Prehabilitation for Lung and Esophageal Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Unable to provide informed consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with lung or esophageal cancer improve their health before surgery through prehabilitation. Participants will join an 8-week program focusing on better nutrition, quitting smoking, improving sleep, and increasing physical activity to enhance overall well-being and recovery chances. One group will follow this program, while the other will receive usual care for comparison. Individuals diagnosed with lung or esophageal cancer, scheduled for surgery in at least two weeks, and with their surgeon's approval, may be suitable candidates. As an unphased trial, this study offers a unique opportunity to enhance health and recovery potential before surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this prehabilitation program is safe for patients with lung and esophageal cancer?

Research has shown that prehabilitation is generally safe for people with cancer. A review of studies found it safe and feasible for various cancer types, including lung cancer. Recent research identified benefits such as improved lung function and shorter hospital stays after surgery. Overall, prehabilitation appears to enhance outcomes and is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prehabilitation for lung and esophageal cancer because it focuses on preparing patients physically and mentally before surgery, unlike the standard of care which primarily kicks in after surgery. This prehab program is community-based and spans 8 weeks, offering a holistic approach that includes exercise, nutrition, and psychological support. By enhancing patients' strength and resilience ahead of time, prehabilitation aims to improve recovery outcomes and potentially shorten hospital stays.

What evidence suggests that this prehabilitation program is effective for lung and esophageal cancer?

Research shows that preparing both physically and mentally before surgery, known as prehabilitation, can improve surgical outcomes. In this trial, participants in the "Prehab" arm will complete an 8-week community-based prehab program. Studies have found that individuals who undergo prehabilitation before lung cancer surgery experience fewer complications in the first 30 days post-operation. This program typically includes exercises, nutrition tips, and other lifestyle changes to enhance overall health. By boosting fitness and nutrition, prehabilitation aids patients in recovering faster and more effectively after surgery. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been diagnosed with lung or esophageal cancer and are scheduled for surgery in at least two weeks. Participants must be able to read and write English, have their surgeon's approval, and be capable of giving informed consent.

Inclusion Criteria

I am over 18 years old.

I am scheduled for surgery in at least 2 weeks.

Surgeon approval

Exclusion Criteria

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in an 8-week personalized prehabilitation health coaching program including nutrition, smoking cessation, sleep hygiene, and movement.

8 weeks

4-6 visits (in-person or virtual)

Surgery and Immediate Post-Surgery Support

Participants undergo surgery for lung or esophageal cancer, followed by immediate post-surgery support including one session while in hospital.

1 week

Follow-up

Participants receive support through counseling and scheduled sessions for a month after surgery.

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation

Trial Overview The trial tests a prehabilitation health coaching program designed to improve patients' overall health before major surgery. The 8-week program includes nutrition guidance, smoking cessation support, sleep hygiene advice, and exercise routines.

How Is the Trial Designed?

Group I: Prehab Experimental Treatment 1 Intervention

Complete an 8-week community based prehab program.

Group II: Control Active Control 1 Intervention

Receive standard of care

Prehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in United States as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in Canada as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Published Research Related to This Trial

The Prehab4Cancer (P4C) program in Greater Manchester successfully engaged 377 lung cancer patients, with 80% attending initial assessments and 47.7% completing prehabilitation sessions, indicating high feasibility and uptake.

Patients who participated in the P4C program showed significant improvements in physical fitness, with a mean increase of 50 meters in the incremental shuttle walk test, suggesting that prehabilitation can enhance patient outcomes before lung cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of a real-world regional lung cancer prehabilitation programme in the UK. Bradley, P., Merchant, Z., Rowlinson-Groves, K., et al.[2023]

The study aimed to implement a prehabilitation program for high-risk patients undergoing major abdominal cancer surgery, but it did not meet its targets for recruitment, retention, and adherence, highlighting challenges in engaging patients in such programs.

Out of 238 screened patients, only 50 participated, and while retention was relatively high at 84%, adherence to the exercise regimen was low, with only 28% of participants reporting compliance above 70%, indicating a need for better strategies to encourage participation in prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in high-risk patients scheduled for major abdominal cancer surgery: a feasibility study. Waterland, JL., Ismail, H., Granger, CL., et al.[2022]

A novel four-week multimodal prehabilitation program for lung cancer patients was feasible, with a recruitment rate of 58.6% and high adherence rates to exercise and nutritional components, despite interruptions due to the COVID-19 pandemic.

While the prehabilitation group showed a mean improvement in functional capacity (measured by the 6-minute walk test) compared to standard care, the difference was not statistically significant, and there were no notable changes in health-related quality of life between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a novel mixed-nutrient supplement in a multimodal prehabilitation intervention for lung cancer patients awaiting surgery: A randomized controlled pilot trial. Ferreira, V., Lawson, C., Carli, F., et al.[2022]

Enhanced prehabilitation (EP) for patients with esophageal cancer significantly improved preoperative and postoperative exercise tolerance, as shown by higher 6-minute walk distances compared to the control group (492.9 m vs. 418.9 m preoperatively).

EP also led to a notable reduction in respiratory complications, with only 4.3% of patients experiencing issues compared to 36% in the control group, and completely eliminated the incidence of atelectasis in the EP group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced prehabilitation for patients with esophageal cancer undergoing esophagectomy. Akiyama, Y., Sasaki, A., Fujii, Y., et al.[2022]

Prehabilitation, especially multimodal approaches, significantly reduces the incidence of postoperative complications and shortens hospital stays for patients undergoing surgery for esophagogastric cancer, based on a meta-analysis of 12 studies involving 910 patients.

While prehabilitation improved outcomes like reducing pulmonary and severe complications, it did not significantly affect 30-day readmission rates or in-hospital mortality, indicating its specific benefits in recovery rather than overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of unimodal or multimodal prehabilitation on patients undergoing surgery for esophagogastric cancer: a systematic review and meta-analysis. Zhao, B., Zhang, T., Chen, Y., et al.[2023]

A pilot prehabilitation program for patients with locally advanced esophageal cancer was found to be feasible and well-received, potentially reducing the need for hospital admissions during neoadjuvant therapy (27.3% vs. 54.5% in the control group).

Patients in the prehabilitation group experienced less weight loss during treatment (3.0% vs. 4.3%) and had lower postoperative readmission rates (0.0% vs. 18.2% within 30 days), suggesting that prehabilitation may improve surgical outcomes, although the small sample size limits statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Prehabilitation Program for Patients With Esophageal Cancer During Neoadjuvant Therapy and Surgery. Dewberry, LC., Wingrove, LJ., Marsh, MD., et al.[2019]

In a study of 92 patients with oesophageal cancer, those who participated in a multimodal prehabilitation program had a significantly higher rate of completing their neoadjuvant chemotherapy compared to those who did not receive prehabilitation (p = 0.029).

The results suggest that prehabilitation may enhance patients' tolerance to chemotherapy, indicating a potential benefit for optimizing cancer treatment, although further research is needed to explore its long-term effects on cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Prehabilitation Improves Tolerance to Chemotherapy in Patients with Oesophageal Cancer. Christodoulidis, G., Halliday, LJ., Samara, A., et al.[2023]

In a study of 67 oesophageal cancer patients, a personalized pre-operative exercise program helped maintain and even improve cardiorespiratory fitness during neoadjuvant chemotherapy, with significant increases noted just before surgery.

Higher adherence to the exercise program and greater volumes of physical activity were linked to a lower risk of post-operative pneumonia, emphasizing the importance of consistent exercise during prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. Halliday, LJ., Doganay, E., Wynter-Blyth, V., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12568610/

Prehabilitation: preoperative rehabilitation interventions for ... Recent studies have reported improved postoperative outcomes, including in individuals undergoing cancer surgery, highlighting benefits at multiple levels, such ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022522325001734

The effect of multimodal prehabilitation on postoperative ... Multimodal prehabilitation significantly reduced overall and major postoperative 30-day complications in lung cancer surgery.

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06573788

Multidisciplinary Prehabilitation Management Pathway and ... The goal of this clinical trial is to learn if "Prehabilitation model for Internet+ devices"improve patients' preoperative status and reduce the postoperative ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11494964/

Efficacy of Prehabilitation in cancer patients: an Rcts ... Patients with cancer (PwC) who undergo specific treatments reported greater fatigue and reduced functional capacity as predominant outcomes, ...

5. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/2020/09000/two_week_multimodal_prehabilitation_program.26.aspx

Two-Week Multimodal Prehabilitation Program Improves... The current study investigated the impact of a short-term, home-based, multimodal prehabilitation program on perioperative functional capacity in patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12318388/

Feasibility, safety and preliminary effect of exercise ... Increasing evidence underscores the effectiveness of prehabilitation in improving postoperative outcomes in patients with cancer.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2347562524001380

Summary of the best evidence for prehabilitation ... In this context, a systematic review has demonstrated the safety and feasibility of prehabilitation across various cancers, including lung cancer, demonstrating ...