components of the CMMP intervention (which will be administered for at least 3 weeks from study registration to the Preoperative Reassessment) will include: 1) Motivational interviewing: 2 sessions, 10-15 minutes each. 2) Nutritional prehabilitation (a supplement containing 18-22g high quality protein consumed 2 times/day, 7 days/week). 3) Inspiratory muscle training using a hand-held inspiratory muscle device, 5 minutes of respiratory muscle training twice/day, 5 days per week. 4) Physical prehabilitation a) aerobic exercise (20 minutes of moderate-intensity exercise at least 3 days/week) and b) strength resistance training using resistance bands (3 sets of 10 repetitions at moderate intensity at least 3 days/week).

Study Details

In this 2-arm, non-randomized, phase II trial, the investigators will evaluate the efficacy and safety of comprehensive multimodal prehabilitation (CMMP) alone or in combination with planned neoadjuvant (NAT) in pre-frail/frail patients with probable/proven pancreaticobiliary, ovarian, kidney, or bladder cancer prior to elective major cancer surgery (EMCS).

Key Dates

Start date
Aug 14, 2025
Status verified
Mar 2026
Primary completion
Jul 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
148 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CMMP intervention
    Participants will receive the CMMP intervention, which includes motivational interviewing, nutritional prehabilitation (nutritional assessment/counseling and protein supplementation), inspiratory muscle training, and physical prehabilitation (aerobic and strength/resistance training) for at least 3 weeks prior to elective major cancer surgery.
  • Experimental: Planned neoadjuvant therapy/CMMP intervention
    Participants will receive the CMMP intervention (in conjunction with planned, off-protocol neoadjuvant therapy), which includes motivational interviewing, nutritional prehabilitation (nutritional assessment/counseling and protein supplementation), inspiratory muscle training, and physical prehabilitation (aerobic and strength/resistance training) for at least 3 weeks prior to elective major cancer surgery.

Primary Outcome Measure

Rate of morbidity-free survival [ Time Frame: At 30 days postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Neal Cancer CenterHoustonTexas77030
Safiya Joseph
[email protected]
3462382420
Titilayo Olubajo
[email protected]
7133639803
Nestor Esnaola, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Houston Methodist Neal Cancer Center· Houston, TX

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