Strength Training for Head and Neck Cancer Survivors

(LIFTING2 Trial)

Overseen By Stephanie Ntoukas

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Disqualifiers: Recent strength training, Other trials

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether heavy strength training can help head and neck cancer survivors enhance their quality of life by increasing muscle strength and reducing fatigue. Participants in the exercise group will follow a structured program, performing exercises like squats, bench presses, and deadlifts twice a week for 12 weeks. The trial seeks individuals who completed cancer treatment at least a year ago and have good shoulder mobility. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to valuable research.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that heavy strength training is likely to be safe for head and neck cancer survivors?

Research has shown that heavy lifting strength training (HLST) is safe for head and neck cancer survivors. One study found that participants found HLST easy to do and well-received, with no negative side effects reported. This indicates that the exercise program did not cause harm or unexpected issues.

The study also found that heavy lifting can boost muscle strength and power, potentially helping with some side effects of cancer treatments. This information may reassure those considering joining a trial, as it demonstrates that HLST has been tested in similar groups before without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about heavy strength training for head and neck cancer survivors because it explores a non-pharmacological approach to improving survivors' quality of life. Unlike traditional treatments like surgery, radiation, or chemotherapy, which focus on eliminating cancer cells, this method aims to enhance physical strength and overall health through exercises like barbell squats, bench presses, and deadlifts. This approach could potentially reduce fatigue and improve muscle function, offering a supportive therapy that complements existing medical treatments. By focusing on physical rehabilitation, this intervention may help survivors regain strength and vitality, fostering a holistic recovery process.

What evidence suggests that heavy strength training might be an effective treatment for head and neck cancer survivors?

Research shows that heavy lifting strength training (HLST), which participants in this trial may receive, might help head and neck cancer survivors feel better after treatment. A small initial study found that HLST could boost muscle strength and physical ability in these individuals. Earlier studies on general exercise for cancer survivors have also shown improvements in both physical skills and health perceptions. Importantly, these exercises did not cause any negative side effects for participants. HLST might be even more beneficial than lighter exercises, but more research is needed to confirm this. ^{2 5 6 7 8}

Who Is on the Research Team?

Kerry Courneya

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for head and neck cancer survivors who have finished their treatment. It's designed to see if heavy lifting strength training can help with muscle strength, physical function, fatigue, and swallowing issues that affect life quality.

Inclusion Criteria

Approved for exercise by oncologist and a certified exercise physiologist or kinesiologist

I have any type or stage of head and neck cancer.

No unmanaged medical conditions, alcohol, or drug abuse

Exclusion Criteria

Has met the Canadian Physical Activity strength training guidelines within the past one month: at least two days per week of muscle and bone strength training activities using major muscle groups

Currently involved in a different exercise trial or clinical drug trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the exercise group undergo 12 weeks of heavy lifting strength training, while the usual care group continues their typical routine without new exercise programs.

12 weeks

24 supervised exercise sessions for the exercise group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of muscular strength, physical function, and quality of life.

4 weeks

Optional Extension

Participants in the usual care group are offered a 4-week introduction to heavy lifting strength training program and/or referred to a community-based exercise program.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Heavy Strength Training

Trial Overview The LIFTING 2 trial is testing the benefits of a heavy lifting strength training program compared to no exercise at all in people who've survived head and neck cancer. The goal is to improve their muscular strength and overall well-being.

How Is the Trial Designed?

Group I: Exercise Group Experimental Treatment 1 Intervention

The exercise intervention will consist of 24 supervised, heavy lifting strength training exercise sessions over a 12 week period. The exercise frequency will be two times per week. Main exercises will consist of barbell back squat, bench press, and dead lift.

Group II: Usual Care Group Active Control 1 Intervention

Participants randomized to the usual care group will be asked to continue will their typical daily routine during the 12 week study period, and not begin any new exercise program to increase their exercise levels from baseline. They will not receive any information or education regarding exercise. After the postintervention assessments, participants in the usual care group will be offered a 4-week introduction to heavy lifting strength training program and/or referred to a community-based exercise program

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

In a study of 48 head and neck cancer patients undergoing treatment, significant loss of lean body mass (LBM) was observed as early as two weeks into radiation therapy, with further declines noted through week six.

Patients receiving cisplatin-based chemoradiation (CCRT) experienced a greater loss of LBM (3.1 kg) compared to those receiving radiation alone, highlighting the impact of CCRT on muscle health during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated loss of lean body mass in head and neck cancer patients during cisplatin-based chemoradiation. Lønbro, S., Gam, S., Hermann, AP., et al.[2023]

Progressive resistance training (PRT) significantly increased lean body mass and muscle strength in head and neck squamous cell carcinoma (HNSCC) patients after radiotherapy, regardless of whether the training started early or was delayed.

Patients who began PRT earlier showed greater improvements in quality of life compared to those who started later, highlighting the benefits of early intervention in enhancing recovery post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive resistance training rebuilds lean body mass in head and neck cancer patients after radiotherapy--results from the randomized DAHANCA 25B trial. Lønbro, S., Dalgas, U., Primdahl, H., et al.[2019]

A 12-week progressive resistance training (PRT) program during concomitant chemoradiotherapy (CCRT) for head and neck cancer was feasible, with 75% of participants completing the majority of sessions and reporting high satisfaction.

The PRT helped maintain functional performance and regain muscle strength, with lean body mass starting to increase immediately after treatment, indicating potential benefits for patients undergoing CCRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive resistance training in head and neck cancer patients undergoing concomitant chemoradiotherapy. Lonkvist, CK., Vinther, A., Zerahn, B., et al.[2020]

The LIFTING trial demonstrated that heavy lifting strength training (HLST) is feasible and safe for head and neck cancer survivors, with 100% of participants successfully completing the program and no adverse events reported.

Participants showed significant improvements in muscular strength, with median increases of 34 kg in squat/leg press, 6 kg in bench press, and 12 kg in deadlift over the 12-week program, indicating HLST may enhance physical functioning in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of Heavy Lifting Strength Training in Head and Neck Cancer survivors post-surgical neck dissection (the LIFTING trial). Ntoukas, SM., McNeely, ML., Seikaly, H., et al.[2023]

The exercise program for head and neck cancer patients undergoing chemoradiotherapy showed low overall adherence (54%) and retention (65%), indicating that while the program is feasible for some, it needs improvements to engage more patients effectively.

Despite the intention to counteract negative effects of treatment, significant declines in grip strength, fat-free mass, and quality of life were observed, suggesting that the current exercise intervention may not sufficiently mitigate the adverse impacts of chemoradiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a supervised and home-based tailored exercise intervention in head and neck cancer patients during chemoradiotherapy. Kok, A., Passchier, E., May, AM., et al.[2022]

Exercise-based rehabilitation can improve functionality and reduce fatigue in head and neck cancer survivors who have undergone chemoradiotherapy, as shown in a meta-analysis of 18 studies involving 1322 participants.

Despite the benefits in functionality, the study found no significant improvements in the overall quality of life for these survivors, indicating that while exercise may help with physical aspects, it does not necessarily enhance overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based rehabilitation on functionality and quality of life in head and neck cancer survivors. A systematic review and meta-analysis. Pérez, IMM., Pérez, SEM., García, RP., et al.[2023]

A 12-week strength training program, including novel strength training (NST) with eccentric overload and neuromuscular electrical stimulation (NMES), was feasible for head and neck cancer patients, showing high completion (100% NST, 82% CST) and adherence rates (92% NST, 81% CST).

Both NST and conventional strength training significantly improved muscle strength, muscle size, and health-related quality of life, suggesting that these interventions can effectively aid recovery after head and neck cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of eccentric overloading and neuromuscular electrical stimulation to improve muscle strength and muscle mass after treatment for head and neck cancer. Lavigne, C., Twomey, R., Lau, H., et al.[2021]

Progressive resistance training (PRT) is feasible and well-tolerated in patients with head and neck squamous cell carcinoma (HNSCC), with a high adherence rate of 97% over 12 weeks.

Both the PRT group with protein and creatine supplementation and the placebo group showed significant increases in lean body mass, muscle strength, and functional performance, indicating that PRT can effectively enhance physical health in HNSCC patients, regardless of dietary supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of progressive resistance training and dietary supplements in radiotherapy treated head and neck cancer patients--the DAHANCA 25A study. Lønbro, S., Dalgas, U., Primdahl, H., et al.[2019]

Only a small percentage of head and neck cancer survivors engage in regular exercise, with 44% reporting light exercise and only 8.5% meeting public health guidelines, indicating a significant need for increased physical activity in this group.

Total exercise minutes were positively associated with functional well-being and quality of life, while also being negatively associated with fatigue, suggesting that even light exercise could improve health outcomes for these survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and quality of life in head and neck cancer survivors. Rogers, LQ., Courneya, KS., Robbins, KT., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12244484/

Feasibility and preliminary efficacy of heavy Lifting Strength ... Here, we propose the Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training versus Usual Care in Head and Neck Cancer Survivors ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10201044/

Feasibility and safety of Heavy Lifting Strength Training in ... The primary aim of the LIFTING trial was to examine the feasibility and safety of a HLST program in HNCS ≥1-year post-surgical neck dissection.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1368837521000762

Effectiveness of physical activity interventions in improving ... Physical activity interventions in HNC survivors often conferred some improvement in objective and patient-reported outcomes.

4. link.springer.com link.springer.com/article/10.1007/s00520-023-08126-2

Effect of exercise across the head and neck cancer ... The study reported a recruitment rate of 22%, an overall adherence to resistance training of 95%, and no adverse events were registered. After ...

5. go.gale.com go.gale.com/ps/i.do?id=GALE%7CA847256899&sid=sitemap&v=2.1&it=r&p=HRCA&sw=w

Feasibility and preliminary efficacy of heavy Lifting Strength ... Heavy lifting strength training (HLST) may further improve outcomes, however, only one pilot study has focused on HNCS. The primary aim of this ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37212970/

Feasibility and safety of Heavy Lifting Strength Training in ... Conclusions: HLST appears feasible and safe for HNCS and may result in meaningful improvements in muscular strength. Future research should ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0326860

Feasibility and preliminary efficacy of heavy Lifting Strength ... In addition, the literature demonstrates that exercising with heavy loads (>75% 3RM) is safe and effective for improving muscular strength, muscular power, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01332682

Resistance Training and Physical Functioning in Head ... The purpose of this feasibility study is to examine the safety and effect of resistance training on muscle strength, lean body mass, physical functioning, ...